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| Panacea close on Zydus' heels |
| Sohini Das / Mumbai/ Ahmedabad Apr 28, 2010, 00:25 IST |
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Expects full licensure of Pandyflu by July
The race for the finishing line to launch the indigenous H1N1 vaccine seems to be getting intense as Delhi based Panacea Biotech expects to get full licensure of its vaccine Pandyflu by July this year.
Panacea Biotech is initiating phase III trials by the end of this week, Rajesh Jain, joint managing director of the company informed. "We expect licensure of Pandyflu by July 2010 post submission of phase III data", he added.
Big ticket firms like Zydus Cadila plan to roll out the vaccine before the monsoons. The Ahmedabad based pharma major has commenced the phase II and III of the clinical trials of its H1N1 vaccine in March as the first company in the country.
Among other indigenous players, Serum Institute of India (SII) has also started phase I clinical trials for their H1N1 vaccine. Bharat Biotech and 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, however, yet to get approval from DCGI for its virus-like-particle (VLP) technology based vaccine.
Panacea has invested close to Rs 100 crore to set up a 45 million dose per annum facility at Lalru in Punjab for the Pandyflu vaccine. Pandyflu is an inactivated split version vaccine using egg-based technology.
The company has also entered into an advance marketing agreement with Ministry of Health and Family Welfare (MHWF) for supplying its H1N1 swine flu vaccine Pandyflu. The Union ministry of health and family welfare has been discussions with indigenous vaccine manufacturers to assess their capacity to develop, manufacture and supply H1N1 swineflu vaccine for national programme. Talking about the initial roll out volumes for Pandyflu, Jain told Business Standard that "We are working very closely with Ministry of Health and Family Welfare for arriving at volumes and are looking forward to hearing from them".
The market size for the swine flu vaccine in the country is estimated to be around 80 million doses and the estimated global market size of HINI vaccine is close to $ 6.5 billion. Jain said that the company is actively working on preparing necessary documentation required for exporting the vaccine to Latin American and African countries, but exports would be undertaken once Indian requirement have been met.
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.
Swine flu has so far claimed 1300 lives in the country with the total number of laboratory confirmed cases crossing the 25,000 mark.
In December, India placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine.Currently, the imported H1N1 swine flu is priced around Rs 300-400.
But H1N1 swine flu vaccines produced by Indian companies could be priced around Rs 50-100, sources indicated.
The H1N1 influenza or swine flu infections could continue in India for one more year.
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