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PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman
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Vol. 12 | No. 2 | SEPTEMBER 2013 | MUMBAI | ` 150
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EXPERT’S TAKE 10
Access to Medicine: Moral Imperative and a New Consciousness - Part 3 – Jenik Radon, Maree Newson
INTERVIEW 16
On the Lipaglyn Launch – Pankaj Patel
16
FEATURES 20
Changing Quality and cGMP Environment - A Pharma Industry Insight – Dr B V Sivakumar
24
Advanced Cell Screening Technologies Accelerate Drug Discovery Process – Johan Pihl, Mattias Karlsson
30
Case Study: Ipca Chooses Seclore Filesecure on the Cloud to Protect Critical IP – Ashok Nayak
14 34
Pharma Seals Made Safer with Butyl Rubber – Rupesh Shah
MARKET RESEARCH 38
The Fall of the Rupee and its Impact on Pharma – Dr Saneesh Edacherian
NEWS FEATURE 42
Thalidomide Tragedy Revisited – Ananya Sen
34 NEWS UPDATE 46 59
Pharma News Biotech News
CORPORATE AFFAIRS 63 68
Product Trends Events Diary
BACKYARD 44
69 70
Bookshelf AD Index Next Issue Focus: Biopharmaceuticals
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expert's take
Access to Medicine:
Moral Imperative and a New Consciousness Part 3
Jenik Radon
Adjunct Professor of International and Public Affairs, Columbia School of International and Public Affairs
Maree Newson
Associate (NZ Qualified) Radon Law Offices, New York
This series of articles has explained how the HIV/ AIDS epidemic brought “access to medicine” to the forefront of public debate, what the “human right to health” means, and how we might begin to identify the illnesses that trigger this right.
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ow we ask, which medicines can we identify as “essential”? Are there some medicines that are not “lifesaving” as such, but that nevertheless should be accessible by everyone? For example, should we also provide access to medicines that help to relieve chronic pain and suffering, some of which may over years shorten a lifespan? Who gets to decide when the “new and improved” version of a patented drug should become the standard for all? Defining “essential medicines” is clearly a challenge as this also requires a multiple of decisions, including a judgment on what illnesses are to be prioritised in treatment. In that regard we will also discuss how our societies as well as economies could be improved if medicines to address a broader range of conditions were available to all. From a purely utilitarian perspective, healthy workers are simply more productive. Defining Essential Medicines
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Although one can persuasively, and morally, argue that all people have the
Specific medicines must be identified that set the floor for what should be provided to all patients, no matter in what country they live in.
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right to receive the same medical services throughout the world, it is not feasible --and it costs. For example, medicines for a given illness can have different levels of quality, efficacy and safety, terms that are not simply words in the abstract but have clearly defined clinical meaning. Does every person have the right to the newest or best version of a particular medicine? Ideally yes, but pragmatically it is not possible. Moreover, advances in drugs, even minor ones, in any of those areas for which companies invariably seek patent protection, is costly and often demands extensive research. Insurance companies argue that they should not have to pay for the added cost of marginally improved drugs and may well not list them in drugs approved for insurance coverage and payment. Providing all desired medicines to all patients is a worthy goal, but unfortunately not a realistic approach or objective to access to medicine. Rather, specific medicines must be identified that set the floor for what should be provided to all patients, no matter in what country they live in. The World Health Organization has established a list of drugs that are essential to the basic health needs of most people, the “Model List of Essential Medicines. These medicines were selected on the basis of Pharma Bio World
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There is no consensus on what constitutes sufficient basic medical care that satisfies a nation’s human rights commitment.
four criteria – (i) the prevalence of the disease which they treat, (ii) evidence of the efficacy of the drug, (iii) evidence of its safety, and (iv) the drug’s comparative cost-effectiveness. The Model List includes very few patentedprotected drugs, other than a number of AIDS drugs. Some organisations have challenged the contents of such a list and claim that the fourth criteria has excluded the most innovative or patented protected drugs from making the Model List. Further, other than national life span tables and the disability-adjusted life expectancy measurement discussed below, there is no objective measurement of what constitutes such essential needs f ro m a q u a l i t y o f , o r p ro d u ct ive , lif e a p p r o a c h . T h e r e a p p e a r s , h o w e v e r, to be a consensus that the pressing or priority health needs of poorer nations at this stage of their development can, barring an emergency, be satisfied by generic drugs and drugs that address neglected diseases, which are neglected for the simple reason that they on the whole affect people in nations which cannot afford the cost of discovering medicines that cure such illnesses. It is important to note, however, that research into drugs to treat neglected diseases, and, accordingly, the availability of those drugs is not sufficient as it is still too charity- or aid-dependent. Such an approach has shown itself in practice a s n o t a s u s t a in a b le f o rm o f f u n d in g over time. Such nations as Thailand and Brazil, which are viewed as middle income nations, do not agree with the standards set by WHO’s essential medicine list and demand a higher level of medical or drug care for their citizens. This contrary view underscores the fact that there is no consensus on what constitutes sufficient
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basic medical care that satisfies a nation’s human rights commitment. Brazil has used the threat of compulsory licensing in its negotiations with pharma companies for access to patented medicines (although so far it has issued only one compulsory license). Thailand has been more active. As discussed by Jamie Feldman in a 2009 article, in 2007 Thailand controversially issued a compulsory license for Plavix, a blood thinner used to treat heart disease that was patented by Sanofi-Aventis and Bristol-Meyers Squibb. In 2008, Thailand also issued compulsory licenses for cancer medications, Sanofi’s Taxotere, Roche/Genentech’s Tarceva, Novartis’ Femara, and Glivec/Gleevec, as discussed in Nicholas Zamiska’s 2008 article in the Wall Street Journal. Heart disease and cancer do not share the same characteristics as other diseases such as AIDS more typically considered appropriate for compulsory licensing. Specifically, although heart disease and cancer can result in death, they are not contagious. Thailand had stepped outside of the type of diseases and essential medicines usually at the center of the access to medicine debate. Consequently, the United States added Thailand to, and has maintained it on, the US “Priority Watch List,” a ranking of serial violators of intellectual property, which also covers patented pharmaceuticals. In turn, the United States has been criticised by non-profit organisations such as Medecins Sans Frontiers for penalising Thailand in this way. Chronic and Debilitating Diseases and National Stability The WHO list seeks to set a floor for essential medicines, but is a universal
list of medicines the standard to judge whether a government has fulfilled its human rights obligations under Article 12 of the Social Covenant? Should medicine to treat chronic, debilitating diseases that are not deadly also be regarded as part of a government’s human rights obligations? Chronic diseases, such as arthritis, are prevalent in developed countries as well as in developing nations. With their physically debilitating effects, they sap a population’s energy and a person’s ability to work productively and to function as a participating citizen. In the view of many human rights activists, medicines to treat chronic debilitating diseases should also be included in any essential medicines list. Many of the drugs for these diseases are still subject to patent protection, and access might well require the imposition of compulsory licensing. Addressing these debilitating, but not deadly diseases, may be necessary for a country to alleviate its poverty issues, to aid its development and spur and grow its economy. Klaus M Leisinger, the recently retired chair of the Novartis Foundation for Sustainable Development, made the following statement in a 2008 article, “Corporate Responsibilities for Access to Medecines”: Poor health is not only a consequence of poverty but also a cause…An individual’s state of health determines their ability to work, his or her labor productivity, and therefore earnings…For poor people, the health of their bodies and minds is a critically important asset – often their only asset. And vice versa: People’s abilities to manage their own lives, to develop their assets, and to learn and make use of their skills and knowledge all depend heavily on their state of health.” An economic argument can be made that access to medicine for debilitating diseases is necessary at every level of the value chain. David Barnard, Professor of Palliative Care and Medical Ethics at the University of Pittsburgh explains in an article, it is essential “to preserve a healthy labor force for the extraction of Pharma Bio World
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measurement where years of life are weighted by health status, and it is commonly used by the WHO. Although not a perfect correlation, one can conclude that populations in nations afflicted with poor health do not have the energy to establish and maintain good governance institutions in their countries. Although not all poor health states are necessarily threats to international peace, it should be of concern that a fair number, including such now well known conflict-torn nations as Afghanistan, Somalia, Sudan and Yemen, are. Accordingly, international political self-interest should also motivate the US and other developed nations to significantly improve the health situation in such nations. But the connection between health and international security is still a little studied or understood concept. natural resources and manufacture of products for purchase by the developed nations, to preserve economically viable markets for the export of the developed nations’ goods, and to protect the populations of developed nations from the spread of dangerous infectious diseases.” Moreover an economically viable nation is normally a more stable and peaceful country. Through this rationale, developed countries as well as companies outside of the pharmaceutical industry have an economic and commercial stake in providing access to medicine in least developed countries. This basic principle also might contribute to understanding why access to medicine h a s b e e n re co g n ise d in t h e le a st controversial instances, such as the push to treat AIDS. The AIDS epidemic created all of the problems mentioned above – unhealthy labor force, economically unviable markets, and the spread of disease. In contrast, cancer and heart disease, for which compulsory licensing was highly controversial, typically do not. This justification for access to medicine does not require that a disease be deadly to demand treatment.
Thus far, we have discussed what medicines a country should provide in order to satisfy its human rights obligations. In the next issue, we turn to the question of who should or will pay for these necessary drugs. Contact: jenik_radon@radonoffices.com
This logic of enlightened self-interest could motivate developed countries and international corporations to recognise t h a t it is c ommerc ially nec es s ary t o prov ide ac c es s to medic ine for ch r onic or debilitating dis eas es that affect large portions of a developing country’s population. Moreover, it is of note that 12 of the 20 nations heading the list of states in the Fund for Peace Failed States Index are also among nations that have the lowest health-adjusted life expectancies (HALE). The HALE is a disability-adjusted
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Keeping a country healthy helps that country develop economically and politically. If a country can reduce its poverty level, the poverty-related causes of disease will also be reduced. Supporting development and reducing the real causes of disease, as opposed to simply providing medicine, will also invariably increase investment and trade because a healthy country is a potential growth market. This growth will benefit other countries that would wish to trade with that country, reduce aid, or that rely on the country’s workforce.
Poor health is not only a consequence of poverty but also a cause.
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T h e r e i s u n m et h e a l t h c a r e n e e d for a single drug with a dual action which single-handedly can control the dyslipidemia and provide glycemic benefits without side-effects.
Pankaj Patel, Chairman and MD, Zydus Cadila in an exclusive interview with Ananya Sen answers all you wanted to know about Lipaglyn. Why was the need for a single molecule to control diabetic hyperlipidemia felt? Why couldn’t the condition be dealt well with two separate drugs each for hyperlipidemia and diabetic control? We can no longer look at dyslipidemia and diabetes in isolation and deal will them separately as research suggests that nearly 90 per cent of all diabetics also suffer from dyslipidemia. There is a gap currently in the treatment of diabetic dyslipidemia. For example PPAR alpha agonists like Fenofibrate which is required in a high dose of 160 mg to control only hypertriglyceridemia and has the drawbacks of renal/liver/muscle toxicity and when combined with statins in conditions where statins alone are not sufficient. The risk of myopathy with this combination increases further. Diabetes control with Metformin alone may work in some, but not in all cases. The addition of sulfonylureas – poses risk of hypoglycemia. The addition of PPAR gama agonists like Pioglitazone can lead to weight-gain, edema and also have other side effects. Similarly, the incretins and insulin also have their drawbacks. So there is unmet healthcare need for a single drug with a dual action which single-handedly can control the dyslipidemia and provide glycemic benefits
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PANKAJ PATEL
On the Lipaglyn Launch……
without side-effects. Lipaglyn addresses this unmet need with its predominant PPAR Alpha and moderate PPAR Gamma action and an excellent safety profile. Lipaglyn is effective in reducing triglyceride levels, LDL cholesterol, total cholesterol and increases HDL Levels. It also provides glycemic benefits like reduction in fasting plasma glucose and HbA1c. The clinical studies have shown that there is no weight gain associated with Lipaglyn, no edema, no cardiovascular adverse events and no potential for liver, kidney and muscle toxicity. Its dual pronged action and excellent safety profile make it a novel drug. Are there any contraindications associated with the drug? Are its metabolites toxic? What is its route of elimination? Lipaglyn has a non-renal route of elimination and is eliminated through the hepato-billary route. The absolute contraindication is hypersensitivity to any component of tab Lipaglyn. Caution in c as e of pregnanc y ( Ca te g o r y C) is advised; Lipaglyn is not meant for the pediatric age group; excretion in breast milk is not known and should be avoided during lactation. It should not be given in combination with PPAR alpha agonists Pharma Bio World
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• The Zydus Group announced a
breakthrough in its research efforts with Lipaglyn (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia.
• Lipaglyn is the first Glitazar to be
approved in the world.
• It is the first NCE discovered and
developed indigenously by an Indian Pharma Company.
• The drug has been approved
for launch in India by the Drug Controller General of India (DCGI)
• Over 80% of all diabetic patients
are estimated to be suffering from diabetic dyslipidemia. There are more than 350 million diabetics globally – so the people suffering from diabetic dyslipidemia could be around 300 million.
diabetes mellitus not controlled by statin therapy alone. Trials are on for its use in Non-Alcoholic Steatohepatitis (NASH) and HIV-induced lipodystrophy.
the Indian market? Which are those?
When will Lipaglyn hit the Indian market?
Have you partnered with other companies to launch your product outside the Indian market?
(fenofibrate - fibrates) or PPAR gama agonists (pioglitazone-TZDs).
We are planning to launch the drug in mid September this year.
What about the issue of carcinogenicity? Has its safety in this respect been proved?
What are your thoughts on the Patent Protection of Lipaglyn?
Tw o - y e a r c a r c i n o g e n i c i t y s t u d y o f Saroglitazar was conducted in Wistar rats. No potential carcinogenic concern for humans was identified, which was further confirmed by a mechanistic study in non-human primates employing molecular biomarkers.
Lipaglyn is fully patent protected. A number of patents have been filed in all countries worldwide under the Patent Cooperation Treaty.
Does the drug show additional indications other than those stated?
In India, Lipaglyn has been priced much lower than any other NCE at ` 25.90. As far as the global pricing is concerned it is too early to discuss this.
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LIPAGLYN has been approved for the treatment of diabetic dyslipidemia and hypertriglyceridemia with Type 2
How are you planning to price the product in India and globally?
Has the drug been filed for approval outside
Two-year carcinogenicity study of Saroglitazar was conducted in Wistar rats. No potential carcinogenic concern for humans was identified.
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We have initiated the process for approvals in various regulated and emerging markets.
Not as yet but we are open to partnerships to market Lipaglyn in global markets. What are your expectations from Lipaglyn in terms of its revenue generation potential? Lipaglyn has the potential to become a blockbuster drug. Currently the market potential of drugs indicated for this therapy is USD 30 billion. We are planning to achieve ` 100 crores in first three years of launch in India. How many new products do you plan to launch by the end of 2020? We have a robust NCE pipeline and hope to bring 2-3 more drugs to the market by 2020. In addition to this we are also developing our vaccines and biologics portfolio.
Pharma Bio World
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Changing Quality and cGMP Environment A Pharma Industry Insight This article discusses the urgent need for the up-gradation of Quality Assurance parameters to meet the stringent FDA norms and cGMP requirements, for the pharma companies to help elevate their product quality and check reputational injury.
