Biogen Idec, Elan Rerelease Tysabri for U.S. Market 17 Months After Sales Halt

CAMBRIDGE, Mass. -- Biotech drug maker Biogen Idec Inc. and Ireland-based drug maker Elan Corp. said Monday its multiple sclerosis treatment Tysabri is now available in the U.S. 17 months after the companies pulled the drug from pharmacies.

In June, the Food and Drug Administration re-approved the drug with certain restrictions. Now, Tysabri must be prescribed by doctors participating in a special program called the Touch Prescribing Program. Elan runs the program through ICS, a drug distributing unit of AmerisourceBergen Specialty Group, and 12 specialty pharmacies.

Originally approved in November 2004, Tysabri was taken off the market three months later when three cases of a rare and often fatal brain inflammation occurred in multiple sclerosis patients taking the drug. Two of the patients died.

Multiple sclerosis is an incurable disease wherein the immune system attacks the insulation of the nerve fibers by mistake.

The annual wholesale cost of Tysabri per patient is about $28,400, a 20 percent premium to what some analysts had expected.

The companies also announced they launched the drug in Europe after receiving a recent approval from the European Commission.

Elan's American depositary shares rose 39 cents, or 2.9 percent, to $13.70 in premarket activity on the INET electronic exchange. Shares of Biogen closed Friday at $40.73 on the Nasdaq.