16-30 N ovember 2012 I Vol 1 I N o 10 I `100
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Ganesh Sambasivam Co-Founder & CSO, Anthem Biosciences
Roche’s Avastin wins EU approval
Roche’s Avastin won EU approval for use in the treatment of recurrent, platinum-sensitive ovarian cancer. The drug is already cleared by EC, for use in combination with gemcitabine and carboplatin to cure patients with first recurrence of platinum-sensitive ovarian cancer. The additional clearance of Avastin is important for ovarian cancer for patients that are now able to obtain Avastin along with chemotherapy in case of recurrence. EU approval was supported on the phase III OCEANS study, which reflected that the patients with recurrent, platinum-sensitive ovarian cancer who were on Avastin along with chemotherapy lived longer without any serious progression in comparison to the those who obtained only chemotherapy.
Big pharma cos behind campaign against tobacco: ITGA
International Tobacco Growers Association (ITGA), which opposes some of the articles of World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC), has alleged that big pharmaceutical companies are behind the campaign. It said this was to reduce cigarette production and thereby increase nicotine patch sales, which is used to help people quit smoking. The FCTC has been adopted by 176 countries, including India since its inception in 2005. The measures are aimed at promoting alternatives to tobacco growing, production, besides reducing the acreage of plantation. India is also one of the countries that has adopted the FCTC.
Scientists test 5,000 combinations of 100 existing cancer drugs to uncover more effective treatments
Scientists in the US have tested all possible pairings of the 100 cancer drugs approved for use in patients to discover whether there are any combinations not tried previously that are effective in certain cancers. Dr Susan Holbeck, a biologist in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (USA), and her colleagues have completed testing the 100 drugs, with 300,000 experiments to test the 5,000 possible drug combinations in a panel of 60 cell lines developed by the National Cancer Institute (NCI-60 panel). “The goal is to identify novel drug combinations that are more active than the single agents alone. Since these are all approved agents, there is the potential to rapidly translate these combinations into the clinic,” she said.
Special Focus 26 Policies & Regulations 28 Loopholes in the QA & QC system Need to clear the ambiguities
Orphan drugs for orphan diseases How the concept is ‘orphan’ in India?
Case study 31 Benefits of ‘Machine Vision’ Helping Indian manufacturing to be globally competitive
Construction started for Novartis’ Singapore facility Novartis recently announced the construction of a new state-of-theart biotechnology production site in Singapore with an investment valued at over $ 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology. It will be co-located
Jimenez
with the pharma production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence center for both biotechnology and pharma manufacturing at Novartis. “This investment further strengthens our strategy to establish key strategic sites based on technological competencies. Singapore will be strengthened through a new state-of-the-art facility for biotechnology, which is a growing segment of our business,” said Joseph Jimenez, CEO, Novartis. “We have chosen Singapore as strategic supply point as it offers a wide range of advantages due to its strong local biomedical presence and knowledge, skilled labour as well as proximity to growth markets in Asia.”
The investment decision underlines the long-term strategy of Novartis to establish a worldwide manufacturing network of technology centres of excellence. The groundbreaking for the new production site is scheduled for the first quarter of 2013, while the new facility is expected to be fully operational by the end of 2016. The site will be designed to operate in a flexible manner to handle small and large scale volumes. Further, it is planned to support both clinical and commercial production of potential new products that include monoclonal antibodies for use in helping patients with diseases in autoimmune, respiratory and oncology indications. The biologics pipeline currently accounts for 25 per cent of the clinical pharma research pipeline with a trend for future growth.
IAIA elects new team Indian Analytical Instruments Association has elected its new executive member committee. K V Venugopalan has been elected as the new President, who is also the President of Waters India Pvt Ltd; while C Ravindranath and Dr Ashes Ganguly will take over as Vice President. New IAIA secretary position would be held by Gautam Rajan, existing MD of Marsap Services Pvt Ltd; Vipul Chhatbar, the acting MD of MEDISPEC INDIA LTD
and BioTek Instruments (I) Pvt Ltd will be the new Treasurer for IAIA. Current CEO Skytech Systems India Pvt Ltd will take over as Joint Treasurer. IAIA team comprises total 78 members, including 59 corporate life members and 19 individual life members from various organisations such as Perkin Elmer, Lab India, Cryogen, Spinco, Dionex, Ind tech, Thermo Fisher Scientific, Ranbaxy Fine Chemicals and Waters etc.
Venugopalan
Piramal in pact with Fujifilm Piramal Enterprises’ Healthcare vertical has entered into a strategic alliance with Fujifilm Diosynth Biotechnologies. The two parties will offer seamless contract development and manufacture Antibody Drug Conjugates (ADCs), a growing niche in the development of biopharmaceuticals. The deal will allow customers to benefit from the experience and assets of both organisations, while simplifying the supply chain and vendor management Shah relationships, leading to shorter time to clinic. Piramal is a world leader in antibody drug conjugation, while Fujifilm Diosynth Biotechnologies is one of the
world’s leading providers of contract development and manufacturing services for biopharmaceuticals. The combined experience covers work on more than 150 biopharmaceuticals and over 300 batches of ADCs spanning over more than 30 different NCEs, including the world’s only FDA-approved ADC. For Fujifilm Diosynth Biotechnologies, this is part of an ongoing programme to expand its offering in mammalian-based biopharmaceuticals. The company recently announced an expansion of its cGMP manufacturing facilities at both its RTP, USA and Billingham, UK sites.
Vijay Shah, Executive Director & COO, Piramal Enterprises said, “We are delighted to join with Fujifilm Diosynth Biotechnologies to offer a seamless service to customers for the production of antibody conjugates. Fujifilm Diosynth Biotechnologies has a long track record in delivering successful biologics programmes, and this alliance will combine strengths from both companies for the benefit of our customers, and ultimately patients.” Stephen Taylor, Commercial Vice President, Fujifilm Diosynth Biotechnologies, said, “This strategic alliance with Piramal is an important step for us in bringing a new, hightechnology offering to the market place. Our customers will benefit from high quality, consistent material, rapid service and shorter logistical chains, saving time on the critical path of drug development. Piramal is a recognised world leader in this area and we are delighted to be partnering with them.”