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Cadila to Seek Approval for Swine Flu Vaccine Trials

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Cadila Pharmaceutical will file with the DCGI within two days to begin phase-I trials of an H1N1 swine flu vaccine, aiming for a December launch in India.

Cadila Pharmaceutical plans to approach the Indian government within the next two days for permission to begin clinical trials of a vaccine against the H1N1 swine flu virus. The company intends to file its application with the Drug Controller General of India (DCGI) to start phase-I testing, chairman and managing director I A Modi said in New Delhi.

The vaccine effort is being run through CPL Biologicals Pvt Ltd, a joint venture Cadila set up with US firm Novavax to develop and manufacture a range of vaccines in India, including one for swine flu. Cadila holds an 80 per cent stake in the venture, with Novavax owning the remaining 20 per cent.

Modi said Cadila expects to become the first Indian pharmaceutical company to bring a swine flu vaccine to market. He set a target of December this year for a launch, provided the DCGI grants clearance quickly and the company can draw on technology from its US partner.

Novavax has already secured clearance from the US Food and Drug Administration to conduct its own trials. Modi said that once Cadila obtains Indian approval, both sets of trials could run at the same time.

The company's current facility can turn out up to one million doses of the vaccine each month, a figure that could be raised to two million doses. Modi said full protection against the swine flu pandemic requires two doses, given over a two-week period.

The joint venture has begun constructing a new plant backed by an estimated investment of Rs 100 crore. Modi added that the government has signalled it will process swine flu-related applications on a fast-track basis, and the company is hopeful of rapid approval.

Beyond the joint venture, Cadila also owns a 5.75 per cent stake in Novavax Inc in the United States and holds a seat on the American company's board of directors.

Cadila Pharmaceutical, swine flu vaccine, H1N1 vaccine India, Novavax, CPL Biologicals, DCGI clinical trials, influenza vaccine

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