Aviron Requests FDA's Approval of FluMist Vaccine (Update1)
10/31/00 5:56:00 PM
Source: Bloomberg News
(Adds comments from CEO beginning in the third paragraph.)
Mountain View, California, Oct. 31 (Bloomberg) -- Aviron said it filed an application with the U.S. Food and Drug Administration for approval of a nasal-spray flu vaccine it developed with American Home Products Corp.
The filing is Aviron's second for FluMist. The FDA refused to accept Aviron's first application, filed in July 1998, saying it needed more information on manufacturing. Late last year, the company again delayed the application.
FluMist may be available for the 2001-2002 flu season, if it wins approval, said Aviron Chief Executive C. Boyd Clarke. The company's shares have more than quadrupled this year in anticipation of the drug's introduction. FluMist would be Aviron's first product.
''Our objective is to try to get it out as soon as possible,'' Clarke said, adding that Aviron has already begun manufacturing the drug for commercial sales.
Aviron will receive a payment of $15.5 million from American Home once the FDA accepts the application for review, Clarke said.
The company announced the filing after the closing of U.S. markets. Aviron shares today rose 94 cents to $65.38. Earlier, the shares touched a 52-week high of $68.25.
Mountain View, California-based Aviron has other products in development, including a liquid version of FluMist that can be stored in a refrigerator. The form being submitted for approval must be stored in a freezer. The liquid version is in the last phase of testing generally required for approval by the FDA.
Aviron is developing vaccines against such viruses as Epstein- Barr, a cause of infectious mononucleosis, and cytomegalovirus, a cause of birth defects. |
