June 12, 2009...1:48 pm

Novartis Ahead Of Pack – First Swine Flu Vaccine

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    In the race to cash in on the rapidly-growing market for swine flu treatments, Novartis has emerged as the surprise front runner for a vaccine. The Swiss drugmaker said Friday that it had produced a first batch of experimental vaccines to fight the H1N1 flu outbreak, and expected to ramp up manufacturing quickly thanks to a newly-discovered manufacturing method.

The breakthrough comes a day after the World Health Organization declared a swine flu pandemic, increasing its alert to the maximum level.

All major drugmakers received the H1N1 wild-type strain from the WHO two weeks ago to enable them to develop the vaccine, but Novartis is the first one to have said it will have the vaccines ready but this fall. Novartis said its research showed that it was quicker to make the vaccine through cell-based production, rather than traditional egg-based manufacturing.

“Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations,” Novartis said, adding it expected to get a license for the vaccines from the World Health Organization in the autumn.

Cell-based manufacturing technology allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies, the drugmaker said. “This advance has cut weeks off the time required to begin vaccine production.”

The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September.

Novartis. expects clinical trials to start in July.

The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week.

Novartis said more than 30 governments have requested vaccine supplies, including the U.S. Department of Health and Human Service, which placed a $289 million order in May.

Sources: www.forbes.com, www.localtechwire.com

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