Eyes February roll-out with 10 mn capacity in phase one
CPL Biologicals, a joint venture between Ahmedabad based Cadila Pharmaceuticals and US based vaccine maker Novavax is aiming to roll out 10 million doses of swine flu vaccine (H1N1) in the first phase from January-February next year while it can ramp up the production to 250 million doses over a period of time. CPL Biologicals is creating a manufacturing facility at Dholka for about Rs 100 crore where it will produce for virus-like particle-based (VLP-based) vaccines including H1N1. Currently the company is awaiting a nod from Drug Controller General of India for conducting H1N1 clinical trails.
Talking to Business Standard I A Modi, chairman of CPL Biologicals said, "We have applied for all the requisite permissions and are awaiting nod from the drug control department to carry on clinical trials for swine flu vaccine. Simultaneously, we are preparing for the launch in January-February next year."
Modi said that while they would initially commence the world class facility with a capacity of 10 million doses of H1N1, there is a huge scope for expansion given the demand for the vaccine.
"We can ramp up the production to 250 million doses in a span of 18 months," Modi said. He however refused to comment on the expected revenues saying it was too early to predict. Meanwhile in US, Novavax has shown successful results on a preliminary level of the vaccine during animal testing using new cell-based technology.
The new development is said to have potential to expand vaccine supplies while reducing development time for a vaccine from six months to just one.
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Cadila Pharma has 80 per cent stake CPL Biologicals and the remaining 20 per cent is held by Novavax. Cadila also holds 5.75% equity stake in Novavax of USA and has a position on the board of directors of Novavax.
According to recent union health ministry data, the number of H1N1 cased in India has crossed the 11,000 mark. The flu has so far claimed over 350 lives in the country.
Indian companies Bharat Biotech, Panacea Biotec along with Serum Institute of India conducted animal trials of the H1N1 vaccine in September and are planning to conduct human trials in the first week of October. The vaccine is expected to hit the market early next year.
Three international companies — Novartis, GSK and Baxter — have agreed to initiate a bridge study in India which is expected to start this month.