Cadila Pharmaceutical Limited, an Ahmedabad-based unlisted pharma major, hopes to be the first to launch the vaccine for swine flu virus H1N1 by November this year.
CPL had set up a joint venture (JV) on July 9 with the US-based vaccine maker Novavax for manufacturing of vaccines, including one for swine flu. The JV company called CPL Biologicals Pvt Ltd is filling application with Drug Controller General of India (DCGI) this week for phase one clinical trial for swine flu vaccine.
Company officials were confident Cadila will be the first Indian pharma company to produce the swine flu vaccine. “Novavax has already received permission for pre-clinical trials from US Federal Drug Administration,” IA Modi, chairman and managing director, CPL.
Modi said the vaccine is expected to be available in November 2009 if permission for clinical trial comes from the government immediately. The government has already decided to clear swine flu related applications on fast track basis.
Modi said to protect from swine flu pandemic, two dosages of the vaccine are required over two weeks. The company initially intends to produce 2 million vaccines on a monthly basis and scale up production to cater to global demand, Modi said. “Sky is the limit as far as production is concerned,” he said.
The JV has already started building a facility costing Rs 100 crore in the CPL campus at Bhat to produce the vaccines. The new facilities will be operational after one-and-a-half years but the company will be able to launch the vaccine in November, using existing manufacturing capacity of CPL.
CPL has 80% equity and Novavax 20% in the JV. It may be pointed out that Cadila Pharma also holds 5.75% equity stake in Novavax Inc USA and has a position on the board of directors of Novavax.