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n 2013, the Pharma industry will experience substantial drug patent expirations, with more than 40 brandname products losing patent protection with an estimated value of USD 35 billion in annual sales. In five years the patent expiration and the estimate market opening for the generic manufacturers is expected to increase up to USD 100 billion. While this is one side of the coin – a news of rejoice to the generic players, there’s another side of the coin that is fading out its shine. Now, you ponder what’s making the other side fading! Nowadays, the everyday news about pharmaceutical industry is more about big blockbuster companies failing faces and succumbing to compliance issues, many companies getting clamped down further to legal action against adulterated / m isbranded drug produc ts in the supply chain. Yes, compliance issues. Coping up with the continuously changing, constantly advancing quality environment is one of the challenges that pharma industry is facing today. As a matter of fact, “Comply or face action” is the FDA’s jargon now a days. It is becoming more so evident from the stumbling statistics of number of Warning letters issued out to companies globally by FDA – As of yet approximately 350 warning letters were issued to companies globally this year. Interestingly, FDA has obtained approval from the Indian government in the month of March 2013 to add seven more drug investigators to its Indian offices, which
Chief Scientific Officer Enaltec Labs 20 September 2013
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Dr B V Sivakumar
would increase the number of FDA officials operating from India to 19 from its current head count of 12. Now that enough is said about the compliance issues prevalent in the pharmaceutical industry, what are the actual changes in cGMP environment that has happened and is happening in the industry and how does one upgrade the quality system and effectively monitor its sustenance to stay GMP compliant. Before getting in to what are the current changing landscapes in the quality environment, it is important to introspect on one’s thought and be clarified about what “GMP” is in the eyes of FDA and what exactly is the expectation that FDA has on drug substance/product manufacturers. FDA keeps it simple, when it says cGMP is “establishing strong Quality- management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories that assure the identity, strength, quality, and purity of drug products. Also, it feels that this formal system of controls at a pharmaceutical company, if adequately put to practice, will help prevent instances of contamination, mix-ups, deviations, failures, and errors assuring that drug products meet their quality standards. It’s clear, simple and straight is what you say after reading these lines. Yes it is a CLEAR, SIMPLE
From the primitive ages we know ‘c’ in cGMP stands for ‘Current’, but what actually this ‘c’ means has remained a mystery most of the times. Pharma Bio World
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Here are the big 5s in the league – Lifecycle approach in Process validation, Quality Risk Management, Pharmaceutical Quality Systems, Quality by Design (QbD) and Process Analytical Technology. The need for having quality knowledge right from the design/development stage throughout the lifecycle of a molecule or a drug product has yielded to this transition. Ever since the expectation for the life cycle management has pitched in, the regulations and quality guidelines binding the manufacturers have also taken their course. To get an insight on how the new regulations come up one could understand that, with the need of having better product and process knowledge right from the development stage rose the necessity of evaluating the potential product and process risks, quantifying it and subsequently mitigating it (ICH Q9); the requirement of putting forth life cycle approach to the process validation has resulted in changing the view point about quality and design space from our
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early development milestone; with more emphasis on Life cycle approach and defining quality right from the development phase evolved the concept of QbD, which imbibes concepts from ICH Q8 and ICH Q9. These quality tools which enable manufacturers to enter into the market are reliable while some are still trying to enter into the market early with limited process and product knowledge and later getting outstripped by the advantage of being there early. Let’s have a close look at the latest sensation in the pharmaceutical quality assurance – “Pharmaceutical Quality Systems”. Some of you might wonder as to why it is being called here the latest sensation, while these concepts have been well-known to the industry since decades. You are right; the concepts were known since ages, if one might relate to the concepts of ISO 9001 series, while the recent prominence after FDAs increasing interest towards this has brought it to the lime light. ICH Q10 is not only the latest fad but it also represents the cultural change in the quality environment. Its comprehensive model can be implemented throughout the different stages of a product life cycle (including development) which is putting it favorable in the middle among other GMPs. One might ask, if this puts other GMP regulations to the back seat? No – would be the answer. The harmonised model of a pharmaceutical quality system throughout the lifecycle of a product is intended for integrated use with other applicable GMP regulations and requirements. The quality system elements and management responsibilities described
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and STRAIGHT thought about GMP. Then what’s ‘the’ thing that drives the industry crazy is the little ‘c’ thing to the GMP which makes it cGMP. And yes from the primitive ages we know ‘c’ in cGMP stands for ‘Current’, but what actually this ‘c’ means has remained a mystery most of the times. What is the changing quality landscape in the development and manufacture of drug substance and products? Looking at the trend and regulations in the recent years it is evident the quality approach is moving towards product and process lifecycle management and continual improvement in quality systems. This shift in the quality approach has brought in some quality concepts with increased daily prominence and that one listens to day in day out in the current pharmaceutical quality environment.
The harmonised model of a pharmaceutical quality system throughout the lifecycle of a product is intended for integrated use with other applicable GMP regulations and requirements.
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in this guideline when implemented synergistically with the quality risk management and PAT are intended to encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle. Implementation of the quality tools discussed above facilitates the manufacturer to align with the changing quality environment thereby accomplishing three major objectives: • Achieve product & process realisation. • Establish and maintain a state of control throughout the life cycle. • Facilitate continual improvement. With the increasing quality tools & regulations and the amount of data mining required right from the development stage through the lifecycle of the product, the prominence of statistical analysis of data is growing in to the pharmaceutical sector deliberating to pull in personnel with competencies from other areas like statisticians etc. As regulations and best practices in industry change, monitoring or implementation of these changes into the Quality System will ensure that the organisational structures, processes, procedures and resources used to manufacture pharmaceutical products remain in compliance throughout the product lifecycles; pharmaceutical development, technology transfer, commercial manufacturing and continual improvement. While the regulations are growing and industry is striving to continue producing quality medicines for better patient safety and health, on a positive note, known for making cheaper and equal quality generic versions of expensive well-known drugs, India enjoys about 10 per cent share in the finished-dose product market in the US. Reference US Food and Drug Administration, European Medicines Agency & Forbes Magazine Contact: info@enaltaclabs.co.in Pharma Bio World
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Advanced Cell Screening Technologies Accelerate Drug Discovery Process In this article, the authors review the latest developments in phenotypic assay technologies employed in modern drug discovery.
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he majority of the new “first-inclass” drugs approved in the past 10 years were developed from candidates generated through phenotypic screening, despite the fact that the focus in the industry has been on target-based approaches. With this becoming more apparent, information-rich phenotypic screening strategies have gained strong attention. Despite extensive efforts, drug discovery, particularly in the field of CNS and pain, has seen a number of late-stage failures in recent years. Arguably this is a consequence partially spanning from the lack of predictive in-vitro models. In order to better envisage target engagement and effects of candidate compounds it is important to use relevant cell and tissue models, taking into account the complexity of interactions in both health and disease, as early as possible. Traditionally, cell-based screening in drug discovery has mainly been carried out using recombinant cell lines coupled with homogenous downstream assays, principally due to
cost and convenience. Furthermore, reductionist approaches such as targetbased screening have been widely employed for a variety of reasons, with limited success. Recent observations indicate that phenotypic screening has been more productive in generating “first-in-class” drugs, while an overemphasis on individual targets has been suggested as one of the reasons for the lack of productivity in drug discovery 1. Using phenotypic approaches may lead to the identification of molecules that modify a disease by acting on previously undescribed target(s) or by acting simultaneously on multiple targets. Consequently, there is a large emphasis in the pharmaceutical industry to develop screening strategies with capability to identify phenotypic effects in highly relevant biological models. In particular, there is a strong focus on developing invitro disease models from either native tissue 9,10 or stem cell-derived cultures 2. There is also a need for enabling assay
Mattias Karlsson
Chief Technology Officer Cellectricon
Johan Pihl
Product Manager Cellaxess Platforms Cellectricon
24 September 2013
Advanced Cell Screening Technologies 24-28.indd 24
Cellaxess Elektra Discovery Platform is an automated electrical field manipulation platform which enables in-situ manipulation & monitoring of cell cultures directly in HCA-compatible 96- and 384-well microplates at any cellular developmental stage.
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Because of availability and convenience, immortalised cell lines have traditionally been used in place of more biologically relevant cell models in drug discovery. However, few cell lines, if any, can serve as accurate in-vitro models. Although derived from primary cells, these lines typically consist of immortalised or cancerous cells that divide continuously, suggesting their pattern of gene and protein expression is significantly different from terminally differentiated and functioning cells. In terms of cellular composition and complexity, dissociated primary cultures more closely resemble in-vivo biology than immortalised cell lines. Accordingly, these cellular systems allow evaluation of features and processes that are hard to assess in overexpressed cell lines. Examples include cell morphology and polarisation, energy metabolism, signal transduction, toxicity response and neurotransmitter release. When using native cells or tissue is not practical or possible, iPSC-derived cell models have risen as a highly attractive model for use in drug discovery 2. Although lack of validation is still an issue for many of the models 5, they hold great promise for a variety of disease models in drug discovery 6. Technologies for Phenotypic Screening
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In addition to cell models and systems providing biological relevance, a number
Despite extensive efforts, drug discovery, particularly in the field of CNS and pain, has seen a number of late-stage failures in recent years.
of phenotypic and information-rich screening technologies have emerged that enable accurate interrogation of the more biologically relevant cell models. By far, the most established route today is the shift from homogenous and/or plate reader-based readout assays to various types of high-content based ones. While mostly used as an endpoint assay, highcontent methods allow for detailed analysis of a wide range of cellular phenotypes. Furthermore, the data sets generated by high-content screening allows for refinement of the analysis in a way that is not possible with a single-parametric, endpoint readout.
The available high-content screening instrumentation and analysis methods have evolved immensely since the advent of high-content screening in the 1990s, and there is now instrumentation available ranging from bench-top systems with lampbased wide field illumination to confocal systems with laser-based illumination. A plethora of analysis software options exist to allow the analysis of virtually any cellular phenotype or process, ranging from cell cycle and proliferation, intracellular trafficking and translocation, infection, differentiation, gap junction formation and more 8-10. However, despite the versatility of the current high-content screening platforms, in many cases they lack the ability to apply physiologically relevant stimulus, and this is particularly true in the case of excitable cells. A recent technology combining physiological relevance with an informationrich assay readout is Cellaxess Elektra discovery platform, which enables high-
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Biological Relevance, Primary Cells and IPSC-Derived Disease Models
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Despite the versatility of the current high-content screening platforms, they lack the ability to apply physiologically relevant stimulus.
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technologies 4 that can support screening of this type of sophisticated biology that in general is less amenable to traditional high-throughput methodologies. Ideally, these strategies should be employed early in a project’s lifecycle to add real value to the decision of whether to pursue or eliminate a compound, ultimately translating to considerable cost savings in the drug development business.
throughput in-situ electric field stimulation of adherent cell cultures and tissues in a microplate format. Simultaneous dynamic image-based fluorescence readouts can be employed to monitor the response of the cell culture to electric field exposure in real time. This offers a unique methodology to identify novel modulators of excitable cells for a multitude of diseases in the field of CNS/pain, such as Alzheimer’s disease, Schizophrenia, Parkinson’s and neuropathic pain.
The potential assays include stimulation of native or iPSC-derived cells using specific Electric Field Stimulation (EFS) protocols to characterise the effects of compounds on excitability parameters. One specific example is the pain peripheral sensitisation assay, where primary Dorsal Root Ganglion (DRG) neurons are cultured in microplates and supplemented with nerve growth factor to mimic peripheral sensitisation. The Cellaxess Elektra platform is used to excite the sensory neurons, and the resulting dynamic response assists in the identification of small molecules that have the potential to treat chronic pain 11. On a similar note, Hempel et al has described the development of a highthroughput assay technology for performing assays of synaptic function in primary neurons 7. The system was designed to study synaptic vesicle cycling assays in parallel with high sensitivity, precision, uniformity and reproducibility. By screening libraries of pharmacologically defined compounds on rat forebrain cultures, researchers used this system to identify novel effects of compounds on specific aspects of presynaptic function. As a system for unbiased compound and genomic screening, this technology has significant applications for basic neuroscience research, as well as for the discovery of novel, mechanism-based treatments for central nervous system disorders using a phenotypic approach. Pharma Bio World
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Biologically relevant cell models are a key component for successful phenotypic screening. In this example, induced human pluripotent stems cells differentiated into neurons can serve as a valuable healthy model as well as a disease model. (Image courtesy of the Max Planck Institute for Molecular Biomedicine, Munster, Germany).
Conclusions The development of more biologically relevant cell systems and enabling technology platforms has provided a new toolbox of cell-based assays in drug discovery. Taking into account the realisation that target-based and/or reductionist screening techniques may not provide the high quality candidates needed to drive the development of new drugs has led to a significant shift in screening towards these innovative new technologies, and cell-based phenotypic screens are regularly being employed alongside traditional target-based screening 4. Interestingly, phenotypic screens may also allow rescreening of previously rejected compounds tested against specific targets, perhaps revealing a new and unexpected function.
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In time, phenotypic screening technologies are sure to improve the early stages of the drug discovery process - in the form of more and higher quality drug candidates, while also leading towards an overall more efficient drug discovery process in the longer term.
4. Kotz J. Phenotypic screening, take two. SciBX 5, doi:10.1038/scibx.2012.380 (2012). 5. Saha, K. & Jaenisch, R. Technical Challenges in Using Human Induced Pluripotent Stem Cells to Model Disease. Cell Stem Cell 5, 584-595 (2009). 6. Devine MJ et al. Parkinson's disease induced pluripotent stem cells with triplication of the a-synuclein locus. Nature Communications 23, 440-449 (2011). 7. Hempel, C. M. et al. A System for Performing High Throughput Assays of Synaptic Function. PLoS ONE 6, e25999 EP - (2011). 8. Bickle M. The beautiful cell: high-content screening in drug discovery. Analytical and Bioanalytical Chemistry 398, 219-226 (2010). 9. Lie M, Grover M & Whitlon DS. Accelerated neurite growth from spiral ganglion neurons exposed to the Rho kinase inhibitor H-1152. Neuroscience 169, 855-862 (2010). 10. Blackmore MG et al. High content screening of cortical neurons identifies novel regulators of axon growth. Molecular and Cellular Neuroscience 44, 43-54 (2010). 11. Karila P. in 6 th Annual Targeting Pain with Novel Therapeutics (Cambridge Healthtech Institute, 2013). Contact: mattias.karlsson@cellectricon.se
References 1. Swinney, D. C. & Anthony, J. How were new medicines discovered? Nature Reviews Drug Discovery 10, 507-519 (2011). 2. Chambers SM et al. Combined small-molecule inhibition accelerates developmental timing and converts human pluripotent stem cells into nociceptors. Nature Biotechnology 30, 715-720 (2012). 3. Elliott, N. T. & Yuan, F. A review of threedimensional in vitro tissue models for drug discovery and transport studies. Journal of Pharmaceutical Sciences 100, 59-74 (2011).
The development of more biologically relevant cell systems and enabling technology platforms has provided a new toolbox of cell-based assays in drug discovery.
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Case Study: Ipca Chooses Seclore Filesecure on the Cloud to Protect Critical IP Sharing of data internally within the organisation a s a ls o out s i de t he company with customers and partners and at the same time ensuring their security is a huge concern with most pharmaceutical companies today.
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harmaceutical companies possess a lot of confidential data pertaining to R&D, ADL, Specifications, Process, Marketing strategy etc. which need to be secured in order to prevent leakage of information which may have calamitous impact on their business. Challenges • To implement an information security solution, which would allow Ipca to send information to its customers yet protect information from others • To educate Ipca’s customers and internal users as well as address inherent resistance to new work processes and technology Information Rights Management (IRM) as a Solution In order to ease the complexity involved in securing information, Seclore provides all the functionalities to protect information including sharing of documents with specific users, imposing limitations over the time
period to access data, restriction on copying or forwarding information, providing audit trails of different actions performed by the user to whom this document access has been provided thus preventing data leakage even through authorised users. Moreover “Seclore” functions with any format of the document and provides with a backup plan for retrieving the data in an emergency in the absence of the authorised personnel since the administrator will have rights to transfer the ownership. After looking at various options for securing external collaboration such as encryption and data rooms, Ipca selects Information Rights Management (IRM) as the technology which will implement security controls while allowing collaboration with external agencies. “IRM was the only option for us to achieve two mutually conflicting goals ie, minimal change in existing information workflows and complete security of information throughout its lifecycle within or outside the enterprise,” Said Ashok Nayak, the
Ashok B Nayak
General Manager, Information Technology Ipca Laboratories Limited 30 September 2013
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General Manager (Information Technology) of Ipca. Ipca Chooses Seclore FileSecure Ipca considered various on-premise offerings including Microsoft RMS, EMC and Seclore FileSecure but finally decided on the cloud hosted offering of Seclore. “We chose Seclore because it is an allin-one solution which allows us to use the power of IRM without worrying about formats, applications and whether people were within or outside of the enterprise. Using the cloud service allows us to go
Conclusion
live almost overnight without worrying about deploying or maintaining systems ourselves. We also have an option to on-premise the whole system later if we want to,” said Ashok Nayak, the General Manager (Information Technology) of Ipca.
Ipca is presently using Seclore’s hosted offering to protect critical IP and product dossiers containing the entire process of manufacturing a drug. The product dossiers go through an internal process of creation and sanitisation before they are circulated to external agencies. While there are no known cases of data breaches, the IRM system helps the personnel to “sleep better” knowing that their most confidential information is being persistently protected.
IRM technology works by providing information-centric security which can control WHO can access information, WHAT can each person do, WHEN and from WHERE. These controls are applicable within the enterprise and even when information goes to “uncontrolled” environments such as personal devices, cloud applications and external stakeholders.
Contact: ashok.nayak@ipca.com
PBW Marketing Initiative
Ensuring Product Traceability, Brand Protection, and Process Control
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anufacturers of certain consumer goods must have systems in place to provide a trail of information that follows each item through the supply chain. To ensure product safety and efficient recalls, producers must be able to quickly identify and locate potentially faulty items in the supply chain that could pose a hazard to consumers.
To achieve this, many companies are implementing 2-D barcodes, vision systems, and image-based ID readers as key components in a simple yet robust product traceability system. Data Matrix has been adopted as standard in many applications because it allows the storage of more information such as manufacturer, product ID, lot number, expiry and even a unique serial number on virtually any finished good. Brand Protection Serial number aggregation for supply chain security and product authentication at the point of sale can help prevent counterfeiting, diversion and sale of
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Incorrectly facing bottles are detected by the vision sensor which signals an actuator mechanism to rotate the bottle to the correct orientation.
product through unauthorised channels. These applications generally seek itemlevel serialisation on every package and Data Matrix has been adopted as standard. In addition to improving material handling and logistics efficiency and flexibility, product quality and yield, and package safety and integrity, machine vision can also be implemented on the processing side to reduce scrap, improve productivity and quality control, as well as enhance brand image. For example, vision systems can sort food and beverage products by color or shape. It can detect defects, verify proper assembly, detect fill levels, count, and provide guidance for robotic pick and place or palletising operations to achieve improved manufacturing and packaging flexibility. Another application is orienting bottles based on shape when they enter the machine in random positions. Machine vision can identify correctly facing bottles and allow them pass through.
