16 -31 Augus t 2013 I Vol 2 I N o 4 I `10 0
www.modernpharma.in
In Conversation With 12
Special Focus 14
Special Focus Roundtable 18
Insight & Outlook 20
Georg Sparschuh President, Schott Glass India Pvt Ltd
Clinical trials and research How to sustain growth momentum in India?
Do we need stringent regulations to streamline CRO operations?
Policies & Regulations FDI in pharma: Apprehensions deter growth prospects
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Biocon delivers a healthy business growth rate iocon’s revenue growth in Q1 FY’14 reflected strength of its product portfolio. The biopharma business grew by 21 per cent year-on-year to ` 439 crore. The branded formulations grew by 17 per cent year-on-year to ` 101 crore, while research services, Syngene and Clinigene grew by 26 per cent to yearon-year to ` 155 crore. Group Earnings before Interest, Taxes, Depreciation, and Amortization (EBITDA) and Profit after Tax (PAT) margins were at 24 per cent and 13 per cent respectively. Biocon made an R&D investment of ` 43 crore. Commenting on the results, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, “We are pleased to report a strong set of numbers for Q1 FY’14. The new organisational structure has enabled us to deliver superior results with the core business performing
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strongly. Biocon’s insulin business continues to do well, riding on the back of an increased geographical footprint in the emerging markets. India-focussed branded formulations vertical as well as the research services divisions continue to grow at a steady pace. Our research programmes are making good progress. I am very excited about the upcoming launch of Alzumab®, our second novel biologic. We look forward to bringing this first-in-class molecule for the treatment of psoriasis to the Indian market. The current fiscal will see us consolidate our various initiatives whilst we continue our investments in our biosimilars and novel molecules, to deliver a sustainable growth platform. ” Biopharma’s sales grew 19 per cent year-on-year at Constant Exchange Rate (CER), with broad based growth across the small molecules and biosimilars portfolio. The small molecules
Snippets
Dr Reddy’s launches Donepezil Hydrochloride tablets
Dr Reddy’s Laboratories announced launch of Donepezil Hydrochloride tablets, 23 mg, a therapeutic equivalent generic version of ARICEPT®, 23 mg in the US market on July 26, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr Reddy’s Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride tablets, 23 mg. The ARICEPT®, 23 mg brand had US sales of approximately $ 92.6 million for the most recent twelve months ending in May 2013 according to IMS Health. Dr Reddy’s Donepezil Hydrochloride tablets, 23 mg is available in bottle count sizes of 30 and 90.
portfolio delivered a strong performance this quarter, led by immunosuppressants and specialty molecules like Fidaxomicin and Orlistat. The statins portfolio has remained stable, despite the changing market dynamics.
Kiran Mazumdar-Shaw
Commenting on the biopharma business performance, Arun Chandavarkar, Chief Operating Officer, Biocon said, “The sustained growth in our small molecules business reflects the robustness of our diversified and differentiated portfolio. Commercialisation of insulin in emerging markets continues to be a significant growth driver and we are on track with capacity expansions
to address these medium term opportunities. We remain focussed on developing our pipeline of products that address significant global opportunities across our business segments to sustain longterm growth.” Commenting on the current landscape and the vertical’s performance, Rakesh Bamzai, President-Marketing Biocon, said, “Biocon’s branded formulations business has created a significant presence in the Indian pharma market with our top of the line quality products, by focussing on patients’ therapeutic needs and driving better patient compliance to treatment regimes. Although there are challenges in the industry due to recent changes in the pricing guidelines, we are optimistic that the branded formulations business will overcome these challenges and continue to register high growth by improving market shares on existing products supported by the launch of new products.”
Strides Arcolab receives approval for Tenofovir Disoproxil Fumarate and Emtricitabine tablets Strides Arcolab Ltd has received a tentative approval from the USFDA for its antiaids combination drug, Tenofovir Disoproxil Fumarate and Emtricitabine tablets, 300mg and 200mg. The company is among the six generic companies to have received the USFDA approval. This Abbreviated New Drug Application (ANDA) has been reviewed under the expedited provisions of the President’s
Emergency Plan for AIDS Relief (PEPFAR). The company supplies Antiretroviral drug (ARV) products to global procurement agencies and this approval adds to the overall basket of medicines available.This combination drug is the generic equivalent of Gilead Sciences Inc’s Truvada tablets and falls under the ARV segment. It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.
Editor’s Pick 16 Special Focus
M o d e r n P h a r m a | 16-31 August 2013
Clinical research in India
What is at stake?? Clinical trials in India have always remained under lens byy various expert committees and several healthcare stakeholders,, with a continuous demand and scope for improvement at thee operational level. This part of the drug development process iss now being seriously attended by experts and strict adherencee to the standard guidelines is being practised across the country,, with significant efforts from the researchers and policymakers. linical research is an indispensable part of the drug discovery process and clinical trials form the mainstay for bringing new and better drugs to the market. India has become an important hub for pharmaceutical drug discovery and development process for a variety of reasons. The country is an attractive destination for conducting clinical research because it has an appropriate environment and requisite facilities such as large patient population, diverse ethnic and genetic makeup, speciality hospitals with good infrastructure, good investigators and medical staff with English speaking professionals and above all, lower operational costs. The fundamentals are in place to enable pharmaceutical/ biotechnology organisations, academia and medical institutions to outsource trials to India. India continues to be a potentially an ideal hub to undertake and conduct ethical and good quality clinical trials.
