Sure took them a long time to confirm this case.....
NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) reported that an eighth patient on its multiple sclerosis drug Tysabri, sold with Elan PLC (ELN), has developed a rare brain infection.
A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Prior to Friday, the company has reported that seven people had confirmed cases of PML, with one dying, since the relaunch. The most recent case was reported on May 22.
Shares of Biogen closed Friday down 8 cents at $51.38, while Elan rose 16 cents, or 2%, to $8.16.
The drug was allowed back on the market in 2006 because of its effectiveness in fighting the degenerative disease, and the PML incidence remains well below the long-projected risk of one in 1,000 patients developing the infection.
The patient with the latest confirmed PML case took 35 doses of the monthly medication, the most of any of the post-launch cases, and was located overseas. Only two of the eight cases since last July were located in the U.S.
Earlier this year, Biogen retreated from its long-held goal to reach 100,000 patients on Tysabri by the end of 2010. As of the end of March, about 40,000 patients were using Tysabri, up from 37,600 patients at the end of December.
Some believe that duration of therapy plays a role in Tysabri's risk. About 6,800 patients have used the drug for more than two years as of the end of March.
Biogen is posting a case update on the Internet every Friday at 4:30 p.m. EDT until July 24 - the third anniversary of the drug's relaunch - by which time it expects the risk/benefit profile of Tysabri to be clearer.
Tysabri had 2008 sales of $813 million, but its longer-term sales trajectory, which is key to Biogen's future growth, will depend on the true incidence of PML, which is still coming into focus. |
