Thursday, October 21, 2004

MedImmune Inc. will provide an additional 1 million doses of its FluMist nasal-spray vaccine this year to help the country overcome a shortage of flu shots, U.S. health officials said yesterday.

That increases to 3 million the number of doses of FluMist that MedImmune, based in Gaithersburg, has promised to make available.

“This is very good news,” Health and Human Services Secretary Tommy G. Thompson said.

The additional doses of MedImmune’s nasal-spray vaccine will help the country cope with the shortage of injectable vaccine, said Lester Crawford, acting commissioner of the U.S. Food and Drug Administration.

FluMist “is for healthy people. This will free up vaccine for others,” Mr. Crawford said.



FluMist vaccine must be stored through freeze-drying and is approved for use only on healthy people between 5 and 49 years old.

MedImmune announced disappointing third-quarter earnings yesterday, even as the outlook brightens for FluMist.

The company reported a third-quarter loss of $65 million, compared with a $16 million loss a year ago.

Nevertheless, demand is strong for its FluMist nasal-spray vaccine as the nation endures a shortage of injectable flu vaccine because of contamination.

“While we certainly don’t welcome the current crisis, we believe the additional usage of FluMist this year does have the potential to accelerate future growth,” David Mott, MedImmune chief executive officer, said during a conference call with investors.

In addition, MedImmune plans to start human trials with a new version of FluMist that is easier to store and can be administered to younger children.

The new version can be stored with simple refrigeration and is being tested for use on children as young as 6 months.

FluMist sales last year fell far short of expectations as the vaccine was introduced to the market, largely because it could not be administered to the elderly, very young or ill. The $46 price tag, about three times higher than an injectable vaccine, also was an issue.

MedImmune manufactured more than 4 million doses but sold only about 450,000. The rest were destroyed. The company’s production facility has the capacity to produce 20 million doses.

MedImmune blamed much of the third-quarter loss this year on the breakup of its deal in April with Wyeth, the company that was supposed to market FluMist. MedImmune expects the contract failure to cost it $138 million this year.

In addition, research and development costs rose to $73 million from $54 million, while sales and administrative costs rose to $68 million from $52 million, mainly from costs of reacquiring FluMist from Wyeth.

Without the Wyeth charges, MedImmune earned $27 million in the first nine months of 2004, or 11 cents per share.

“MedImmune is strong and continuing to build for the future,” Mr. Mott said.

Drug sales rose 12 percent, mostly on strong earnings from the drug Synagis, a treatment for infant respiratory infections.

• Bill Glanz contributed to this report.

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