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Zydus starts phase II & III trials for H1N1

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Ahmedabad based pharma major has commenced the phase II and III of the clinical trials of its H1N1 vaccine as the first company in the country, while its competitors are close on its heels to come up with respective vaccines.

The multicentric trials will extend for a period of six weeks and are currently underway at Ahmedabad, Bangalore, Jaipur and Pune. A company spokesperson said that the group will be submitting the results to the Drug Controller General of India (DCGI) for marketing approvals after successful completion of the phase II and III trials. She declined to give out details on the likely pricing of the vaccine saying that will only be decided close to the launch. The vaccine can be expected to be available in market by May if the company gets a DCGI nod soon after completing the trials.

Among other indigenous players, (SII) has also started phase I clinical trials for their H1N1 vaccine. and together with Cadila Pharmaceuticals are working on developing in house vaccines. Cadila Pharma, an Ahmedabad-based pharma company which had tied-up with US-based biotech firm Novavax for rolling out the vaccine in India is yet to get approval from DCGI.

Zydus has already invested Rs 80 crore to develop the vaccine. Pankaj Patel, chairman and managing director, Zydus Cadila had earlier indicated to Business Standard that the company would invest another Rs 50 crore on clinical trials and on expanding its Moraiya facility to eventually produce 12 million doses of the vaccine. The company will initially roll out 6 million doses of the vaccine in the initial phase.

The demand for the H1N1 vaccine is expected to be around 60-80 million doses in India, and that the company would focus on marketing the product in India initially. It has so far claimed 1300 lives in the country with the total number of laboratory confirmed cases crossing the 25,000 mark, a company release claimed.

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