To: Cytokine1 who wrote (5633 ) 9/18/1998 12:53:00 AM From: Vector1 Read Replies (2) | Respond to of 9719
Aviron says 1999 FluMist launch unlikely By Ransdell Pierson NEW YORK, Sept 17 (Reuters) - Aviron (Nasdaq:AVIR - news) said Thursday that due to continuing regulatory hurdles, there was only a ''low'' probability it would launch its experimental intranasal influenza vaccine, FluMist, by the 1999-2000 flu season. ''What is the probability? I would say low,'' Aviron Chief Financial Officer Fred Kurland told Reuters at the Carson Group biotech conference being held here. The California biotech company submitted a Product License Application in July to the U.S. Food and Drug Administration (FDA) for a marketing approval of FluMist. But Aviron disclosed on Aug. 31 the FDA had refused to accept the marketing application, noting the agency wanted more information on the drug's manufacturing process. At the time, Aviron cautioned that the FDA might require another clinical trial to ensure that a new manufacturing process needed to make large commercial batches of FluMist would yield essentially the same vaccine as the one used in successful earlier clinical trials. Kurland said Thursday that although the probability of a launch in time for the 1999-2000 flu season was low, the company still held out hope and planned to meet with FDA officials in coming months to better determine FDA requirements for accepting Aviron's FluMist marketing application. Aviron previously said a new clinical trial would take at least six months to complete. Although such a trial might delay the FluMist launch to the 2000-2001 flu season, Kurland said such a delay should give Aviron time to ramp up capacity to produce 20 million doses of the vaccine - four times the amount that would be available for a 1999-2000 launch. He added the company was interested in staging a television, radio and newspaper direct-to-consumer advertising campaign in the summer preceding the FluMist launch. ''Probably the ideal time for the flu vaccine to be taken is September, when kids find themselves in closed classrooms starting to give each other the flu,'' Kurland said. ''So I would think August would be a good month'' to launch an eventual direct-to-con