Process Control and Supply Chain Management The better and more precise the track and trace system, the faster you can identify and resolve problems. If profit margins are narrow, reduced manufacturing and supply chain costs can often be the difference between profit and loss. Traceability: • • • •
Improves management of work in process Reduces inventory Optimises availability and use of production tools Minimises distribution of nonconforming products For further information, please contact: Sunil Vaggu Cognex Sensors India Pvt. Ltd vaggu.sunil@cognex.com 9881466003
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10/1/2013 5:28:48 PM
Pharma Seals Made Safer with Butyl Rubber This article focuses on the need for use of butyl rubber over natural ubber for Pharma closures or stoppers in order to prevent the unknown and unwanted reactions of natural rubber with active ingredients in the medicine.
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harmaceutical seals and closures need to be impermeable i.e. must not allow migration of materials in either direction, must be elastic and also chemically inert ie must not release particles after puncture. B u t y l a n d e v e n b e t t e r, H a l o - B u t y l rubber meets these requirements, being resistant to heat, ozone, radiation acids/ alkali, water, gas and moisture vapor. More than 90 per cent of pharmaceutical st o ppers produc ed today (globally ) a re bas ed on buty l and halogenated butyl rubbers (Chloro- and Bromo-Butyl rubber) because these polymers provide the best balance of properties for this application. Butyl rubber is a polymer with unique physical and chemical properties like High purity (approximately 99 per cent Isobutylene), high saturation and high impermeability to gas and moisture. The Vulcanisates made of butyl rubber have extremely low permeability to gases, vapors and moisture, good weathering,
ozone, hot air and chemicals (basic & acidic), leading to high stability (ie low reactivity and inertness). Manufacture of Butyl Rubber The raw materials for making butyl rubber are isobutylene and isoprene. These two components are polymerised at -100°C, the temperature at which butyl rubber forms. In a further step, Halo-Butyl rubber – a premium rubber product, is obtained by means of halogenation, the reaction with chlorine or bromine. Only a few manufacturers worldwide have mastered this complex process and LANXESS has recently invested in a state-of-the-art plant in Singapore, apart from those existing in Germany and Canada. Benefits In India, natural rubber has historically been in use for several pharmaceutical applications like closures/stoppers in medicine bottles, injection vials/plungers
Rupesh Shah
Head of Business Unit - Butyl Rubber LANXESS 34 ď‚ƒSeptember 2013
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In China, according to the State Food and Drug Administration regulations, starting from 1st January 2005, all medical stoppers, infusion, oral drugs, including a variety of dosage forms are no longer allowed to have the traditional natural rubber stoppers as packaging material and has been replaced by butyl rubber. Unfortunately in India, there’s no such legislation which controls the use of natural rubber in pharmaceutical applications. In 1998, the Food and Drug Administration (FDA) initiated labeling of medical devices made from natural rubber latex; since that time substantial progress has been made in identifying latex-free alternatives. However, the rubber stoppers commonly found in pharmaceutical vial closures are exempt from FDA labeling requirements.
for prefilled syringes, droppers, seals for aerosol gaskets and other closures in various pharmaceutical devices. However, due to its high permeability and high reactivity (due to high unsaturation even after curing), natural rubber is deemed unfit for pharmaceutical applications. To make such rubber stable, several additives (like Sulphur as curatives) are used, which in turn could react with the medicinal content. When in contact with the drugs, the proteins and impurities in natural rubber leach into the contents of the bottles or syringes, rendering the contents unfit for use. The ideal alternatives are butyl rubber and halo butyl rubber, which are used worldwide for pharmaceutical applications due to their low permeability to air and moisture, high purity of polymer and inertness after the curing process. It is also increasingly gaining acceptance in India. Butyl rubber especially halo butyl rubber, has much lesser curatives in its formulation and therefore, causes far less contamination and the leachables are practically negligible, making it one of the safest polymers for pharmaceutical applications. Also since there is no natural rubber latex used in the manufacture of butyl rubber, there are no possibilities of allergies from latex. 36 ď‚ƒSeptember 2013
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Butyl or halo butyl rubber stoppers are used in several Pharmaceutical applications like infusion containers/ pumps, injection vials, blood sampling vials, dental anesthetics, Butyl plunger seals, pre-filled syringes, insulin containers, aerosol gaskets in inhaler seals etc. However, it can be used in any application that requires less reactivity and impermeability to gas & moisture Regulatory Requirements for Drug Closures The compatibility with pharmaceuticals of all compounds used to make rubber closures must be checked before use. The properties must comply with the international regulations such as the Food and Drug Administration (FDA) in the US and any similar local regulatory requirements. The selection of rubber and the compounding ingredients must be based on the compatibility with the various national pharmacopeia and standards of specific pharmaceutical closures. In different countries, the pharmacopeia has different requirements, however, every pharmacopeia has guidelines for some standard physical tests like sealing (tightness), self - sealing, permeability to water vapor; chemical tests for reducing substances, residue of evaporation, chlorides, compatibility and biological tests for aspects like toxicity and cytotoxicity.
In India, the pharmaceutical industry is aware of this but there's no law that prohibits cork/stopper manufacturers from doing so. In the absence of a definite regulation in this regard, it will be ideal if the pharmaceutical manufacturers demand high quality rubber in applications that can otherwise put lives at risk. Most of the rubber stopper manufacturers in India are already aware of the implications of the natural rubber and they already recommend use of advanced polymers like halo butyl rubber. However, at the consumer level, there may be a lack of awareness on this topic. It is only a matter of time that consciousness will increase on such issues. Future Trends Butyl or halo butyl rubber is definitely the way to go for most of the pharmaceutical applications for the reasons discussed above and also given the stringent regulations evolving in several countries. It is just a matter of time when Indian consumers, regulatory authorities and Pharmaceutical companies would also insist only for the safest polymers. Also with many leading global rubber closure manufacturers now setting up plants in India, there will be a rise in the usage of regular and halo butyl rubber over, natural rubber in India. Contact: garima@mutualpr.com Pharma Bio World
10/1/2013 6:45:50 PM
Who’s Who th 14 Edition
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market research
The Fall of the Rupee and its Impact on Pharma Frost & Sullivan deliberates on the impact of the depreciating rupee on the Indian Pharmaceutical Industry.
T h e R e p o rt o f t h e Wo rkin g Gro u p on Drugs and Pharmaceuticals Industry for the 12 th five year plan has predicted the growth rate of the Indian pharmaceuticals industry to reach 18 per cent by 2016-2017. The domestic as well as international markets have been taken into account, each contributing a projected growth rate of 21 per cent and 16 per cent, respectively. The Indian p h a rm a c e u t i c a ls in d u st ry is e xp o rt oriented, with exports contributing nearly 50 per cent of revenues. Exports by Indian pharma companies contribute a major chunk of the global generics market. In 2012, India alone
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FOREX Loans (USD Million)
Aurobindo Pharma Limited
600
Cadila Healthcare
150
Dr. Reddy's
200
Glenmark
85
Ipca Labs
80
Lupin
450
Ranbaxy
112
Torrent Pharma
80
Exhibit 1: FOREX loans for major pharmaceutical companies as of June 2013 Source: Capital IQ & Frost & Sullivan Analysis
contributed exports worth USD 15 billion to the global generics market and almost 40 per cent of exports were to the US alone. Hence, Rupee depreciation against the Dollar will result in cash inflows for pharmaceutical companies that derive a significant part of their revenues from the US. However, the effect of increased US sales is not a cut from the same cloth; the gains are also dependent on the hedging policy of companies. Firms, which undertook forward contracts of hedging their sales revenues so as to insulate themselves from currency fluctuations, will not benefit much from Rupee depreciation.
Rupee depreciation against the Dollar will result in cash inflows for pharmaceutical companies that derive a significant part of their revenues from the US.
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Research Analyst, Business & Financial Services, Healthcare Frost & Sullivan
Company
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he Rupee which has already experienced a gradual fall since the beginning of 2013, spiraled out of control between June and August 2013, when it depreciated over 24 per cent from ` 55 to ` 68 per USD. High current account deficit of 4.9 per cent of GDP (highest after US and UK), policy paralysis, political uncertainty, and expected election year expenditures are the key reasons attributed to the fall of the Rupee. With Rupee expected to fall further, its impact on the Indian pharmaceutical industry is cut both ways.
Dr Saneesh Edacherian
Also, pharmaceutical firms that have hedged more than 40 per cent of their foreign currency transactions will not gain much due to the falling Rupee. Companies like Sun Pharma, CIPLA and Divi’s Labs realised quick gains compared to other companies because of their favorable hedging policy. Exports of Divi’s Labs alone contributed to more than 90 per cent of its revenue, which was mainly left unhedged. Dr Reddy's has hedged outstanding cash flows up to USD 480 million and Sun Pharma has hedged its exports against the Dollar for the next one year. Profitability of companies is also affected by loans they owe in foreign currency. Higher Dollar conversion rate invariably results in higher interest and loan repayments. The additional debt burden adversely affects their profitability. Aurobindo Sciences,
Pharma, Glenmark,
Jubilant Shasun,
Life and
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The impact of Rupee depreciation on Indian pharmaceuticals industry is not an open-and-shut case and it can be only assessed towards the end of second half of 2013, after the results are declared.
Ranbaxy have a significant portion of their debt in foreign currency. So export gains will be partially offset by debt and interest payments. If these companies had not hedged their loans with fixed dollar rates they would have been liable to pay back their loans at a higher dollar conversion rate than the rates at which they acquired the loan.
materials for manufacturing purposes. India’s imports of Active Pharmaceutical Ingredients (API) and drug intermediates increased by 38 per cent from USD 2.9 billion in 2011, to USD 4.7 billion in 2012. Imports increased primarily to mitigate the risks of reduced margins due to the new pricing policy. However, rupee depreciation will increase the cost
Exhibit 2: Increase in Spot exchange rate of Currency against US dollar between August 2012 and August 2013 Source: www.TradingEconomics.com
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The Indian pharmaceutical industry imports more than 75 per cent of raw
of imported raw materials. Though a major part of the import is from China, payments are made in Dollars, which increases the cash burden. Small and mid-cap companies will be more affected by the increasing cost of raw materials than the major players who have a higher export component in their revenue. Over the years, leading participants of the Indian Pharmaceuticals industry have established a strong foothold in other fast growing economies such as South Africa, Russia, Brazil, Mexico, and Southeast
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Small and mid-cap companies, which primarily cater to the domestic market, are already hit by increasing inflation, capital expenditure, and raw material costs. The impact of New National Pharmaceutical Pricing policy will further reduce their profit margins. This policy has brought in around 348 drugs under the essential drugs category, and these include almost 40 per cent of the total drugs in the market.
Small and mid-cap companies, which primarily cater to the domestic market, are already hit by increasing inflation, capital expenditure, and raw material costs.
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Asian countries. Indian companies have not only profited from increasing revenue from these emerging markets but have also invested considerably in manufacturing facilities in these countries. Dr Reddy’s in Russia, Lupin in Japan and Torrent in Brazil are a few examples of companies that have a significant presence in other emerging economies. Currency depreciation against the USD is not only a phenomenon in India but also in other emerging economies such as Brazil, Russia, Indonesia, South Africa, etc. As evident from Exhibit 2, spot exchange rates of currencies of emerging economies against USD have increased between August 2012 and August 2013. Repercussion of currency devaluation in other emerging economies is expected to reduce revenues from emerging economies. Rupee depreciation will also compel importers to re-negotiate Dollar prices of products. To benefit from the rupee fall. The fall in the Rupee is also expected to impact foreign investments of major market participants. Increased spot exchange rates will escalate investment costs; hence, major mergers and acquisitions (M&A) deals might be deferred or even called - off. Cash outflows for the first half of 2013 decreased to USD 5.6 billion as compared to USD 13.0 billion in the first half of 2012. Sun Pharmaceutical’s expected acquisition of Swedish Meda Pharmaceuticals in June was shelved. The key reason behind this decision was the increased cost incurred due to Rupee depreciation. The impact of Rupee depreciation on Indian pharmaceuticals industry is not an open-and-shut case and it can be only assessed towards the end of second half of 2013, after the results are declared. In a nutshell, though Rupee depreciation increases revenue from exports, the gains will be neutralised by debt and interest payments, domestic market woes due to pricing policy, and reduced profits from emerging economies. Contact: akshatam@frost.com Pharma Bio World
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news features
Thalidomide Tragedy Revisited Are the lessons learnt from the Thalidomide Tragedy relevant in today’s time? Finds out Ananya Sen in an interaction with Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe Private Limited
Ananya Sen
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he unforgettable disaster of the Thalidomide Tragedy of the1960’s is arguably one of the largest catastrophes recorded in the history of drug discovery. Fifty years after this calamity the global pharma scenario has undergone a radical transition today. The regulatory norms starting from manufacturing of the drugs, carrying out their clinical trials to approving them for their launch, the pharma industry has come a long way. The need for stringent Pharmacovigilance study today can’t be overstated. Emphasising on the significance of Pharmacovigilance, Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe Private Limited, a Pharmacovigilance Consulting & Services company calls it “an inseparable part of all phases of drug development”. He further adds saying that with the withdrawal of popular drugs from various markets across the globe making news in the media, the pharmaceutical industry and regulatory agencies have started waking up to the challenge. Ever since the thalidomide tragedy occurred 50 years ago, the significance
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of pharmacovigilance has been felt throughout the world, particularly in the developed countries. With most of today's drugs being developed and tested in wellregulated markets before being approved for marketing globally, a catastrophe of the magnitude and scale of the thalidomide tragedy is unlikely. India's drug regulatory scenario is in the process of an overhaul and it is expected that we will have a stable and comprehensive pharmacovigilance system in the country in a few years from now. Since Indian regulators seldom face the situation wherein they have to make a decision on approving or rejecting new drugs which have not been hitherto approved in countries with mature pharmacovigilance systems, this is not a major problem at the moment. Added to these facts is that pharmacovigilance as a science has evolved a lot and almost all of the international and Indian innovator companies now have adequate internal control systems for ensuring that all precautions for patient safety are in place. However, all stakeholders of Indian pharmacovigilance need to gear up to cope with the fast-evolving global drug regulations. Today when the industry is well equipped to conduct clinical trials both technically and on the regulatory front, the suspected
unexpected adverse events definitely do not go unnoticed. But are they ever revealed to the world? To this Dr Vijay answers that for certain drugs, especially the recently approved ones, post-marketing surveillance studies are done across the world and these studies may unearth unusual outcomes occurring with the usage of the said drugs. He continues that, not all suspected adverse reactions are reported either to regulatory agencies or to the concerned pharmaceutical companies. Therefore, it may not be always possible to know even of significant harm caused by medications which are already available in the market, unless a huge population is exposed to the drug and reports of specific adverse events with the said drug emerge from various parts of the world. However, at this moment, India is yet to catch up with its global counterparts in these aspects. According to the Schedule Y of the Drugs & Cosmetics Act, new drugs should be closely monitored for their clinical safety once they are marketed. Periodic Safety Update Reports (PSURs) containing all relevant new safety information from appropriate sources in relation to the patient exposure, summarising the market authorization status in different countries and any significant variations related to safety are necessitated to be submitted to the Central
Thalidomide was initially available in 1957 over the counter in Germany as an effective sedative which was exceptionally well tolerated and was not habit-forming. It was advertised to be “completely safe” for everyone, including mother and child, “even during pregnancy”. Discovering that thalidomide worked well to ease morning sickness, Australian obstetrician Dr. William McBride started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. What followed this is familiar to all. The drug interfered with the babies' normal development, causing many of them to be born with phocomelia, a congenital disorder involving malformation of the limbs. Hundreds of babies in Germany were reported to have been affected by thalidomide, ultimately compelling the manufacturers of the drug to finally stop distribution within Germany.At about this time, when the severe effects of this drug were discovered the then US President John F. Kennedy and the whole of America began praising FDA inspector Dr Frances Kelsey, who was earlier severely criticized and pressurized by pharmaceutical companies and FDA supervisors for not approving the drug in the United States. Kelsey found the data on the drug’s safety and effectiveness incomplete and insufficient.
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General of India (DCGI) mandates the submission of Periodic Safety Update Reports (PSURs) for new drugs but not all pharmaceutical companies are compliant. Pharmacologically, idiosyncratic reactions with drugs are also adverse events and the same protocol is to be followed for them too.
Drugs Standard Control Organisation. The PSURs have to indicate whether changes should be made to product information in order to optimise the use of the product in India. New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.
