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Approval Delayed on Inhaled Vaccine

Pharmaceuticals: FDA has 68 questions on clinical and manufacturing data for MedImmune's FluMist.


The approval process for the first inhaled flu vaccine received another setback Thursday as the government sought more information about it from drug maker MedImmune Inc. The development means that FluMist may not make it to market by this flu season.

In a conference call with analysts after the markets closed, Chief Executive David M. Mott said the Food and Drug Administration had 68 questions on manufacturing and clinical data submitted about FluMist. Mott said most questions were minor and the company was optimistic that it could respond within the next 30 to 45 days.

But Mott refused to handicap FluMist's chances of reaching the market by mid-November. Last winter he said the product had a 50% to 50% chance of reaching the market for the 2002 flu season.

"Timelines for launch this year are tight," he said.

Mott did say he was confident the product would be approved and available for the 2003 season.

MedImmune received FluMist as part of its $1.6-billion acquisition of Menlo Park-based Aviron in November. Aviron, now called MedImmune Vaccines, submitted its application to the FDA in October 2000. Last summer, a government review panel raised numerous safety questions about the drug, which uses a live influenza virus and is squirted into the nose. Other vaccines use a dead virus.

Mott said the FDA still had questions about the safety of using the vaccine in children younger than 3, particularly those who have asthma. The agency is concerned about an elevated incidence of asthma and wheezing in asthmatic toddlers who tried the vaccine, he said.

Mott said the company may not be able to market the vaccine to children younger than 3, a key group for the vaccine. However, Mott said that they account for just 6 million of the 174 million potential users of the vaccine.

On the manufacturing front, the FDA has questions about MedImmune's plans for quality testing, Mott said.

The company is continuing to gear up for the coming flu season in the hope that the product will be approved in time. It is continuing to manufacture the drug, and with its marketing partner Wyeth, is putting its sales force in place. MedImmune said it has the capacity to sell 4 million doses of vaccine this season.

MedImmune hasn't said what it will charge, but analysts expect it will be more than the standard $10 charged for a flu shot. The company has told analysts that it believes the social costs of the flu work out to $28 to $40 a dose.

FluMist is important to MedImmune. The company posted a $1.1-billion loss in the first quarter due to a $1.2-billion charge on the Aviron acquisition.

Shares of Maryland-based MedImmune rose $3.36 to close at $24.46 on Nasdaq on news that the FDA did not ask for additional clinical trials.

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