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1/31/2003

Amevive Licensed for Treatment of Chronic Plaque Psoriasis

Kate Traynor

Biogen Inc. of Cambridge, Mass., announced today that the Food and Drug Administration approved the licensing of alefacept, or Amevive, a biological product used for the treatment of psoriasis.

According to the product's labeling, alefacept is used in the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Alefacept is a recombinant fusion protein whose components interfere with the activation of the T cells believed to play a role in the development of chronic plaque psoriasis.

The labeling states that the product should be used only under the guidance and supervision of a physician. Doses are to be administered intravenously or intramuscularly once a week for 12 weeks. The recommended intravenous dose is 7.5 mg, and the intramuscular dose is 15 mg. Amevive is supplied in an intravenous formulation, containing 7.5 mg of alefacept per 0.5 mL of solution after reconstitution, and an intramuscular formulation, containing 15 mg of alefacept per 0.5 mL. Additional courses of therapy can be given only if 12 weeks have elapsed since the last dose was administered.

Because Amevive can reduce the number of CD4+ T cells in the circulation, patients' levels should be monitored weekly and therapy withheld if the cell count falls below 250 per microliter. Therapy with alefacept should stop if the CD4+ T-cell count remains low for a month.

Biogen has arranged with Amerisource Bergen Corp. to supply the product to physician offices as early as Monday. Delivery of the product to patients is also available through an agreement with Priority Healthcare Corp., a specialty pharmacy distributor.

In an investors' conference call held this morning, Doug Abel, vice president of the Skin Diseases Unit at Biogen, said that the two distribution channels were created to take into account the methods used by insurers to cover the cost of the medication.

Specifically, Abel said, the product should be delivered directly to patients if reimbursement occurs through a pharmacy benefit. When the product is covered as a medical benefit, Abel said supplies would be sent to the treating physician.