Apart from PSURs, there are some more post-marketing pharmacovigilance activities that have to be carried out in order to be on par with the global post-marketing drug safety regulations. Unfortunately, there aren’t any specific guidelines for post-marketing pharmacovigilance in India, as the Schedule Y focuses more on Clinical Trial Safety. “Not only framing stringent guidelines but implementing them with force is what is expected of our regulatory authorities in the near future“, asserts Dr Vijay. While not all pharmaceutical are compliant with these at the moment, the future hold promise, as they have
“
companies regulations seems to resulted in
Thalidomide victim
encouraging many Indian drug companies to launch their own pharmacovigilance systems or approach pharmacovigilance consultants and service-providers to set up and maintain the drug safety systems for their marketed products. The system of reporting adverse events/ idiosyncratic reactions periodically in India today is changing. The Pharmacovigilance Programme of India (PvPI) which was initiated in July 2010 by the CDSCO, in collaboration with the Indian Pharmacopoeia Commission is a huge step forward in the right direction for collating Indian drug safety data. However, it is currently restricted to the approved medical college hospitals in India, public health programmes, and autonomous institutes like the Indian Council of Medical Research (ICMR). Dr Vijay conveys that apart from PvPI, some Indian pharmaceutical companies also receive adverse events, process them and report them to the CDSCO. The CDSCO headed by the Drug Controller
“
Commenting on post marketing surveillance that is mandated by Schedule Y under the D & C Act, Dr Vijay points out that PSURs are required to be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years – the PSURs need to be submitted annually. PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period. However, all cases involving serious unexpected adverse reactions must be reported to the licensing authority within 15 days of initial receipt of the information by the applicant. If marketing of the new drug is delayed by the applicant after obtaining approval to market, such data will have to be provided on the deferred basis beginning from the time the new drug is marketed.
Although off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, nonetheless it carries health risks and differences in legal liability.
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Thalidomide that was primarily available as a mild sedative was later being used to relieve morning sickness in pregnant women. How safe is off label use of drugs? Although off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, nonetheless it carries health risks and differences in legal liability. “Since our pharmacovigilance system is still emerging, I personally feel, that regulating off-label prescriptions is something that can be done in the next step, as we are yet to fulfill the basic expectations that one would have of a pharmacovigilance system”, opines Dr Vijay. “Generally, prescribing physicians decide to use a drug off-label in the best interests of their patients and based on their confidence levels of using particular drugs in selected patients with specific conditions, especially when an alternative approved therapy is unsuitable, unavailable, unaffordable or inaccessible. Hence, physicians usually take the liability for adverse outcomes of off-label use of drugs, if any”, he concludes. In an era when the concept of teratogenigicity was not even well established, Dr Kelsey successfully prevented the entry of the drug in the American market. She could have easily approved the drug which was being used in over forty countries. But what prompted her for its denial to approval? Kelsey felt, “There was something a little different about this one so it seemed better to be safe and sure.“ The need to not only conduct pharmacovilgance and drug safety studies but also enforce strict regulatory norms has been greatly felt today. It is for this reason that these should not be seen as a road blocks to newer drug approvals, but as prerequisites before approving a drug to guarantee the safety of patients. Pharma Bio World
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pharma news OPPI Seminar on Challenges and Future Roadmap for Healthcare Access The Organisation of Pharmaceutical Producers of India (OPPI), the premier association of research and innovation driven pharmaceutical companies in India, held a seminar in the city, titled “Access to Healthcare – Challenges and the Way Forward.” The event brought together distinguished professionals, acclaimed experts, policy makers and other stakeholders from the Indian healthcare industry and allied sectors to share their vision and key insights about how the overall status of healthcare access can be improved in the country. In his welcome address, Tapan Ray, Director General, OPPI, deliberated upon the healthcare consumption trends in India. Setting the agenda for the day, he stated: “Access to healthcare is a subject of immense significance for India particularly with the increasing incidences of new diseases in the country, from cancer and diabetes to chronic kidney disease and cardiovascular diseases. We need to ensure that Indians not only get prompt and easy physical access to healthcare facilities but also that they can also afford the treatment. This can only be done by reducing the out-ofpocket healthcare expenditure in India, which is currently as high as 75 per cent. The government needs to move quickly on plans for universal healthcare access and renew its focus on public health infrastructure and the healthcare delivery system.” A recent ground-breaking study “Understanding Healthcare Access in India – What is the Current State?” by the IMS Institute for Healthcare Informatics has revealed that the out-of-pocket expenditure for both outpatient and inpatient treatments in the country can be reduced by as much as 45 per cent by addressing four critical dimensions of healthcare access: (i) Physical accessibility and location of healthcare facilities; (ii) Availability and capacity of needed resources; (iii) Quality and functionality of service required for patient treatment; (iv) Affordability of treatment relative to a patient’s income.
Almac Discovery and Queen’s Enter into New Cancer Drug Discovery Partnership A new 13 million pound partnership to accelerate cancer-focused drug discovery in Northern Ireland has been launched by Enterprise Minister Arlene Foster MLA. As part of the project, Queen’s and Almac Discovery have announced the scheduling of a phase one clinical trial for ovarian cancer, involving the first novel cancer drug fully developed in Northern Ireland. Involving up to 60 ovarian cancer patients, the drug being trialled has been created as a result of an earlier collaboration between Almac Discovery and Professor Tracy Robson from the School of Pharmacy at Queen’s. 46 September 2013
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Explaining about the trial, Professor Robson said: “This latest trial involves a new treatment for cancer known as ALM201, which rather than attacking tumours directly, prevents the growth of new blood vessels in tumours, starving them of oxygen and nutrients and thereby preventing their growth. It targets tumours by an entirely different pathway to those treatments currently approved.” Alan Armstrong, CEO of Almac added: “Bringing new treatments to patients is a complex process. The announcement of a new clinical trial, which is the result of a previous partnership between Almac and Queen’s School of Pharmacy, is a timely illustration of how collaboration between the University and industry is already creating novel approaches to cancer therapy which have a very real chance of helping patients.” At the event, Enterprise Minister Arlene Foster, said: “This significant investment in research and development will enhance collaboration between academia and industry. This will ensure the investment is maximised, that research is effectively commercialised and that ultimately, enhanced treatment solutions are made available to cancer patients. “The fact that Almac and Queen’s are engaged in such groundbreaking research here in Northern Ireland is something that we should be extremely proud of. It will reinforce our position as a leader in research and development for the health and life sciences sector.” It was also announced today that a new CCRCB/Almac Discovery joint programme in Cancer Drug Discovery will bring researchers from Queen’s University Belfast’s Centre for Cancer Research and Cell Biology (CCRCB) and scientists from Almac Discovery together to translate research discoveries into treatments for patients.
Breckenridge Buys Certain Cypress Products from Pernix Breckenridge Pharmaceutical, Inc announced that it has completed its acquisition of certain Cypress Pharmaceutical, Inc product assets from Pernix Therapeutics. The assets include 11 Abbreviated New Drug Applications (ANDAs) filed with the FDA, certain ANDAs in various stages of development, as well as 6 already-approved and marketed products The company will begin distributing these Cypress-labeled products immediately, and the next phase will be converting these products to the Breckenridge label. Customers have received detailed notices on the affected products and changes in ordering policies. The assets include various unique dosage forms, such as ophthalmic, nasal spray, oral solution, syrup, and powder products, in addition to solid-oral products. Breckenridge will begin marketing the approved products and continue to prosecute those ANDAs currently filed and pending with FDA. “Breckenridge is excited to expand our current portfolio, as well as our R&D pipeline. The Cypress assets are a natural fit to and complement the Breckenridge portfolio.” stated Larry Lapila, Executive Vice President of Breckenridge Pharmaceutical, Inc. Pharma Bio World
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Piramal to Invest USD 11 Million in Onglyza Achieves Primary Safety Hormonal Healthcare Production Endpoint Piramal Healthcare announced that it is to invest 11 million USD at its Morpeth, UK facility to triple the production capacity for hormonal products, including contraceptive pills and hormone replacement therapies. The expansion, which has been commissioned in response to customer demand and new business gains, will see the Morpeth site’s production capacity increase by around 2 billion tablets per annum. Work on the new suite, which will house formulation, packaging coating and tableting equipment, will commence at the end of 2013, with mechanical completion anticipated within 12 months and full operations expected to begin following a 6 month validation period. This latest investment follows Piramal Healthcare’s recent announcement that it is to invest 2.5 million USD at its FDA approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing suites, from clinical phase to commercial grade, in response to customer demand. The upgrade will give Piramal two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site. “The production of hormonal products is a highly specialised, niche area,” commented Piramal Enterprises’ Executive Director and COO, Vijay Shah. “The Morpeth facility is our Centre of Excellence for these products and this expansion will greatly enhance our offer and potential for growth in this space. The hormonal sector currently represents a USD 11 billion market globally and is growing at a pace of 4 to 5 per cent annually. With major competition limited to a small number of CMOs in Europe, Piramal sees major opportunities for growth in this area given our vast experience in this field, which spans more than 40 years.” With this expansion, Piramal aims to be one of the largest contract manufacturers in this niche segment which, as per the USFDA and MHRA regulations, requires a dedicated manufacturing facility for the handling of high potent molecules. The 13,000 sq ft Morpeth facility also houses Active Pharmaceutical Ingredient (API) production, general solid formulation production, and a range of clinical trial supply and research facilities, and was acquired by Piramal from Pfizer in 2006. Piramal Healthcare provides Late Phase API services on an integrated manufacturing model across North America, Europe and Asia. All its facilities manufacturing commercial phase APIs have been GMP certified and possess API finishing facilities. Piramal has a successful performance record of over 40 years for the supply of APIs to the US and European markets from its facilities located in Canada, India and the UK. With a reactor volume exceeding 500 KL, including pilot plants and multi-purpose plants, Piramal Healthcare is capable of executing the extensive API requirements of its client base. Pharma Bio World
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AstraZeneca and Bristol-Myers Squibb announced the full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. In this study, Onglyza (saxagliptin) met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal Myocardial Infarction (MI) or non-fatal ischaemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycaemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses. The major secondary composite endpoint of cardiovascular death, nonfatal MI, non-fatal ischaemic stroke or hospitalisation for heart failure, unstable angina or coronary revascularisation was balanced across the two arms. One component of the composite secondary endpoint, hospitalisation for heart failure, occurred more in the Onglyza group compared to placebo. Rates of pancreatitis were low and balanced between Onglyza and placebo. Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza group than in the placebo group. More patients in the Onglyza group reported at least one hypoglycaemic event compared to placebo. Results were presented today during a Hot Line session at the ESC Congress 2013 in Amsterdam, Netherlands, and published in The New England Journal of Medicine. “Given the correlation between diabetes and cardiovascular complications, there is a need for thorough assessments of the cardiovascular risks among therapies that improve glycaemic control,” said Deepak L Bhatt, MD, MPH, Senior Investigator of the TIMI Study Group, Brigham and Women’s Hospital, and a Principal Investigator for the trial.
New State-of-art Lab Opened at IIT Chennai Science Park Agilent Technologies India Pvt Ltd announced its collaboration with Trivitron Healthcare to establish a world class Partner Lab situated within the campus of IIT Chennai Science Park. Newer technologies are getting introduced into the field of clinical diagnostics in healthcare segment and more recently there has been a keen interest in using high end analytical technologies to diagnose the disease more accurately, rapidly and with enhanced sensitivity in comparison to the current day solutions. As a part of this association, the Partner lab is equipped with some of the high end technologies like UHPLC, LC MS/MS, qPCR’s from Agilent, through which Trivitron aims to develop end to end solutions using these analytical platforms in a cost effective way making them accessible and affordable for clinical testing markets in emerging countries like India. September 2013 47
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Mettler Toledo Thornton Expands Conductivity Sensor Portfolio Mettler Toledo Thornton, a leading provider of pure water analytical measurement solutions, announces the expansion of its conductivity sensor portfolio with the UniCond 4-E digital sensors. The new fourelectrode sensors have been designed to provide highly accurate measurement across a very wide range: a single UniCond 4-E measures from pure potable water to acid or base concentrations. Applications for the UniCond 4-E series include Clean-in-Place and desalination processes, deionisation regeneration, industrial processing, and wastewater treatment. Analog conductivity sensors are prone to signal degradation caused by sensor-to-transmitter cable resistance and capacitance. METTLER TOLEDO Thornton has solved this issue by incorporating technology into the UniCond sensors that converts the analog signal into a robust and reliable digital signal. In addition, the sensors contain METTLER TOLEDO’s Intelligent Sensor Management (ISM) concept. Features of ISM include Plug and Measure start up at the measurement point and sensor diagnostics for proactive maintenance. In addition, the UniCond 4-E can be calibrated without extraction from the process. This makes the sensors compliant with United States Pharmacopeia (USP) guidelines. “ M E T T L E R T O L D E D O ’s n e w c o n d u c t i v i t y s e n s o r s o f f e r substantial improvements in accuracy, rangeability, and stability compared with analog sensors,” said Christie Martin, Conductivity Product Manager at METTLER TOLEDO Thornton. ”Combined with the benefits of ISM, the UniCond 4-E sensors provide exceptional performance in a wide range of chemical, pharmaceutical, and power industry applications.”
Quaternary Diaphragm Pumps Help Optimise Radial Flow Chromatography Quattroflow, a leading brand of positive displacement quaternary diaphragm pumps, is offering a full line of single-use quaternary diaphragm pumps that make them ideal for incorporation into Radial Flow Chromatography (RFC) systems that are used to adsorb and purify Active Pharmaceutical Ingredients (API) during the “downstream” stage of biopharmaceutical production. Typical chromatography-column design is “axial,” wherein the chromatographic media (usually a resin) are packed in a flat, broad, pancake-like cylinder that is both extremely heavy and space-consuming. RFC, on the other hand, takes the horizontal chromatography cylinder and orients it vertically so that the media is wrapped around it, which reduces both the system’s footprint and weight while maintaining the high level of purification and fractionation of the API that is required. 48 September 2013
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A critical step in optimising the performance of an RFC column is the packing of the chromatography media (resin). Quattroflow pumps—which are available in QF-150, QF-1200, QF-4400, QF-5050 and QF20K sizes—are perfect for this application because their four-piston/four-diaphragm method of design and operation delivers low pulsation, gentle product handling, a large turndown ratio, high flow-rate accuracy, low noise and a compact construction. All Quattroflow pump models also offer the option of single-use configurations with replaceable plastic heads, which eliminates the need for time-consuming cleaning between batches. This increases the product’s speed-to-market capabilities, which is a crucial consideration when attempting to maximise the product’s availability within its patent window.
Telesso Generates Funds to Develop Mimetica’s Topical Acne Treatment Telesso Technologies Limited launched a USD 6.5 million capital raising in connection with its acquisition of Mimetica and its re-listing on the Australian Securities Exchange. The funds will be used to support the Phase 2 clinical trial of Mimetica’s potential breakthrough topical acne treatment MTC896. MTC896 is a small molecule therapeutic designed to reduce excess sebum (oil) production. There is a well documented correlation between excess sebum production and acne. The Company is seeking to demonstrate that MTC896 is effective in reducing sebum production and, therefore, in reducing or preventing the occurrence of acne. There is no currently approved topical acne treatment that reduces the excess sebum production. In clinical trials conducted to date the topical formulation of MTC896 has demonstrated a favourable safety profile with positive initial indications of its ability to reduce sebum production. The planned Phase 2 clinical trial will take place in the US and will seek to demonstrate clinical efficacy in reducing acne in 240 subjects with moderate-to-severe acne in a 12-week double blind, randomised controlled study. The demand for improved acne therapeutics is high with few treatment innovations or improvements in the past ten years. Despite this the acne market in 2010 accounted for approximately USD 2.8 billion in prescription drug sales across the seven major target markets of the US, Japan, Germany, France, Italy, UK and Spain. Telesso will issue scrip to Mimetica shareholders to acquire all shares in Mimetica. Existing Telesso shares will be consolidated at a ratio of approximately 6.7 shares to one. Following completion of the capital raising and the acquisition of Mimetica, Telesso Technologies intends to change its name to Mimetica Limited, subject to shareholder approval. Pharma Bio World
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Carestream Health Ranks 23 rd on 2013 InformationWeek 500 Carestream Health announced it ranked 23 rd on this year ’s InformationWeek 500 – a list of the top technology innovators in the US Carestream was the only supplier of healthcare imaging and information technology included among the top 50 companies on the list. “Carestream’s focus is on creating innovative new technologies that deliver exceptional value to both physicians and patients while offering cost-effective, easy-to-use tools that can enhance the delivery of healthcare worldwide,” said Bruce Leidal, Carestream’s CIO. “Our MyVue Web-based patient portal demonstrates all aspects of this objective. The portal gives patients secure, online access to their own medical imaging data. Patients can then store and share this information—creating the ability for them to collaborate with desired specialists and play a greater role in their own healthcare. This technology is easy and affordable for healthcare organisations to install.” “The theme of this year’s InformationWeek 500 is digital business. It’s a movement, rooted in data analytics, mobile computing, social networking and other customer-focused technologies that are turning companies and industries on their ear,” said InformationWeek Editor In Chief Rob Preston. “Every enterprise is now a digital business — or needs to become one fast. The companies in our ranking are leading the way.”
