MedImmune posts wider loss, $36 million, for 3rd quarter

Company expects delay in approval of flu vaccine

October 25, 2002|By Julie Bell | Julie Bell,SUN STAFF

MedImmune Inc. reported yesterday that its third-quarter loss widened, partly because of acquisition-related costs, and said it doesn't expect its nasal-mist flu vaccine to be approved until next year.

The Gaithersburg company also cautioned that even if it is approved, the FluMist vaccine that MedImmune has targeted to generate $1 billion annually in total sales within five years might initially be labeled for use only in those older than age 5, which would eliminate about 7 percent of the population for which the company had intended it.

"I think the company may initially accept a somewhat narrower label of [ages] 5 to 50 just to get easier approval from the FDA," said Dennis Harp, an analyst with Deutsche Bank AG in New York.

The company was seeking approval for people ages 19 months to 64 years. Accepting a more-limited age range would temper Food and Drug Administration concerns about possible side effects from the vaccine, which is made with a live virus, analysts said.

The agency is particularly concerned about the potential of side effects such as asthma in young children and potential side effects in older adults with underlying health problems, they said.

An FDA expert panel is expected to discuss the drug Dec. 17 before making a recommendation to the agency.

MedImmune said it lost $36.3 million, or 14 cents a share, on revenue of $72.6 million in the third quarter, which ended Sept. 30. The results include more than $7 million in costs related to MedImmune's $1.6 billion stock acquisition of Aviron, the Mountain View, Calif., developer of FluMist, and a $10.6 million loss on investments.

The results were in line with analysts' estimates, according to a survey of 19 analysts by Thomson Financial/First Call.

The company posted a loss of nearly $19 million, or 9 cents a share, on revenue of $47.4 million for the third quarter a year ago.

MedImmune shares lost $3.05 and closed at $24.30.

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