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Seemant Jauhari Chief Executive Officer, Apollo Hospitals Educational and Research Foundation seemant.j@aherf.net
Conducting clinical trials is a scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. India: A clinical research hub Due to the key success factors at a macro-level being in place, clinical research is now perceived as a new service growth engine, which could contribute significantly to the global requirements of the drug discovery process. This has resulted in a swift uptake of clinical research in India dovetailed with some hype as well. While growth momentum on this front, provided opportunities to home-grown talent, the regulations, selfgovernance, infrastructure and mindset of the populace are not in sync with the demands of the evolving segment. While, a majority of stakeholders
undertook clinical research responsibly, the mismatch in pace has allowed several players to perceive this opportunity as a transactional one. This sub-section lacked appropriate processes, governance and mindset to take on clinical research responsibly, thereby resulting in adverse events. Over the last few years, India has been witnessing an increasing number of controversies with consequent negative publicity and adverse developments in clinical research. The controversies emanated from a host of issues related to ethics, law, human rights and scientific development, lack of information and training, regulation etc. This has been exaggerated by the lack of understanding of clinical research in general, the negative general public perception and the consequent political reactions. A few defaulters have been responsible for tarnishing the image of the whole industry, which by and large operated to the international standards. The Supreme Court has taken an extremely serious view of the 2,868 deaths that have been reported during the period 2005-2012 due to clinical trials. There have been several queries and opinions exchanged among key stakeholders regard the composition of ethics committee, their registrations and the compensation for patients participating in the clinical trials, the process of informed consent especially for Bachelor of Engineering (BE)/ Bachelor of Arts (BA) studies, which has further reduced the clarity on the subject. Impact on India The intervention of the Supreme Court has triggered a chain of events, which may lead to the much needed regulatory reform. At the same time, it has also temporarily but significantly slowed down trial approvals in India. As a result, till April 2013, only 12 clinical trials have been approved by the authority, as compared to almost a three-digit figure last year. Currently, the clinical
research industry is viewed with scepticism, fear and uncertainty. Few trials are being conducted, patients are fearful, the regulatory reform is sluggish and the industry perception is overall sceptical. On the other hand, there is an impending positive impact generated by a collective debate through various forums on means to internally improve the standards and governance for undertaking clinical trials. One of the key takeaways from the resulting debate is the need for a greater role of the ethics committees in conducting clinical trials. There is an urgent need for training programmes at various levels to increase the pool of competent ethics professionals. A wide representative group of industry, academia and regulator is required to champion established benchmarks of international standards and the good news is that this process has begun informally at various levels. The emphasis on laws governing the functioning of ethics committee and important issues such as compensation to patients, in case of adverse events is now even more critical for the future of clinical research. This need is now being addressed carefully by the regulator through a consultative process with the relevant stakeholders. Overall, the stakeholders have been prompted to pause, review the current status, formulate solutions for improvements and support creation of a robust plan for the future. What is at stake? Owing to excessive reactions to the adverse reports, the regulatory reform process has been slow, thus leading to uncertainty. The large and established organisations have little clarity regarding the timelines, with respect to the reforms being put in place. Due to lack of consistency on the regulatory front over the last 2 years, reputed organisations have become hesitant regard expansion and are even considering temporary
reduction of their operations. Also, drug innovators have temporarily stopped and are being sceptical about outsourcing trials to India, until the situation improves. In fact, the pharmaceutical, biotech companies and Clinical Research Organisations (CROs) are considering completion of global studies in new destinations such as Malaysia, Thailand, etc. This downward trend in trials will result in low exposure of clinicians to new and advanced drugs, hence lower availability of new treatments to Indian patients. Only after trials are being conducted and behaviour of new treatments and drugs in controlled conditions are learnt, would clinicians be convinced and recommend these drugs further for better treatment of Indian patients. Also, the vision of India as a global destination for clinical research will be at stake and the country will lose its attractiveness, despite having a talented resource pool and good infrastructure. What the future beholds? Conducting clinical trials is a very scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. The adverse consequences that are surfaced have largely been due to a minority subset of defaulters and the entire industry should not be viewed with the same lens. However, the recent controversies and negativity cannot be wished away. It may prove good in the long term, if it brings about a reform in the process of undertaking clinical trials in India. All stakeholders are hopeful that this churning would result in a comprehensive process for clinical trials, which is effective yet efficient. Such an evolution is much needed for ethical, sensitive, well meaning and sophisticated clinical research in India..
Lupin gets USFDA nod for heart disease drug rug major Lupin has received the US health regulator’s approval to market generic version of Gilead Sciences, Ranexa® tablets, a drug used to treat heart disease in the American market. The company’s US-based subsidiary Lupin Pharmaceuticals, Inc has received final approval for the ranolazine extended-release tablets, 500 mg and 1000 mg from the United States Food and Drugs Administration (USFDA), according to a statement by Lupin Ltd. “Lupin believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Ranexa® extended-release tablets of 500 mg and 1000 mg strengths and as such will be entitled to 180-days of marketing exclusivity,” it added. Ranolazine extended-release tablets are indicated for treatment of chronic angina. According to IMS Health data, the tablets posted sales of around $ 443.4-million in the US for twelve months ending March, 2013.
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