I wonder what the manufacturing issues are in this article from AOL
Aviron Delays Filing of Flu Vaccine; Shares Fall 15%
Mountain View, California, July 14 (Bloomberg) -- Aviron shares fell as much as 15 percent after the fledgling vaccine maker said it won't file before late September for U.S. approval of its inhaled flu vaccine.
Shares in Aviron, which has yet to win approval for any of its products, fell 4 3/8 to 28 in late morning trading after earlier trading as low as 27 1/2. Yesterday, shares rose 13 percent as investors' expectations were bolstered by a glowing study on the vaccine in today's issue of the prestigious Journal of American Medical Association.
Unresolved issues with the manufacturing of the vaccine mean the company can't say whether it will meet its goal of submitting the application to the U.S. Food and Drug Administration before the North American fall season which begins Sept. 22 -- so that the agency has time to review and potentially approve the vaccine in time for the 2000-2001 flu season, Chairman and Chief Executive Leighton Read said last night.
''It's a realistic goal with considerable risk. There are many things that could cause us to miss that time window. There's no guarantee that we can deliver,'' Read said in an interview.
Indeed, the vaccine has already suffered a series of timing setbacks as the company worked to meet the FDA's requirements for manufacturing quality.
''After a year delay, obviously people are a little bit worried,'' said Carl Gordon, an analyst with Orbimed Advisors. ''If they don't get it filed soon, it would be difficult to get it approved for the 2001 flu season unless it gets fast tracked review,'' at the FDA, he said.
Aviron is working with marketing partner American Home Products Corp. to meet FDA requirements designed to ensure that the vaccine can be made safely and uniformly. Production of the vaccine is complicated by a three-step process. The product must pass through plants in Mountain View, California, and then the U.K. before manufacturing is completed in Philadelphia.
Aviron shares tumbled last year after the agency refused to accept the first marketing application for FluMist, saying the company hadn't provided enough information about how the vaccine is made.
The stock suffered as the company extended its estimate of how long it would take for the manufacturing issue to be resolved. In December, Aviron said it expected that to happen in the summer, which begins June 21, or the fall. Today, it said that won't happen until the fall at the earliest.
''The FDA is justifiably cautious in taking care of the children of America,'' said Richard van den Broek, an analyst with Hambrecht & Quist. Because of the uncertainty around when the vaccine is going to move forward, Aviron's value will likely ''remain suppressed'' until the FDA sends a clear signal that the product is on track, or actually approves the vaccine, he said.
A delay in reaching the market could be particularly bad news for Aviron's vaccine because it will face increasing competition from other drugmakers eager to get in on a market that some analysts say could be worth $2 billion a year.
Gilead Sciences Inc., a biotechnology company based in Foster City, California, is working with Swiss drugmaker Roche Holding AG to win approval of a pill designed to both prevent and treat the flu.
U.K. drugmaker Glaxo Wellcome Plc teamed up with Australia's Biota Holdings Ltd. to develop another flu-prevention product that could be approved in the U.S. in time to be on the market for the coming flu season.
Jul/14/1999 11:54
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