MedImmune given OK on FluMist plant


December 28, 2005|By BLOOMBERG NEWS

WASHINGTON -- MedImmune Inc. said yesterday that U.S. regulators approved its new British manufacturing plant for making the FluMist influenza vaccine in 2006, when the company expects an easier-to-use version to be approved for sale.

MedImmune, which is supplying 3 million doses of FluMist this year, will be able to produce up to 15 million doses a month with the new plant in Speke, England, the company said. MedImmune will start making FluMist in 2006 at the plant, which also might be used to make a version now under regulatory review and to produce vaccine for a potential flu pandemic, the company said in a statement.

MedImmune, based in Gaithersburg, wants to replace FluMist with a version called CAIV-T that the company expects will be approved next year for the 2007-2008 flu season. CAIV-T can be kept refrigerated instead of frozen, making it easier to store and distribute, and has shown greater effectiveness than a shot against some forms of influenza.

"With this state-of-the-art facility, we can substantially ramp up production," said Bernardus N.M. Machielse, MedImmune's senior vice president of operations, in the statement. "The approval of our new manufacturing facility demonstrates MedImmune's ongoing commitment to being a worldwide leader in the influenza vaccine market."

FluMist, taken as a nasal spray, generated $54 million in revenue last year, about 3 percent of all flu-vaccine sales.

Shares of MedImmune fell 48 cents, or 1.3 percent, to close at $35.80 yesterday on the Nasdaq stock market.

Vaccine makers have been under government pressure to increase capacity on concerns as a result of concerns that the H5N1 bird flu might become a global pandemic.

The new plant, which the company said could also be used year-round to produce vaccine for a potential flu pandemic, is 10 times larger than MedImmune's existing manufacturing facility in Speke. The plant also will use a new filtration process that the company said will provide greater sterility assurance.

The new version of FluMist was more effective than standard flu shots in a study of 8,492 young children, MedImmune said Dec. 12. Results also showed CAIV-T was more effective than a shot against strains of the flu virus not matched to the vaccine.

The findings might help expand the company's share of the market for flu vaccines with an alternative that would spare children the pain of a shot.

FluMist is approved for healthy people ages 5 to 49. Both formulations contain weakened live viruses instead of killed viruses used in flu injections.

The new plant does bulk manufacturing of the vaccine in a process that begins at the company's facilities in California, said spokeswoman Jamie Lacey.

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