Sanofi Pulls Out Ahead of Chiron On Bird-Flu Drug
By NICHOLAS ZAMISKA
Staff Reporter of THE WALL STREET JOURNAL
July 25, 2005; Page B3
Sanofi Pasteur, the vaccine unit of French pharmaceutical giant Sanofi-Aventis, is on track to complete work on a human bird-flu vaccine by year end, pulling ahead of rival Chiron Corp., which still is dogged by quality-control problems at its plants.
Results from the first wave of tests on 450 healthy adults in the U.S. could be released as early as today, according to a person familiar with the research, allowing Sanofi to begin seeking approval from the U.S. Food and Drug Administration.
Early indications from those trials suggest people may require two doses several weeks apart, which could make it more difficult to administer on a large scale.
Avian influenza has continued to spread in Southeast Asia. The virus can't pass easily between humans, though scientists have issued repeated warnings that the virus could mutate to a form that could, creating a pandemic.
International health experts say Sanofi is likely to be the first out of a dozen or so companies world-wide to finish its clinical trials of a bird-flu vaccine.
Production of Chiron's vaccine has been delayed by contamination problems. Last October British health authorities ordered Chiron's Liverpool, England, plant to stop production of its standard flu vaccine for the U.S. market. Chiron of Emeryville, Calif., says production is under way on 8,000 doses of the bird-flu vaccine to be used in clinical trials this year.
Meanwhile, smaller players in Asia, including companies in China and Vietnam, are working on their own vaccines. Beijing biotech firm Sinovac Biotech Ltd. said it is testing its own bird-flu vaccine on animals and has nearly doubled spending on the vaccine's development at the behest of the Chinese government, which is eager to foster a domestic supplier.
Like any virus, bird flu can mutate quickly, which could leave the vaccines Chiron and Sanofi are developing ineffective. But by testing the vaccine now and obtaining regulatory approval for their production process, the companies will be positioned to simply swap in new strains for new vaccines.
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Sinovac Biotech Ltd. (SVA)
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