Wednesday, August 10, 2005

No New PML Cases in Tysabri

http://tinyurl.com/ax2pd
By TSC Staff
8/9/2005 8:10 AM EDT

Two star-crossed biotech companies took a step toward redemption Tuesday.

Biogen (BIIB:Nasdaq - commentary - research) and Elan (ELN:NYSE - commentary - research) announced that a safety review of patients taking their drug Tysabri for multiple sclerosis found no new cases of the rare brain disease progressive multifocal leukoencephalopathy.

Tysabri was pulled from the market in February after being linked to the disease, which is known by the abbreviation PML. The companies subsequently confirmed three cases of PML, two of which were fatal (and one of which occurred in a patient taking the drug for something other than multiple sclerosis: Crohn's disease.)

The withdrawal, which decimated both companies' stocks, prompted a broad safety review both of patients taking Tysabri in clinical trials and those who had used it under doctor's prescriptions. On Tuesday, Biogen and Elan said about 1,800 patients in clinical trials participated in a safety evaluation, with no new cases of PML discovered.

"Given the high unmet medical need in MS and the therapeutic benefit we have seen with Tysabri, we are encouraged by these safety findings," the companies said. "We look forward to working with regulatory authorities to determine the path forward for Tysabri."

In premarket Instinet trading, shares of Biogen were up 6.8% to $41.03, while Elan rose 19% to $9.52.

According to the companies, an ongoing safety evaluation of Tysabri in Crohn's disease and rheumatoid arthritis should be completed by the end of the summer.

Biogen and Elan said they're "taking preliminary steps to restart clinical trials in MS."

http://www.thestreet.com/_googlen/stocks/biotech/10237179.html?cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA

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