MedImmune drug is OK'd for sale in Canada

Approval is a formality

little revenue rise foreseen

May 29, 2002|By Julie Bell | Julie Bell,SUN STAFF

MedImmune Inc. said yesterday that its top-selling drug, Synagis, was granted approval in Canada, reinforcing an extensive list of countries in which MedImmune marketing partner Abbott Laboratories can sell the drug, which is designed to prevent a respiratory infection in infants.

Analysts said the approval was largely a formality and would result in little additional revenue for the Gaithersburg company.

Synagis has been available in Canada under a special access program since 1998, when the U.S. Food and Drug Administration approved it.

"It's not a real big deal from an incremental standpoint," said Ron Renaud, an analyst with Bear, Stearns & Co. Inc. "Doctors in Canada [already] were allowed to use Synagis."

MedImmune investors instead are anxiously awaiting an FDA decision on whether to approve FluMist, which would be the first nasal-mist vaccine for influenza in the United States.

MedImmune acquired the drug in January along with its owner, Aviron of Mountain View, Calif. MedImmune projects that FluMist could account for up to $500 million of its annual revenue within five years after going on the market.

But that is far from a certainty. The FDA is expected to respond by July 10 to an extensive filing MedImmune made in response to an FDA request for more manufacturing and clinical information on FluMist.

Stefan D. Loren, an analyst with Legg Mason Wood Walker, expects FluMist to be approved late this year or during next year.

For now, Synagis remains the main driver of MedImmune's fortunes. The drug accounted for $293 million of the company's $320.7 million in product revenue in the first quarter. MedImmune sold $516 million worth of Synagis to wholesalers and distributors last year.

The company has said that it expects worldwide sales of Synagis to increase as much as 23 percent this year, up to $635 million.

Analysts said about $40 million of that revenue should come from sales outside the United States by Abbott Laboratories. At least 47 countries, in addition to the United States, have granted regulatory approval to sell the drug.

Synagis is designed to prevent a lower-respiratory-tract infection in premature babies. MedImmune continues to increase sales primarily by marketing it for use in premature babies in the United States and by persuading doctors and parents of the need to re-treat babies a year later.

Respiratory syncytial virus (RSV) often causes nothing more than a cold in healthy infants. But in "at-risk" infants, including premature babies, it results in more than 125,000 hospitalizations a year in the United States, MedImmune says.

RSV most often strikes in the winter, resulting in a sales spurt for Synagis from October through May.

Shares of MedImmune gained 25 cents to close at $32.03.

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