Aviron updates FluMist BLA plans

AVIR plans to submit a BLA for its FluMist intranasal influenza vaccine in the fourth quarter, in line with the company's previously announced target launch for the 2001/2002 flu season. In 1998, AVIR received a refusal-to-file letter from the FDA citing a need for more manufacturing information (see BioCentury Extra, Sept. 2, 1998). Last fall, the company announced it would not submit the BLA in 1999 due to inconsistent test results during validation. AVIR said the inconsistencies were associated with certain assays and not with the product or its manufacturing process. The company and its partner Wyeth Lederle Vaccines (Philadelphia, Penn.) said they are addressing these issues for consistent assay performance at the commercial scale.

AVIR also said that its contract manufacturer, Celltech Medeva, a business of Celltech Group (LSE:CCH; CLL), is working out compliance issues with the FDA associated with inadequate validation of utility systems in Medeva's Liverpool facilities. These systems are used in the manufacturing of FluMist. ...