Av e s t h a g e n A n n o u n c e s L i c e n c e Agreement for AvestaDHA Technology Avesthagen Limited, India’s leading integrated systems biology platform company announces License Agreement with one of the world’s leading specialty chemical companies for its 100 per cent vegetarian AvestaDHA for animal feed application. The agreement is non–exclusive and Avesthagen stands to earn USD 30 Million over the next decade. Dr Villoo Morawala Patell, Founder and Chairperson Avesthagen said, “This is one step towards our continuing commitment to discovery and commercialisation of science based products that promote health and well-being throughout life. AvestaDHA will serve as an acceptable and safe source of DHA for the much neglected field of animal health.” Avesthagen’s innovative patented and trademarked technology allows commercial production of superior quality, 100 per cent vegetarian AvestaDHA derived from microalgae found in the Indian Ocean. Adds Dr Patell, “Avesthagen is open for global licensing, manufacturing and marketing alliances for human and medical nutrition, animal feed and many other applications. AvestaDHA is targeted at improving the nutritional health of the bottom of the Pharma Bio World
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pyramid and Avesthagen invites like-minded government, private organisations and civil society to join in the mission.” Avesthagen developed AvestaDHA with a grant from CSIR under the New Millennium Technology Leadership Initiative (NMITLI) scheme for production of cost effective and renewable sources of DHA & other Long Chain Polyunsaturated Fatty Acids. The project also involved the National Institute of Oceanography, the Indian Institute of Integrative Medicine, Jammu, and the Indian Institute of Chemical Technology, Hyderabad.
Bosch Launches Non-contact Product Distribution System Bosch Packaging Technology, one of the leading suppliers of complete solutions in processing and packaging technology, is introducing the new product distribution system Transver SDP in cooperation with its partner Rotzinger AG at PACK EXPO Las Vegas 2013 and FachPack 2013 in Nuremberg, Germany. Ideal for companies seeking to automate their packaging lines, the Transver SDP is especially suited to meet the demands of the world’s growing food markets. The product distribution system features a modular depositing pullnose station designed for fully automated format changeovers and simple adjustment to product-specific characteristics. In addition, the modular design of the station supports easy maintenance and cleaning. The non-contact belt system operates without side guides ensuring high product quality – even for sticky and fragile food products, such as cereal bars, muffins, soft biscuits, cupcakes, chocolates and irregularly-shaped baked goods. The Transver SDP features the latest servo-drive technology to ensure efficiency and reliability. The system can be easily integrated upstream into existing packaging lines, giving manufacturers the benefit of a single-source solution supplier. “For companies looking to automate their packaging operations, the Transver SDP provides a particularly attractive price performance ratio,” said Andreas Schildknecht, global product manager for horizontal packaging at Bosch Packaging Technology. “Manufacturers profit from the latest product distribution technology to handle even the most challenging food products, achieving a high Overall Equipment Effectiveness (OEE).” To support hygiene, an easy-to-clean stainless steel frame was designed to withstand cleaning solvents and processes. In addition, double wing doors allow full access. Other hygienic elements include the hybrid signal and power cables to minimise wiring and speed up equipment installation. In addition, the Transver SDP features a fast automatic changeover in less than five seconds by simply switching the software recipes. This ensures minimal downtime, maximum product flexibility and repeatability. The new design also supports easy maintenance enabling belt changes in as little as ten minutes. September 2013 49
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New Bill Proposes Setting up of Central Drug Authority The government has introduced a Bill that proposes to set up a Central Drugs Authority (CDA) for regulation of drugs and cosmetics and seeks to bring 17 critical drugs under central licencing. The Drugs and Cosmetics (Amendment) Bill, 2013 covers various aspects of drugs and cosmetics including regulation of clinical trials and the medical equipment sector, having separate chapters on clinical trials and medical devices. The bill that will be replacing the Drugs and Cosmetics Act, 1940, was introduced on 29th August in the Rajya Sabha by Health and Family Welfare Minister Ghulam Nabi Azad, who also withdrew the Drugs and Cosmetics (Amendment) Bill, 2007. The new Bill seeks to establish the Central Drugs Authority (CDA), a 19-member overarching body to regulate the drugs and cosmetics sector that will be headed by the Secretary, Health and Family Welfare. The CDA will specify regulations and norms for effective functioning of central and state drug licencing authorities and will periodically assess their functioning. It can also review, suspend or cancel any permission or licence for drugs and cosmetics manufacturing.
Sun Pharma Announces USFDA Approval for Generic Prevacid Sun Pharmaceutical Industries Ltd announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prevacid, Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg. Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg are therapeutic equivalents of Takeda’s Prevacid Delayed-Released Capsules. These Capsules have annual sales of approximately USD 430 million in the US. Lansoprazole Delayed-Release Capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.
Ajanta Pharma Among ‘Asia’s 200 Best Corporations Under a Billion’ Ajanta Pharma Limited, a specialty focused pharmaceutical formulation company, featured among the ‘Forbes Asia’s 200 Best under a Billion’ list consecutively for the second year. It is indeed an important moment, as the company’s efforts have been recognised by a leading publication of world repute consistently for past two years as one of the best performing companies in Asia under a billion dollars. Only 19 Indian companies from various industries have been able to make to this prestigious compilation, including Ajanta. 50 September 2013
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Forbes Asia’s editors maintain a database of 15,000 stock-traded companies in Asia-Pacific region with revenues between USD 5 million and USD 1 billion. 873 companies were short listed and finally the top 200 companies were finalised. Only 52 companies from the last year’s list have re-qualified this year. Based on three stringent criteria of return on equity, growth in sales and earnings & debt-equity ratio, they selected 200 best performing companies and Ajanta is proud to be one amongst this elite list. Commenting on this recognition, Yogesh Agrawal, Managing Director, said “The recognition is a testimony to Ajanta’s aligned, focused and committed efforts coupled with fundamentally strong strategies to build scalable and sustainable business model.”
Takeda & Arbor Announce a Licensing Agreement for EDARBI & EDARBYCLOR Takeda and Arbor enter into a license, development and commercialisation agreement for EDARBI (azilsartan medoxomil) and EDARBYCLOR (azilsartan medoxomil and chlorthalidone) in the US. Takeda Pharmaceutical Company Limited (Takeda) and Arbor Pharmaceuticals Ireland Ltd, a wholly-owned subsidiary of Arbor Pharmaceuticals, LLC (“Arbor”) announced that Takeda and Arbor have entered into a license, development and commercialisation agreement. It will provide Arbor with exclusive rights to market and sell EDARBI (azilsartan medoxomil) and EDARBYCLOR (azilsartan medoxomil and chlorthalidone) in the U.S. market effective September 12, 2013. Under the terms of the agreement, Arbor will have exclusive rights to promote and sell EDARBI and EDARBYCLOR in the United States. In return, Takeda will receive an upfront payment along with a series of future milestone and royalty payments based upon sales of the EDARBI family of products. “This is an opportunity to capture the value that we’ve created in developing and launching the EDARBI family of products while positioning us to optimise our commercial resources to support our recent and anticipated launches of new products,” said Douglas Cole, President, Takeda Pharmaceuticals USA, Inc. “We are pleased to entrust the EDARBI family in the United States to Arbor who will continue to ensure EDARBI products are available as a treatment option to patients with hypertension. Takeda maintains its global commitment to find new therapies and expand upon the cardiovascular metabolic franchise. The EDARBI family of products remains a priority for a variety of Takeda’s markets globally.” “We are excited about our acquisition of US rights to EDARBI and EDARBYCLOR and look forward to representing these important brands to patients and healthcare providers,” said Ed Schutter, president & CEO of Arbor. “As a specialty pharmaceutical company already focused in the cardiovascular area, we are well-positioned to ensure the EDARBI family of products is available to all appropriate patients who may need them.” Pharma Bio World
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Teva Reports Top-Line Results of Luqa Pharma, Stratpharma Extend Armodafinil Collaboration in China Teva Pharmaceutical Industries Ltd announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL) as adjunct therapy in adults with major depression associated with bipolar I disorder. The study reached statistical significance in several important secondary endpoints, such as responder rate and remission. However, it did not reach its primary endpoint to determine whether armodafinil treatment (150 mg per day) is more effective than placebo as adjunct therapy to mood stabilisers and/ or atypical antipsychotics. This study was the third of three, Phase III studies, all of which demonstrated improvements in patient response. However, based on an evaluation of the totality of results, Teva will not proceed with regulatory filings for armodafinil for the treatment of major depression associated with bipolar I disorder. There is no material impact to the Company. “While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system“, said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. “We will continue to focus on our current NUVIGIL indications and we remain committed to improving wakefulness in adult patients with excessive sleepiness associated with shift work disorder, obstructive sleep apnea or narcolepsy.”
Stratpharma AG and Luqa Pharmaceuticals Co Ltd announce that they have signed an extension to their collaboration. The collaboration will now extend past 2020 and encompasses an expanded range of innovative medical devices in the areas of cosmetic dermatology, plastic surgery, burns, wounds & scar management as well as preferential rights to Stratpharma’s new products under development. In February 2013 Luqa launched Stratpharma’s scar therapy gel, STRATADERM, a novel silicone gel formulation for the treatment of scars. The product has been developed using a new silicone polymer technology, which has already become a reference treatment option across China. Under the extended collaboration agreement, Luqa Pharmaceuticals will register and commercialize Stratpharma’s innovative pipeline in China, rolling out four new products over the next three years. Darren Kerr, Stratpharma’s CEO, said “The Stratpharma-Luqa collaboration has brought highly promising outcomes. The excellent results achieved since the launch of STRATADERM in China early this year make us wish to accelerate an extended collaboration to rapidly bring Stratpharma’s new topical medical devices to the fast growing China market. We are very pleased that Luqa has elected to extend this collaboration and believe that this provides a significant endorsement of the potential of Stratpharma’s pipeline.”
Indegene Announces Enhanced Version US FDA Imposes Import Alert on of TrialPedia 2.0 Ranbaxy Indegene, a leading global pharmaceutical and healthcare Ranbaxy Laboratories Limited, said that during the late hours of September 16, 2013, the Company received communication from the US FDA that the regulator has imposed an import alert on Ranbaxy’s Mohali facility. The US FDA also advised that the Mohali facility will be subject to certain terms of the Consent Decree signed in January 2012.
solutions provider, announced a new release of TrialPedia 2.0, its flagship clinical trial analytics and benchmarking platform. This enhanced version has analytics and benchmarking algorithms spanning over 200,000 trials across 200 indications, making it the most comprehensive and effective clinical trial analysis platform in the marketplace.
Ranbaxy will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest.
Today’s Research and Development (R&D), Clinical, Medical Affairs, Health Outcomes, and Business Development and Licensing divisions face dramatic challenges in designing trial programmes, formulating clinical development strategies, and forecasting the future ‘claim space’ in order to benchmark and maximise the value of their pipeline. Operational challenges as well as, time and cost delays in clinical trials can have a significant impact on revenues and future profitability. TrialPedia 2.0 further enhances the quality, speed, and effectiveness of the clinical development and strategic planning process for global pharmaceutical, device, and biotech organisations. This new release includes improved granular search, advanced sub-disease classification, expanded trial and indication coverage, increased geographical scope, and disease-specific interventions.
The US FDA had conducted inspections at Ranbaxy’s Mohali facility in 2012, resulting in certain observations. The Company believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the US FDA. Ranbaxy is hopeful of an early resolution of these concerns. Ranbaxy remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company. Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First’. Pharma Bio World
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SensoTech Introduces 3-A Certified LiquiSonic Sensor Due to the high hygienic requirements in the food, beverage and pharmaceutical industry LiquiSonic sensors f r o m S e n s o Te c h h a v e a n aseptic design. Some types of sensors are 3-A certified The LiquiSonic sensor of SensoTech by the American 3-A Sanitary has a 3-A certificate and measures Standards, Inc confirming a inline the concentration in hygienic equipment design liquids of the beverage, food or for the food, beverage, and pharmaceutical industry. pharmaceutical industries. With the new LiquiSonic food and pharma sensor SensoTech offers an concentration analyser with 3-A approval. For example, the sensor measures the Plato, Brix or dry matter content. The high measuring accuracy and the in seconds updated and stable data make the process safe and reliable. In combination with a 3” clamp process connection, the sensor is installed directly in the pipe or vessel. The components are made of stainless steel DIN 1.4404 and suitable for CIP cleaning. The robust and fully enclosed design requires no gaskets or “window” to the process. Thus, the LiquiSonic sensor works completely maintenance-free and drift-free. In addition to the concentration measurement, the sensor has a high-precision temperature measurement and a flow/stop monitoring. The sensor electronics are mounted in an enclosed stainless steel housing. The degree of protection is IP68, so that a cleaning of process equipment is possible by high-pressure jet or steam, for example. The sensor with separated electronic housing enables the space-saving integration in cramped installation situations as well as the protection of electronics at strong vibrations within the pipeline.
Global Type 2 Diabetes Drug Market Analysis The global pre-diabetes population is three times the size of the current diabetes patient population. A tremendous increase in the pandemic’s prevalence is in store, and the industry is in dire need of better tools to prevent disease progression. Identifying the precursors to fully developed diabetes through prophylactic therapy is vital, as an unexplored market segment driven by an ever-growing customer base. Meeting patients’ needs through the inclusive therapeutics approach allows practitioners to prevent and manage disease progression. This is crucial in the shift to prevention over treatment in the healthcare market and aligns with the new paradigm of physician quality over quantity. According to Frost & Sullivan’s Competitive Intelligence research, Analysis of the Global Type 2 Diabetes Therapeutics Market, 15 52 September 2013
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new drugs for type 2 diabetes are in late-stage development (Phase 3 and preregistration). The analysis outlines opportunities in the market and the industry’s future through an international evaluation of current drugs and those in the pipeline. “The type 2 diabetes market continually advances, primarily due to the dominance of obesity”, noted the analyst, Frost &Sullivan. “Current studies of this increasingly competitive market are limited in their approach. Seeing this missed opportunity, we began addressing such markets in a new way. Our repositioned Life Sciences programme includes therapeutic product and pipeline analyses and services focused on our clients’ proactive competitive intelligence goals. Among the many trends we see coming, the pharma industry will address the ubiquity of diabetes by a steady stream of new product launches over the next six years.” New diabetes treatment options meet many unmet patient needs. Subsequently, payers and regulatory authorities raise the bar for approval and reimbursement even higher, and the risk of regulatory or commercial failure then increases. Therefore, in a crowded market, new participants must demonstrate a spotless safety profile, along with superior disease control to ensure a competitive position. This is particularly important in the US where the diabetes patient population continues to expand, as is the case in several other countries, such as the United Kingdom, Germany, Spain, China, South Korea and India. The total health expenditures globally allocated to diabetes are eventually more than these regions can afford, as we see inefficient healthcare budgets addressed by expansive measures such as the Affordable Care Act in the US. “Physicians desperately need patient-friendly tools that enable aggressive yet safe management of the disease to prevent complications that are costly to both the patients’ quality of life and the healthcare system”, said the analyst, Frost & Sullivan.
US FDA Approves Strides Arcolab’s Beltapharm Facility Strides Arcolab Limited announced that it has received US FDA approval for Beltapharm’s facility at Milan, Italy. This state-ofthe-art, EU and TGA (Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams. The Company is expecting its first approval of a niche semisolid product by Q1 2014. Commenting on the event, Manish Gupta, CEO, Pharma, Strides Arcolab Limited said, “This approval provides further impetus to our Pharma business and marks our foray into the attractive but complex semi-solid market in US. Our first product, which is expected to be commercialised by Q1 2014, has undergone extensive clinical trials. The product will be marketed by one of the top 10 generic companies in US market.” Strides is developing a portfolio of liquids and semi-solids products for the US and EU markets and currently has over 12 products at various stages of development/approvals. Strides already sells semi-solids in the UK market. Pharma Bio World
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UBM India Pharma Awards – Celebrating Excellence! The Indian pharmaceutical industry currently tops the chart amongst India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organised sector, the Indian pharmaceutical industry is estimated to be worth USD 23 billion; both domestic and export, growing at about 14 to 15 per cent annually. Taking the leadership and expertise of connecting the pharma businesses through CPhI and P-MEC India, which is South Asia’s largest and most comprehensive event for the pharmaceutical industry, to the next level, UBM India is set to honour path breaking excellence, by hosting the press conference on “Awarding Excellence in the Pharmaceutical Industry” to announce the launch of UBM India Pharma Awards on 17 th September 2013 at the Cowasjee Jehangir, ITC Grand Central, Parel, Mumbai. The press conference will be followed by the unveiling of the trophy for the UBM India Pharma Awards. The conference was presided over by Ajit Singh, Chairman, ACG- Worldwide; Mural Nair, Partner- Ernst & Young, and Joji George, Managing Director- UBM India.“
reduced total cost of ownership under GE’s guiding principle of ‘Humanizing MR’. “I am proud to be the first adopter of MR360 Advance 1.5T in Haryana. This exciting new technology will be a real boon to the physicians and patients of Hisar and surrounding regions. The digital broadband 1.5T 60 cm bore MR has a patient appealing design, acoustic noise reduction technology and adjustable patient table which will be a boon to the patients undergoing the radiation free MRI. This system will help us achieve excellent image quality and patient comfort. The system can diagnose brain, spine, Musculoskeletal and Liver diseases, and enable body imaging and early detection of cancer. Most of the 1.5T MRs have conventional analog copper cables to carry images from the magnet room to the equipment room. While doing so there is a loss of data, referred to as Noise. In this new MR system, the data will now be carried using optical fiber cables which will significantly reduce noise and improve image quality. I am privileged to be the early adopter of this world-class MRI system” said Dr G R Gupta, Director, Manglam Imaging Centre, Hisar. Incidentally, the Manglam Imaging Centre was the first in Haryana to provide MRI services to the public in 2002. MRI uses Radio Frequency (RF), audio frequency and static magnetic fields to visualise detailed structures of the human body. Conventional MRI systems use analog components for the signal acquisition and processing needed to produce images of the human body.
