Novavax reports good results from swine flu vaccine

Tuesday, September 1, 2009, 12:21pm EDT | Modified: Wednesday, September 2, 2009, 3:08am

Washington Business Journal - by Vandana Sinha Staff Reporter

Novavax Inc. reported positive results from a mid-stage clinical trial of its vaccine technology for three flu strains, including the H1N1 strain more commonly known as the swine flu -- news that sent the Rockville biotech’s shares up to a new year-long high.

The company, which produces flu vaccines by using virus-like particles rather than the traditional approach of growing an entire live virus strain in an egg, said its method held up safely and effectively in a three-month clinical trial involving 221 volunteers ranging from 18 to 49 years old.

Novavax (NASDAQ: NVAX) said volunteers who experienced high immunity responses to its VLP vaccine ranged from 81 percent to 86 percent of its group for one seasonal strain called H3N2, from 57 percent to 66 percent for the H1N1 strain and from 62 percent to 67 percent for a third seasonal flu strain. Those results met Food and Drug Administration standards for such treatments, the company said.

Novavax, which has already been attracting attention for its technology as a possible answer for the swine flu, boosts those prospects with these results. Though its product is still likely years from potential federal approval, in part causing the company to look at international deals like with recent partner, Madrid-based Rovi Pharmaceuticals Laboratories, to jointly develop and produce the product. “We are working tirelessly with partners and governments worldwide to potentially provide H1N1 vaccine to regions without an indigenous supply,” said President and CEO Rahul Singhvi.

In particular, Novavax said its technology measured better in guarding against the H3N2 strain, which it said didn’t grow well in eggs, when compared to Fluzone, an established egg-based vaccine sold by mega-vaccine maker Sanofi Pasteur SA. But the local company didn’t give further details, saying it measured that comparison separately on a 20-person group, too small to make any conclusions. Instead, Novavax said it’s starting a head-to-head study on elderly volunteers this winter to compare its VLP technology with egg-based alternatives.

Novavax said it plans to take its seasonal flu vaccine candidate into the third and final stages of study next year.

The company’s shares leapt as much as 29 percent in trading Tuesday to a new 52-week high of $7.79 before settling by noon to $6.73, up 69 cents and 11 percent from Monday’s closing price.

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