Cadila to apply for clinical trials for swine flu vaccine – Times of India

New Delhi: With the aim of launching a vaccine for influenza H1N1A virus (swine flu) in India, Cadila Pharmaceutical will seek government permission in two days to start clinical trials in this regard.
Cadila Pharmaceutical Limited (CPL) had set up a joint venture ‘CPL Biologicals Private Limited’ with US-based vaccine manufacturer Novavax to manufacture and develop several vaccines including swine flu in India.

CPL chairman and managing director IA Modi said, “The joint venture is going to file an application with the Drug Controller General of India (DCGI) for the first phase of clinical trials for the swine flu vaccine in the next two days.”
Modi expressed confidence that Cadila will be the first Indian pharma company to launch a swine flu vaccine in India by December.

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Modi said, “If we get DCGI’s permission soon, with the advanced technology available from our partner, (we) will be able to launch it in India by December this year.”

Modi said that with its existing facility, Cipla can produce one million doses of vaccine per month, which can be increased to two million doses.

“Novavax has already received permission from the US Federal Drug Administration for clinical trials and if we get it soon, we can start the trial together,” he said.

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Modi said that the government has already indicated that applications related to swine flu will be approved expeditiously and the company hopes to get immediate approval for the same.

He said that two doses of the vaccine were required in two weeks to prevent the swine flu epidemic.

The joint venture has already started construction of a facility with an estimated investment of Rs 100 crore. Cadila holds an 80 percent stake in the joint venture and Novavax holds the remaining 20 percent.

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In addition, Cadila Pharma also holds a 5.75 percent stake in Novavax Inc. US and holds a position on the board of directors of the US-based company.

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