The press conference will provide details on how the India Pharma Awards will honour companies who have excelled in Pharmaceuticals and who have contributed to the growth and development of the Indian industry and overall economy. UBM India on 2 nd December, 2013 through this award ceremony will recognise and reward select, pathbreaking initiatives undertaken by the Indian Pharmaceutical industry around key areas of quality, product design, cost management, packaging, corporate social responsibility, research & development. The press conference will also specify the categories for the awards and the jury members for the same.
Roche Nominates Christoph Franz as New Chairman
The event was also graced by the honourable jury of the UBM India Pharma Awards, including Dr Ajit Dangi, President and CEO, Danssen Consulting; Devinder Pal, President, Catalyst Pharma Consult; Murali Nair, Partner Ernst & Young; Kaushik Desai, Director, Drug Information Association (DIA). The Indian Pharmaceutical sector has more than 10,000 registered units.
Christoph Franz New Chairman, Roche
At the forthcoming Annual Shareholders Meeting on 4 March 2014, the Roche Board of Directors will propose Christoph Franz to be elected as Chairman of the Board. Christoph Franz is thus nominated to succeed Franz B Humer, who announced at the last shareholder meeting that he would not be standing for re-election. Christoph Franz will not renew his contract as CEO of the Lufthansa Group, which expires on 31 May 2014.
Haryana’s First Digital Broadband MRI System Unveiled
Commenting on the nomination of Christoph Franz, Roche Chairman Franz B Humer said “With Christoph Franz, Roche is getting a chairman with outstanding personal qualities and an impressive record as head of a major global company. I am sure that his extensive experience, exceptional global network and strong links to Switzerland will be great assets.”
Dr G R Gupta’s Manglam Imaging Centre and GE Healthcare, a leading provider of imaging technologies announced the launch of Haryana’s first 1.5T Digital Broadband MR system –GE Optima MR360 Advance 1.5T. The MR360 Advance Digital broadband MRI provides superior high definition image quality and addresses the demand for, increased patient comfort, increased productivity and
Christoph Franz said “I am delighted that the Board of Directors has nominated me to become the next chairman of the Roche Group. Roche is an outstanding company. As a board member I have had ample opportunity to get to know and admire its strong business performance and corporate culture. Strategically, Roche is in very good shape, and I am looking forward to taking on this opportunity.”
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Ec kert & Zie gle r Aqu ir es BTG ’s Brachytherapy Business BTG plc, the specialist healthcare company, announces the sale of its brachytherapy business to Eckert & Ziegler Group, based in Berlin, Germany. Under the terms of the agreement, all of BTG’s brachytherapy assets, including the products, associated intellectual property and the facility in Oxford, CT, USA, will transfer to Eckert & Ziegler on completion, which is anticipated in around 30 days. BTG will receive USD 5 million on closing together with a 30 per cent share of revenues from the products that are transferring for a period of 12 months commencing either with the start of production by Eckert & Ziegler or on January 2014, whichever is first. Louise Makin, Chief Executive Officer, commented: “We are very pleased to reach this agreement with Eckert & Ziegler. The prostate brachytherapy market has not been core to BTG’s business, but we believe our leading brachytherapy products and dedicated employees will fit very well as part of the Eckert & Ziegler Group.” BTG acquired the brachytherapy business in January 2011 when it acquired Biocompatibles International plc. In the financial year ended 31 March 2013, the brachytherapy business generated 7.3 million pound of the Group’s 233.7 million pound revenues and contributed less than 1.0 million pound of the Group’s underlying operating profit (excluding acquisition adjustments and reorganisation costs) of 69.0 million pound. In May 2013, Biocompatibles voluntarily stopped the manufacture and distribution of the brachytherapy products following receipt of a warning letter from the FDA citing concerns relating to process validations, data analysis, complaint investigations and environmental controls at the facility. Significant progress has been made in identifying and implementing remedial actions to address the issues cited. Eckert & Ziegler will be responsible for completing this work and recommencing manufacture and sale of the products.
Teva’s New Liquid Formulation Gets FDA Nod Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection. TREANDA is indicated for use in patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and in patients with chronic lymphocytic leukemia (CLL). The efficacy of TREANDA in CLL relative to first line therapies other than chlorambucil has not been established. This new liquid formulation removes the step of reconstituting lyophilised powder with sterile water prior to adding the medicine to the dilutent and administering to a patient. 56 September 2013
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“By eliminating the need for reconstitution, a step is removed making dose preparation fast and convenient for healthcare professionals,” said Jim Koeller, MS, Professor, University of Texas at Austin, College of Pharmacy. Teva was assigned a Priority Review designation for the supplemental New Drug Application (sNDA) for the new liquid formulation of TREANDA, which was submitted to the FDA on March 8, 2013. The FDA designates Priority Review for drug applications that would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. “Teva is committed to continuously improving our medicines to deliver greater value to all stakeholders,” said Bill Campbell, Vice President and General Manager, Teva Oncology. “With this new liquid formulation of TREANDA, we are building on the legacy of TREANDA, which has played a valuable role since 2008 in the treatment of patients with CLL or indolent B-cell NHL that has progressed.”
Boston Scientific Commences IAS, Innovation Centre in Shanghai Reinforcing its ongoing commitment to leadership in the global medical technology market, Boston Scientific Corporation officially opened the China branch of the Boston Scientific Institute for Advancing Science (IAS) as well as its new Innovation Centre in the country. Through these state-of-the-art facilities Boston Scientific expects to foster local talent while sustainably developing innovative technologies uniquely suited to the China market. “’Advancing science for life’ is at our core, and the facilities we are dedicating demonstrate our commitment to innovation in professional education and dedication to saving and improving the health of Chinese patients through innovative technologies,” said Michael F` Mahoney, President and Chief Executive Officer, Boston Scientific “China is key to our ongoing global expansion, and we believe that initiatives such as the IAS and Innovation Centre will help us to continue adapting to the unique demands of the China market.” The IAS offers Chinese medical practitioners training in clinical practice and multidisciplinary programmes in Interventional Cardiology, Cardiac Rhythm Management and Electrophysiology, Endoscopy, Peripheral Interventions and Urology and Women’s Health. These programmes are intended to raise medical professionals’ awareness of the latest industry trends as well as their knowledge of innovative technologies. All existing professional education programmes or platforms in the market such as Horizon Academy and the company’s E-Club project will be integrated into the IAS. It is anticipated that the IAS in Shanghai will offer training courses for more than 700 professionals every year. IAS is also expected to cooperate with top medical universities and colleges in China to launch clinical courses for students, contributing to the development of China’s medical industry. Pharma Bio World
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Antares Pharma Initiates Vibex QS T Study Antares Pharma, Inc announced that the first patients have been dosed in a clinical study evaluating testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the VIBEX QuickShot autoinjector device in testosterone deficient adult males. Up to 45 patients will be enrolled at approximately eight investigative sites in the United States. Paul K Wotton, PhD, President and Chief Executive Officer, stated, “We are very excited about the QuickShot Testosterone (QS T) opportunity because we believe it will fill a real need in thegrowing testosterone replacement market for a convenient self-administered injectable product.” Dr Wotton continued, “Our proprietary QuickShot device is designed to discreetly administer a fixed dose of testosterone subcutaneously in a matter of seconds. We believe the self-contained QuickShot technology could potentially eliminate transference issues currently seen in the market leading topical testosterone products. The QS T is another example of continued execution of our combination product strategy where we expect to create added value for physicians, patients and shareholders alike.” The proprietary VIBEX QS device offers a dose capacity of up to 1 ml and the design can be scaled for larger volumes. The device design emphasizes enhanced performance on the attributes most critical to patient success – speed, comfort and discretion. The State-of–the Art engineering accommodates fast injection of highlyviscous drug products such as testosterone that stall lesspowerful conventional auto injectors.
Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. In the knee, this cartilage can be damaged by a traumatic sports accident or a bad fall. A painful injury for patients, repairing articular cartilage is a challenge for doctors to treat since the tissue has no capacity to heal itself. GelrinC is a biodegradable hydrogel implant designed to treat cartilage defects in the knee. It is administered as a liquid to fill any shape of cartilage defect and it is then converted into a solid after 90 seconds of exposure to ultra-violet light. The GelrinC implant naturally degrades within 6-12 months and is replaced with functional and durable cartilage. After two years of study, patients had a substantial improvement of the Knee injury and Osteoarthritis Outcome Score (KOOS), excluding the sports subscale, of 23.6 points at 18 months, representing a 43 per cent improvement, and 32.9 points at 24 months, representing a 60 per cent improvement (52.6 vs. 84.1). KOOS is a patient-reported outcome measurement instrument developed to assess a patient’s opinion about their knee and associated problems. Scores from the International Knee Documentation Committee (IKDC), another measure of patient progress, were even more impressive. The subjective questionnaire showed an improvement of 86 per cent at 18 months and 94 per cent at 24 months (40.4 vs 78.4).
Actavis Unveils Generic Lidoderm
GelrinC Implant Shows Efficacy in Knee Cartilage Damage Treatment Regentis Biomaterials announced new clinical data demonstrating the efficacy and safety of its GelrinC implant for treating articular cartilage in injured knees. As presented at the International Cartilage Repair Society World Congress in Izmir, Turkey, the clinical results demonstrated sustained knee function improvement over 24 months after implantation and significant pain reduction. In addition, the clinical safety data showed that adverse effects were limited and comparable to those reported in similar studies with no serious adverse events related to the implant. “These results show that GelrinC is safe and that the treatment effectively regenerates high quality cartilage,” said Regentis Biomaterials president and CEO Alastair Clemow. “While recovery rates for knees treated with standard procedures plateau and even decrease over time, GelrinC patients showed constant improvement over the course of the study.” Pharma Bio World
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Paul Bisaro, President and CEO, Actavis
Actavis, Inc has launched a generic version of Lidoderm (lidocaine topical patch 5 per cent), as part of an exclusive settlement agreement with Endo Pharmaceuticals Inc and Teikoku Seiyaku Co, Ltd. Actavis has begun shipping the product and believes that, under applicable Hatch Waxman rules, it is entitled to 180 days of marketing exclusivity. Lidoderm is a local anesthetic indicated to relieve post-shingles pain.
“Thanks to this settlement agreement, consumers across the country are today benefitting from generic competition on Lidoderm more than two years before the product’s patents expire,” said Paul Bisaro, President and CEO of Actavis. “We are pleased to be able to provide patients with this more affordable treatment option, while offering yet another reminder of how patent settlements have saved and continue to save consumers billions of dollars and ensure the more-timely introduction of generic competition.” “The launch of generic Lidoderm also marks the culmination of a USD 44 million expansion of our state-of-the-art pharmaceutical research, development and manufacturing facility for transdermal and topical gel products in Salt Lake City, Utah. Initiated in 2011, the expansion involved retrofitting approximately 20,000 sq ft of existing space, constructing approximately 17,000 sq ft of new manufacturing space and adding approximately 300 new jobs,” added Bisaro. September 2013 57
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Eisai’s Subsidiary Signs Collaborative Deal with Selvita SA Eisai Co, Ltd announced that its US research subsidiary H3 Biomedicine Inc has entered into a collaborative agreement with Selvita SA , one of the largest drug discovery companies in Eastern Europe, to create novel anticancer agents. Under the collaboration, both companies will seek to create novel anticancer agents through identification and validation of several kinases as therapeutic targets for cancers with specific genetic characteristics. Recent advances in human cancer genomics have revealed promising drug creation targets that are leading to novel concepts in cancer treatment. H3 Biomedicine seeks to identify genes that are the root causes of cancer and to develop medicines that demonstrate high efficacy in treating specific cancers that possess those genetic features. H3 Biomedicine maintains a set of unique tools and research engines in bioinformatics, which analyses the immense amount of data collected in cancer genomics, and target validation, which seeks to define new drug targets. H3 Biomedicine’s collaborator in this agreement, Selvita, started its first kinase discovery programmes in 2008 and today has built one of the world’s most robust kinase discovery platforms. Together, the joint research conducted under this agreement will complement the technological bases of both companies and accelerate validation of the importance and druggability of kinase targets to create new drugs based on cancer genomics and discovery research against those targets. Through the validation of drug targets based on human cancer genomics information and achievement of Proof of Concept (POC) for the targets in preclinical and clinical research, H3 Biomedicine seeks to deliver on the creation of breakthrough medicines. Eisai shares this ambitious drug discovery vision upheld by H3 Biomedicine and will continue to make contributions by delivering highly efficacious, innovative treatments to patients living with cancer worldwide.
Sanofi Re-launches Rolaids in US Sanofi US and its consumer health business Chattem, Inc have re-introduced Rolaids to stores across the United States. The iconic brand returns after a three-year hiatus in the marketplace and follows Chattem’s acquisition of Rolaids earlier this year. “For the last few years there has been a significant gap in the overthe-counter antacid marketplace here in the US,” said Zan Guerry, Chief Executive Officer, Chattem. “Millions of people who suffer from frequent heartburn and acid indigestion can once again turn to Rolaids to help relieve their symptoms.” Rolaids is sold in retail stores across the United States and is available in both tablets and a new liquid form. The liquid is a first for the brand, as is new Ultra Strength formulation in both tablets and 58 September 2013
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liquid. Ultra Strength Tablets and Liquid deliver Rolaids’ strongest level of acid neutralisation. “Incorporating Rolaids into Chattem’s portfolio further strengthens Sanofi’s position as a leader in the US consumer healthcare sector and helps to further diversify our category offerings,” said Anne Whitaker, President, North America Pharmaceuticals, Sanofi. Heartburn occurs when the opening between the stomach and esophagus malfunctions and allows stomach acid to enter the esophagus. More than two-thirds of all US adults experience heartburn at least once per month. Chattem completed the acquisition of the worldwide rights to the Rolaids brand from McNeil Consumer Healthcare Division of McNEIL-PPC, Inc on January 7, 2013.
Columbia Labs Acquires UK-based Molecular Profiles Columbia Laboratories Inc has acquired Molecular Profiles Ltd, a privately-held, cash-flow positive, UK-based pharmaceutical development services company, for total consideration of approximately USD 25.0 million comprising USD 16.7 million in cash and 1,051,323 shares of Columbia common stock, representing ten to eleven times Frank Condella Molecular Profiles’ projected EBITDA1 President and CEO for its fiscal year ending July 31, 2014. Columbia The newly issued shares are subject to a twelve-month lock-up period. Excluding transaction costs, the acquisition is expected to be immediately accretive. Additionally, Columbia expects to realise a double-digit impact to its EBITDA1 and operational synergies of up to USD 400,000 annually. This acquisition was unanimously approved by the Boards of Directors of both companies and received the approval of Molecular Profiles’ shareholders. No further approvals are anticipated to be required. In addition, Molecular Profiles’ CEO and co-founder, Dr Nikin Patel, will join Columbia’s Board of Directors. “This transaction represents an exciting step in Columbia’s ongoing transformation, and has numerous strategic advantages,” said Frank Condella, Columbia’s President and CEO. “Consistent with our stated strategy, we are deploying our capital to acquire a growing, cash-flow positive, and profitable company with a large customer base that strengthens and significantly diversifies Columbia’s revenue stream. We look forward to its continued growth as Molecular Profiles further penetrates the growing pharmaceutical outsourcing market for formulation development and manufacturing services.” On an unaudited basis, Molecular Profiles’ recorded approximately USD 9 million in revenues for its fiscal year ended July 31, 2013. The company maintained a CAGR of 15 and 14 per cent for revenue and EBITDA, respectively, over the trailing four fiscal years. Pharma Bio World
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biotech news Roche’s New Formulation of Herceptin Approved for Treating Breast Cancer Roche announced that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. The approval is for both early and later stages of treatment. Herceptin is a humanised monoclonal antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. The mode of action of Herceptin activates the body’s immune system and suppresses HER2 signalling to target and destroy the tumour. Since Herceptin was first approved in 1998, this targeted medicine has been used to treat more than 1.3 million patients worldwide. Given on its own as monotherapy, as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve overall survival, response rates and disease-free survival while maintaining quality of life in women with HER2positive breast cancer. Eligibility for Herceptin treatment is determined by a diagnostic test, saving time from the outset by identifying those patients who would derive greater benefit from alternative treatments. The subcutaneous form of Herceptin is a ready-to-use liquid formulation that is administered as a 600 mg/5 ml fixed dose every three weeks. This simplifies healthcare procedures by removing the need for reconstitution or dose calculation according to the body weight of individual. A loading dose is not required when using subcutaneous administration. The subcutaneous formulation uses technology developed by Halozyme Therapeutics, Inc that temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the 5 ml volume of the subcutaneous formulation of Herceptin to be rapidly dispersed and absorbed over a greater area. Research shows that maintaining a normal life and spending time with friends and family can improve the wellbeing of women with breast cancer. The new formulation may reduce the amount of time patients spend in hospital receiving treatment with Herceptin as it can be administered at least six times faster than the standard intravenous form.
Lupin Receives FDA Approval for Generic Rifadin Capsules Pharma Major Lupin Limited announced that its US subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received final approval for its Rifampin Capsules USP, 150 mg and 300 mg strengths from the United States Food and Drugs Administration (FDA). Lupin’s Pharma Bio World
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Rifampin Capsules USP, 150mg and 300mg are the AB - rated generic equivalent of Sanofi Aventis’ Rifadin Capsules 150 mg and 300 mg strengths. Rifampin Capsules is indicated for the treatment of all forms of Tuberculosis and for the treatment of asymptomatic carriers of Neisseria meningitides to eliminate meningococci from the nasopharynx. Rifadin Capsules had annual US sales of approximately USD 18.5 million (IMS MAT Mar 2013). Lupin is one of the pioneers in the fight against Tuberculosis and holds global leadership positions in the Anti-TB segment.
Biocon Partners with CytoSorbents to Market CytoSorb Biocon Ltd, Asia’s largest biotech company, and CytoSorbents Corporation, based in the United States, announced that they have entered into a strategic partnership with an initial distribution agreement for India and select emerging markets, under which Biocon will have the exclusive commercialisation rights for CytoSorb, a novel therapy for the management of sepsis. CytoSorb is a safe and effective extracorporeal cytokine filter, designed to target the prevention or treatment of organ failure which is the cause of nearly half of all deaths in the intensive care unit. If left unchecked, ‘cytokine storm’ caused by excessive cytokine production can cause massive inflammation, organ failure and death in common life-threatening conditions such as sepsis, burn injury, trauma, lung injury, and pancreatitis. CytoSorb has CE Mark regulatory approval, and is clinically proven to control cytokine storm in critically-ill patients by reducing key cytokines in blood by 30-50 per cent. It also works easily with standard dialysis machines used in hospitals. Biocon and CytoSorbents will initially focus on the treatment of sepsis - the end result of an excessive immune response to infection. The effective treatment of sepsis needs to address two components – the infection and the over-activation of the immune system. By combining Biocon’s critical care antibiotics to treat the infection that are also compatible with CytoSorb therapy to modulate the immune response, the two companies will be providing the most comprehensive solution for sepsis management in the market. Kiran Mazumdar Shaw, Chairperson & Managing Director, Biocon Ltd, said, “We believe our partnership with CytoSorbents will enable us to address the huge unmet need of sepsis management in India and emerging markets. CytoSorb is a ‘first-in-class’ therapy that can provide an effective solution to physicians to treat critically ill patients suffering from sepsis. This move reflects our commitment to bring differentiated products to India that will help address various healthcare challenges faced by millions of patients in our country. ” September 2013 59
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GSK Receives Marketing Authorisation Celltrion Completes Filing Procedure for Tafinlar for Approval of Remsima in Japan GlaxoSmithKline announced that the European Commission has granted marketing authorisation for Tafinlar (dabrafenib) as an oral targeted treatment indicated in monotherapy for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) in adult patients with a BRAF V600 mutation.1 Dabrafenib is not indicated for the treatment of patients with wildtype BRAF melanoma. Before taking dabrafenib, patients must have confirmation of a BRAF V600 mutation using a validated test.
Celltrion announced that the company has completed filing procedure of Remsima to obtain Japan’s Ministry of Health, Labour and Welfare (MHLW) approval.
“Authorisation of Tafinlar represents an important step in GSK’s ongoing effort to bring new treatment options to cancer patients, especially as we have brought it to market in less than five years after our initial testing,” said Paolo Paoletti, MD, President, GlaxoSmithKline Oncology. “With this new personalised medicine, we hope to make a meaningful difference in the lives of appropriate patients with metastatic melanoma; a devastating disease and a cancer with one of the lowest survival rates.”
Remicade, the originator product of Remsima, is the most successful TNF antagonist treatment antibody in terms of market share in Japan and its sales have peaked at 90 billion Yen last year. Japan is the second largest market for Remicade following the USA.
Dabrafenib is a kinase inhibitor that targets BRAF, a key component of a biological pathway in the body that regulates the normal growth and death of cells, including skin cells. The availability of a diagnostic test allows the identification of patients with unresectable or metastatic melanoma who have the BRAF V600 mutation, and therefore are eligible to receive this therapy.
High-Throughput Pipette Eliminates Complex Programming Time Current modern biotechnology applications are making use of molecular biology methods and exponentially increasing the number of high-throughput experiments being conducted in labs worldwide. METTLER TOLEDO subsidiary Rainin Instrument has addressed the needs of operators running these high-volume experiments with Liquidator 96. This bench-scale, 96-channel manual pipetting solution provides accuracy without forcing operators to contend with electronic systems or complex computer programming. The result is pipetting ease along with significant efficiency gains. Liquidator 96 allows pipetting in 96- and 384-well plates, PCR plates, 8- and 12-channel reservoirs as well as 96-deepwell plates. This enhanced handling speed represents a critical pipetting benefit, particularly when working with time-critical ELISA test procedures. Also, because Liquidator 96 works just like a manual pipette, it can be used by lab technicians at any experience level and still deliver reproducible results. Finally, as a personal pipetting system, Liquidator 96 fits any bench-top or laminar-flow cabinet making it suitable for cleanroom conditions. 60 September 2013
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Celltrion jointly conducted clinical trial in Japan with its partner company, Nippon Kayaku. Last July, Celltrion officially completed these clinical trials in Japan. Celltrion expects to launch Remsima in the Japanese market within 2014 as approval procedure usually takes around a year in Japan.
An official from Nippon Kayaku elaborated, “The Japanese approval for Remsima will be good news not only for patients in Japan who previously had limited access to advanced therapeutics, but also for their families and their healthcare providers. As Remsima has already successfully received approval from the EMA, the approval process in Japan is expected to proceed smoothly.”
Nuclea Biotechnologies Acquires WILEX WILEX AG and Nuclea Biotechnologies, Inc, (Nuclea) signed a share deal agreement under which Nuclea acquires all shares of WILEX Inc (Oncogene Science), a wholly owned US subsidiary of WILEX AG. Under the terms of the deal, Nuclea will assume all the assets of WILEX Inc and will also assume responsibility for repayment of USD 2.5 million under an intercompany loan between WILEX Inc and WILEX AG. In addition, WILEX AG is eligible for single-digit royalties on net sales on the HER-2/neu and AIX assays. Concurrently and as essential part of the overall deal, WILEX AG and Nuclea entered into a development agreement under which Nuclea will develop an automated CAIX IVD IHC assay (CAIX Dx) to be submitted for FDA allowance under the Investigational Device Exemption (IDE). This CAIX Dx is intended to be used for patient stratification in a planned pivotal study with RENCAREX and as a potential future companion diagnostic in the adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear the costs for the development of this CAIX Dx as a contribution in kind which will lead to savings of at least USD 2.5 million for WILEXAG. WILEX Inc (Oncogene Science) specialises in serum based oncoprotein diagnostics and provides the only FDA cleared and CE marked IVD ELISA test for the measurement of serum HER-2/neu in the management and monitoring of patients with metastatic breast cancer. Pharma Bio World
01-10-2013 19:45:53
NIH Begins Testing H7N9 Avian Medivir AB Discontinues Agreement Influenza Vaccine Candidate to Develop Hepatitis B Compound Researchers at nine sites nationwide have begun testing in humans an investigational H7N9 avian influenza vaccine. The two concurrent Phase II clinical trials, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are designed to gather critical information about the safety of the candidate vaccine and the immune system responses it induces when administered at different dosages and with or without adjuvants, substances designed to boost the body’s immune response to vaccination. Human cases of H7N9 influenza first emerged in China in February 2013, with the majority of reported infections occurring in the spring. As of Aug. 12, 135 confirmed human cases, including 44 deaths, have been reported by the World Health Organisation. Most of these cases involved people who came into contact with infected poultry. Although no H7N9 influenza cases have been reported outside of China and the virus has not demonstrated sustained person-to-person transmission, there is concern that it could mutate to pose a much greater public health threat. “H7N9 avian influenza virus — like all novel influenza virus strains to which people have not been exposed — has the potential to cause widespread sickness and mortality,” said NIAID Director Anthony S Fauci, MD. “We are now testing a vaccine candidate with and without adjuvant in an effort to prepare for and, hopefully, protect against this possibility.” The two clinical trials, which will enroll healthy adults ages 19 to 64, will evaluate an investigational H7N9 vaccine developed by Sanofi Pasteur. The candidate vaccine was made from inactivated H7N9 virus isolated in Shanghai, China in 2013. Adjuvants are being tested with the investigational vaccine because previous vaccine research involving other H7 influenza viruses has suggested that two doses of vaccine without adjuvant may not produce an immune response adequate to provide effective protection. In pandemic situations, adjuvants also can be used as part of a dose-sparing strategy, which would allow production of more doses of vaccine from the available supply of the viral antigen, thereby allowing a greater number of people to be vaccinated more quickly. In both studies, which are expected to conclude in December 2014, a panel of independent experts will closely monitor safety data at regular intervals throughout the trial. The vaccine studies are being conducted at the eight NIAIDfunded Vaccine and Treatment Evaluation Units: Baylor College of Medicine, Houston; Children’s Hospital Medical Centre, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; Saint Louis University, St Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. The University of Texas Medical Branch at Galveston will conduct the trial as a subcontractor to Baylor College of Medicine. Pharma Bio World
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Medivir AB announced that it has discontinued the development of its hepatitis B compound MIV-210 based on a joint decision with Daewoong Pharmaceutical Co Ltd, (South Korea). Under the terms of this collaboration agreement Daewoong has been responsible for the R&D work. MIV-210 has a demonstrably competitive antiviral activity but, like other drugs of this class, does not completely eradicate HBV. The commercial environment for HBV drugs, with the current standard of care approaching generic status, requires a robust cure profile. To achieve this cure profile would require combination with other drugs with different and new mechanisms. “In light of the characteristics MIV-210 could offer for the treatment of Hepatitis B, we have together with our partner Daewoong decided to abandon the development activities with MIV-210”, said Maris Hartmanis, CEO, Medivir AB.
European Commission Approves Genzyme’s Multiple Sclerosis Treatment Genzyme, a Sanofi company announced that the European Commission has granted marketing authorisation for Lemtrada. Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features. The first treatment course of Lemtrada 12 mg is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. The Lemtrada clinical development programme included two pivotal randomised Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs interferon beta-1a. The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Serious autoimmune conditions can occur in patients receiving Lemtrada. A comprehensive risk management programme will support early detection and management of these autoimmune events. September 2013 61
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Dendreon Announces Marketing Authorisation for PROVENGE in EU Dendreon Corporation announced that the European Commission (EC) has granted marketing authorisation for PROVENGE (autologous peripheral blood mononuclearcells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorisation in the EU. The marketing authorisation provides approval for the commercialisation of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein. John H Johnson, chairman, president and chief executive officer of Dendreon said, “The marketing authorisation of PROVENGE in the EU represents an important achievement for Dendreon. As the first personalised immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE may help extend the lives of appropriate prostate cancer patients.” “With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patient’s own immune system to fight their cancer,” said Prof Karim Fizazi, MD, PhD, Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France. The European marketing authorisation for PROVENGE was granted based upon data from three randomised, placebocontrolled, multi-center Phase III studies, which enrolled 737 patients. In the pivotal Phase III IMPACT study, an improvement in overall survival (OS) was observed, with a median survival of 4.1 months longer in patients who received PROVENGE versus those who received placebo (HR=0.775, 95 per cent-CI 0.614, 0.979, P =0.032). Similar effects were observed in the two supportive studies. “This milestone demonstrates the importance of providing a new therapeutic option with a differing mechanism of action than other approved treatments for appropriate prostate cancer patients in the EU,” said Mark Frohlich, executive vice president of research and development and chief medical officer of Dendreon. “We continue to enroll patients in the EU open-label study, and plan to have a presence at the upcoming European Cancer Organisation (ECCO) and European Society for Medical Oncology (ESMO) conferences.”
Hospira’s Inflectra Approved in Europe Hospira, the world’s leading provider of injectable drugs and infusion technologies, announced the European Commission (EC) approval of Inflectra (infliximab), Europe’s first biosimilar 62 September 2013
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monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis. Inflectra is a biosimilar medicine to the reference medicinal product, Remicade (infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.1 Remicade recorded European sales of over USD 2 billion in 2012. The use of biologic medicines has led to vast improvements in the treatment of conditions such as RA and IBD (inflammatory bowel disease), but these drugs are also responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to EUR 20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK. Inflectra was approved by the EC following review of safety, efficacy and tolerability data from a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In the study, 73.4 per cent of patients receiving Inflectra achieved a greater than or equal to 20 per cent improvement in RA symptoms after 30 weeks of treatment (measured using the ACR20 scoring system), compared with 69.7 per cent treated with Remicade.5 Safety and tolerability data also demonstrated Inflectra’s equivalence to Remicade. The most common side effects are viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.
Aastrom Biosciences to Begin Phase 2b ixCELL-DCM Trial in Canada Aastrom Biosciences, Inc, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, announced that Health Canada has approved the company’s Clinical Trial Application (CTA) to initiate the ongoing Phase 2b ixCELL-DCM clinical trial in Canada. The ixCELL-DCM study, which is currently enrolling patients in the United States, is a randomised, double-blind, placebo-controlled study of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). “As we continue to make progress with our ixCELL-DCM clinical trial in the US, we are very pleased that Health Canada has also now approved our clinical trial application for ixmyelocel-T,” stated David Recker, MD, acting chief medical officer of Aastrom. “With the addition of new trial sites in Canada, we feel confident that we will be able to maintain the momentum in this important clinical research programme while also helping to expand awareness of the benefits of ixmyelocel-T as a potential treatment for patients with advanced heart failure due to ischemic DCM.” Pharma Bio World
01-10-2013 19:45:53
DM Plants
Packaging Machinery (Jumbo Pack)
As the machine name signifies, Model S/M/W/FA/40 is designed with the latest technology and has four chutes attached to the machine. The speed of the machine depends on multiple numbers of drops and rows that has to be packed. This machine is high speed family pack machine. The machine consists of a stepper/servo motor attachment along with pneumatic system for the feeding of biscuits synchronised with the basic machine through PLC control to achieve accuracy of feeding. This reduces the wastage produced and increases the output. Stepper motor or servo motor is used to drive the feeding u n i t . T h e s e le ct io n o f m o t o r so le ly d e p e nds upon the customers requirements.
Hydropure DM plants are used in combination with UV and UF for generation of high purity water for pharma, biotechnology, semi-conductor, cosmetic. and food and beverages industry. The typical pretreatment is filtration and DM plants consist of a two bed system followed by a CATPOL or MB polisher. The plants are built using FRP housing and UPVC valves and piping system. The DM plants are designed for achieving highest treated water quality with lowest consumption of chemicals for regeneration. The DM plant based systems are custom built for any capacity and come with option of fully automatic or manual plant operation. Resins for this are carefully selected to meet the application requirements. The post DM UF system are built using hollow fine fiber membrane of less than 10 KDMWCO for microbial and TOC rejection to achieve the treated water quality complying USFDA, MHRA, WHO, EU and other international pharmacopeias and standards. The UF system is hot water sanitisable up to 85 0C. For more information, please contact:
For more information, please contact: SVM Wrappings Pvt Ltd 26 Blue Rose Indl Estate, Western Express Highway Nr Jaya Petrol Pump, Magethene, Borivli (E), Mumbai 400 066 Tel: 022-28545243m 28546281; Fax: 91-022-28541169 E-mail: info@svmwrappings.com / marketing@svmwrappings.com
Hydropure Systems 412 Diamond Estate, Off Western Express Highway Dahisar (E), Mumbai 400 068 Tel: 022-28978725, 28979097 E-mail: info@hydropure.in
Agitated Nutsche Filter Dryer This is a combination of filter and dryer unit in single equipment to achieve economy in process, space and energy thereby improving profitability. This equipment can be used in manufacturing process of various pharma, intermediate compounds, fine chemicals, chemicals, agro chemicals, pesticides, insecticides, dyes and food products. The Agitated Nutsche filter is a Nutsche type filter designed to separate solids from liquids, it is totally enclosed and is normally operated under pressure or under vacuum. Additionally, the equipment is fitted with a stirrer mechanism. which efficiently agitates the slurry during cake washing, and squeezes the cake during filtration and assists in the automatic discharge of the cake. The ANF comprises of a pressure vessel in which a main shaft rotates and also moves in the vertical direction. Specially designed stirrer blades are mounted on the shaft, capable of performing various function, A side discharge arrangement is provided, closing and opening through hydraulic/mechanical means. A filter plate is located at the base of the vessel in level with the discharge port. The filter medium, usually a filter cloth, is fitted on the filter plate which is replaceable type. For more information, please contact: Bifriends Engg Works W-73 MIDC, Phase 2, Manpada Road, Dombivli (E), Thane, Maharashtra 421 204 Tel: 0251-2871511; Telefax: 91-0251-2871683 E-mail: befriends@bew.net.in
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Process Pump
Hot Melt Extrusion System
Laxmi Hydraulics Pvt Ltd, Solapur, Maharashtra, process pumps are designed to handle liquids in light chemical, petrochemical and pharmaceutial industries. These pumps have low NPSH and high efficiencies and are suitable for horizontal mounting with top central discharge. The rotar with shaft and impeller are dynamically balanced to give low noise level and longer bearing life. Double shielded bearings with high temperature grease are used. No greasing is required as bearings are pre-greased for life.
For more information, please contact: Laxmi Hydraulics Pvt Ltd B-11 MIDC, Chincholi, Solapur, Maharashtra 413 255 Tel: 0217-2357003, 2357004, 2357005 Fax: 91-0217-2357006 E-mail: lhpindia@lhpmotor.com
OMICRON 12 PHARMA is a corotating twin-screw laboratory extruder, specifically designed and developed to the pharmaceutical industry. The ability of this hot melt extrusion system is to generate outstanding dispersive and distributive mixing. It can produce material at an extremely low output rate, which helps in lowering the cost of development of new products. OMICRON 12 PHARMA offers the widest flexibility available in today’s market for R&D projects with the ability to be customized for any given application. Formulation trials are conducted at STEERs Application Development Center situated in Bengaluru.
For more information, please contact: STEER Engg Pvt Ltd #290, 4 th Main, 4 th Phase, Peenya Indl Area Bengaluru, Karnataka 560 058 Tel: 080-23723309, Fax: 91-080-23723307 E-mail: info@steerworld.com
Tray Dryers Tray dryer is conventional drying equipment effective for drying wet powders, sticky/ non-sticky powder suitable for further processing into API processing powder. Other uses include tablet drying and curing. These tray dryers are of high quality and efficiency, in compliance with cGMP norms, built in SS-316/ 316L Grade contact parts. The non-contact parts/external surfaces of the dryers are manufactured from SS-304 Grade l. This tray dryer find application for drying powders, granular crystalline, coarse or similar material in pharma, fine chemicals, dyes, food and allied products. The dryers are available in a range of sizes from 12 to 192 trays per batch capacity and can be customised to suit production requirements to accommodate multiple trolleys till 12 trolleys to match individual requirements. Each trolley can accommodate 48 trays. For more information, please contact: Shiv Shakti Process Equipment P Ltd Shiv Shakti, 407, Shivam Chambers, Next to Sahara, S V Road, Goregoan (W), Mumbai 400 062 Tel: 022-26788480, 26798554; Fax: 91-022026798284 E-mail: office@shivshaktiequipments.com
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Indirect Air Heaters
Axial Flow Fans
Aero Therm offer fully automatic oil/gas fired indirect air heater in capacity ranging from 30,000 to 600,000-kcal/hr.
in special construction.
Maximum operating temperature will be 180 0C for standard models and can be offered higher temperature up to 400 0C
Air heater will be equipped with high efficiency fully automatic oil/gas/burner. Direct fired hot air generator up to 600 0C is also available.
High efficiency axial flow fans have a defined hub ratio type 71 to 25 for a given capacity, pressure and speed. Fans are available in 22 sizes from 225 to 2,500 mm in each type. Drive available for direct mounting/V-belt. Impeller blades are adjustable type and rest at an angle to suit the system resistance. Fans run in parallel to suit capacity and in series for higher pressure. Impeller is made of aerofoil profile from cast aluminium alloys. Bifurcated type fans are available for handling corrosive gases and hot gases. Fans are available in capacity up to 300,000 m 2/hr and pressure up to 100 mm Wg.
For more information, please contact:
For more information, please contact:
Aero Therm Systems Pvt Ltd Plot No: 1517, Phase III, GIDC, Vatva, Ahmedabad Gujarat 382 445 Tel: 079-25890158; Fax: 91-079-25834987 E-mail: contact@aerothermsystems.com
Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling, Rakhial Ahmedabad, Gujarat 380 023 Tel: 079-22910771; Fax: 91-079-22910770 E-mail: info@vacunair.com
Laboratory Devices for Process Technology Bosch Packaging Technology presents a selection of laboratory devices for solid dosage forms from the product brands Huttlin and Manesty. Huttlin GmbH presents its high shear mixer granulator Huttlin Mycromix, Manesty offers customised and highly flexible tablet presses and coaters. Together, Huttlin and Manesty display the laboratory device Solidlab 2. The compact and modular machine combines several process steps in a small space: drying, granulating and coating in the fluid bed, as well as tablet coating in the coater. The modules can be used individually and contain the entire periphery such as inlet and exhaust air handling sensor technology and control system. Huttlin Mycronix is the smallest high shear mixer granulator in the laboratory equipment range. It handles batches from 0.05 to 4 kg. The bottom drive unit Huttlin Gentlewing ensures highly homogenous mixing qualities for granulates. All processing can be easily transferred to production equipment via scale-up. With the Manesty Xpress range of tablet presses, Bosch Packaging Technology fulfills the pharma industry’s needs for flexibility and safety, as well as low investment and operation costs. The Manesty Xpress product range consists of both single and double sided rotary tablet presses as well as a WiP option allowing for flexible tablet production of small, medium and large bath sizes. The machines feature an ergonomic design, short product changeover times, high product yield and Overall Equipment Effectiveness (OEE). For more information, please contact: Robert Bosch GmbH Postfach 10 60 60, D-70049 Stuttgart, Germany Tel: +49 711 811-58502; Fax: +49 711 811-58509 E-mail: christen.poenisch@bosch.com
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SS Seamless & Welded Pipes, Tubes, U-Tubes & Large Dia Welded Pipes Suraj Ltd an ISO-9001, 14001, BS OHSAS 18001 certified company offers SS seamless and welded pipes, tubes and U-tubes, and large dia welded pipes in various sizes, grades and specifications as per customers’ requirements. Suraj has strong presence in global market. They find applications in refinery, petrochemical, food, pharma, fertiliser, oil and gas, breweries, sugar, shipbuilding, etc. Suraj also holds certificates for quality in accordance with AD2000 MERKBLATT W0 and Pressure Equipment Directives [PED] 97/23/EC from TUV Nord and offer material under all national and international third party inspection. Suraj also have their own lab to examine various tests such as hydro test, eddy current, PMI, IGC, UT, RT, spectroanalysis, mechanical properties and others as per the customers’ requirements.
Hot Water Unit The hot water generation system consists of hot water storage tank, hot water pump, shell and tube heat exchanger along with associated piping, electrical and instrumentation. The initial make up feed water shall be supplied at ambient temperature and the water temperature shall be raised to 75 0C and circulated in closed loop to the air-handling units. The return water from these airhandling units shall be at 65 0C Typical system components will be hot water storage tank with dish end; U-tube heat exchanger; circulation/transfer pump; and all interconnecting valves, piping, electrical and instrumentation It finds application in bulk drug and pharmaceutical industries.
For more information, please contact:
For more information, please contact:
Suraj Ltd Suraj House, Opp: Usmanpura Garden Ashram Road, Ahmedabad, Gujarat 380 014 Tel: 079-27540720; Fax: 91-079-27540722 E-mail: suraj@surajgroup.com
Shree Ganesh Process Equipments Pvt Ltd Plot No: F-82/83, MIDC, B/h ASB Co Addl Ambarnath, Dist: Thane, Maharashtra 421 506 Tel: 0251-2620078, 2620742, 2621932; Fax: 91-0251-2620079 E-mail: nhattarde@yahoo.co.in / sgec1304@yahoo.com
Industrial pH Monitors Cole-Parmer offers Thermo Scientific Eutech pH monitor for high reliability in measurement of pH and easy installation and operation via the intuitive pushbutton user interface. Thermo Scientific Eutech pH 550 monitors are used to measure pH, ORP and temperature values in applications including water treatment monitoring, chemical processing and food processing. This pH monitor is 1/4-DIN size and can be either panel or wall mounted. Suitable for indoor or outdoor use, it has weatherproof, IP65-rated housing suitable for harsh environments and is powered via a 9 V DC source. A 110/220 V AC to 9 V DC adapter is included with the pH monitor. The pH monitor has userfriendly menu-driven programmes and calibrations that are easily performed via the push button keypad Single or two point calibrations can be performed with USA or NIST buffer sets. The easy-to-read dual-line display enables instantaneous view of measured readings and set-up configurations for effortless installation and operation Measurements are compensated for temperature variations automatically when used with pH electrodes that have temperature elements. All setup and calibration parameters in this pH monitor is retained in the non-volatile memory to prevent data loss during power outages. Cole-Parmer offers a complete range of instruments, accessories and consumables in electrochemistry measurement and monitoring for lab and process industry. For more information, please contact: Cole-Parmer India Pvt Ltd 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai, Mumbai 400 076 Tel: 022-67162209, 67162222; Fax: 91-022-67162211 E-mail: response@coleparmer.in
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Analytical Instrument Coriolis Pharma, Germany has become the first pharma contract research organisation to use Archimedes, a new analytical instrument supplied by Malvern Instruments. Coriolis Pharma specialises in formulation development for biopharmas such as proteins, peptides and vaccines offers wide variety of services to support product development. Archimedes uses the technique of Resonant Mass Measurement (RMM) to detect and accurately count particles from 50 nm to 5 μm in dia and to measure their buoyant mass, dry mass and size. It has applications in the quantitative characterisation of protein aggregates in the size range currently of new regulatory interest, from 0.2 to 2 μm dia, where aggregates are considered to have a high likelihood of eliciting an unwanted immune response. Uniquely for this size range, Archimedes distinguishes between proteinaceous material and contaminants such as silicone oil.
Eccentric Helical Rotor Pumps UTPSL offers range of eccentric helical rotor pumps in special construction manufactured as per BORNEMANN Germany design acquired by virtue of previous JV partnership. These pumps have stators and rotors manufactured in special design with longer pitch and low eccentricity. Such design offers a unique advantage of operation with low rubbing speed. Also, this means lower axial forces on bearings and joints. UTPSL single screw pumps are available in range of sizes and combination of MoC. These pumps come with special design sturdy cardon joints, which are sealed against liquid. Pumps are available in different sizes with capacity range up to 200 m 3/hr and pressures 6, 12 and 24 bars and special execution pumps up to 80 bars. UTPSLsingle screw pumps find application in different industries like pharma, laboratories, ETP, chemical and petrochemicals and many others.
For more information, please contact:
For more information, please contact:
Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park B Wing – 906 Sector 30A, Vashi, Navi Mumbai 400 705 Tel: 022-39183596; Fax: 91-022-39183562 E-mail: Stuart.Wakefield@malvern.com
UT Pumps & Systems Pvt Ltd 14/7 Mathura Road, Faridabad, Haryana 121 003 Tel: 0129-4045831, 2274861, 2258588, 3299731 Fax: 91-0129-2258584, 2275877. E-mail: sales@utpsl.in
LiquiSonic Sensor Due to the high hygienic requirements in the food, beverage and pharma industry LiquiSonic sensors from SensoTech have an aseptic design. Some types of sensors are 3-A certified by the American 3-A Sanitary Standards, Inc confirming a hygienic equipment design for the food, beverage, and pharma industries. SensoTech offers a concentration analyser with 3-A approval, eg, the sensor measures the Plato, Brix or dry matter content. The high measuring accuracy and the in seconds updated and stable data make the process safe and reliable. In combination with a 3” clamp process connection, the sensor is installed directly in the pipe or vessel. The components are made of stainless steel DIN 1.4404 and suitable for CIP cleaning. The robust and fully enclosed design requires no gaskets or window to the process. Thus, the LiquiSonic sensor works completely maintenance-free and drift-free. In addition to the concentration measurement, the sensor has a high-precision temperature measurement and a flow/stop monitoring. The sensor electronics are mounted in an enclosed SS housing. The degree of protection is IP68, so that cleaning of process equipment is possible by high-pressure jet or steam. The sensor with separated electronic housing enables the space-saving integration in cramped installation situations as well as the protection of electronics at strong vibrations within the pipeline. For more information, please contact: SensoTech GmbH Steinfeldstr. 1, D-39179 Magdeburg–Barleben, Germany Tel: +49 39203 514100; Fax: +49 39203 514109 E-mail: info@sensotech.com
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events diary 5th Pharmacovigilance Congregation 2013 Dates: 20 th November 2013 Venue: Kohinoor Continental Hotel, Mumbai, India 5 th Pharmacovigilance 2013 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constrains, effectively tackling key challenges, overcoming trial agreement and site contract negotiation hurdles. Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development. The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Contact: Deepak Raj Virtue Insight, Plot No – 07, 2 nd Floor Ekambaram Industrial Estate, Alapakkam, Porur Chennai – 600 116 Tel: + (91) - (44) 65515693 | Mob: + (91) 9171350244 E-mail: deepak@virtueinsight.com
BioPharma India Convention 2013 Dates: 25 – 26 November, 2013 Venue: Hyatt Regency, Sahar Airport Road, Mumbai BioPharma India is the region’s leading biopharmaceutical event. This year more than 300 manufacturing, clinical trials and supply chain stakeholders from India and beyond will come together to identify innovation and partnership opportunities as well as best business and operationally effective practices. This year the conference will be made up of three seperate conference tracks as well as a global exhibition. You only need to purchase 1 pass and you can attend the whole event. Contact: Terrapinn Pte Ltd 1 Harbourfront Place, #18-01 Harbourfront Tower 1 Singapore – 098633 Tel: +(65) 6222 8550 | Fax: +(65) 6226 3264 E-mail: enquiry.sg@terrapinn.com 68 September 2013
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Dates: 9 – 11 October 2013 Venue: Chennai Trade Centre, Guindy, Chennai CHEMTECH announces CHEMTECH World Expo 2013 - SOUTH of its flagship event from 9th to 11th October 2013 in Chennai Trade Centre, Guindy, India. Pharma Bio World Expo & conferences will concurrently be organised during the Expo. The international exhibition will have display of state-of-the-art technologies, equipment, accessories and services from national and international players in each sector. Concurrent International conferences EPC World Expo, ChemPetro World Expo, Industry Automation and Process Control World Expo and WaterEX World Expo will have deliberations on topical issues by industry leaders, experts and influencers and offer high level networking opportunities to take the businesses to newer heights. Contact: Chemtech Secretariat 26, Maker Chambers VI Nariman Point, Mumbai 400 021 Tel: + (91)-(22)-40373737 | Fax: +(91)-(22)-22870502 E-mail: sales@jasubhai.com; conferences@jasubhai.com
India Diagnostic Expo Dates:21 – 23 November 2013 Venue: HITEX Exhibition Centre, NAC campus, Madhapur Hyderabad India Diagnostic Expo is going to be held for a period of three days in Hyderabad, India. This expo will attract diagnostic labs, clinical lab professionals, chemists and biochemists from all over the world to discuss about the modern market trends and future market prospective associated with the diagnostic industry. By taking an active part in this expo technical and professional experts related to diagnostic industry will get a scope to share their expertise with the attendees. Contact: SD (India) Corporation 14, Mall Road, 1 st Floor, Hudson Lane, GTB Nagar, New Delhi Tel: +(91)-(11)-47034600/43003757 | Fax: +(91)-(11)-47056500 Pharma Bio World
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bookshelf Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients Author: Ben Goldacre Price: USD 28.00 No of pages: 448 pages (Hardcover) About the book: We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about a drug, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients.
The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (3 rd edition) Author: Martin A Voet Price: USD 28.95 No of pages: 198 pages (Paperback) About the book: The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs.There is simply no other book of its kind available on this important subject.
Drugs for Life: How Pharmaceutical Companies Define Our Health Author: Joseph Dumit Price: USD 17.72 No of pages: 280 pages (Paperback) About the book: In Drugs for Life, Joseph Dumit considers how our burgeoning consumption of medicine and cost of healthcare not only came to be, but also came to be taken for granted. For several years, Dumit attended pharmaceutical industry conferences; spoke with marketers, researchers, doctors, and patients; and surveyed the industry’s literature regarding strategies to expand markets for prescription drugs. He concluded that underlying the continual growth in medications, disease categories, costs, and insecurity is a relatively new perception of ourselves as inherently ill and in need of chronic treatment.
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