No new brain-infection cases with Biogen drug (TYSABRI)

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http://www.reuters.com/article/rbssHealthcareNews/idUSN0846669820080108CORRECTED-UPDATE 1-No new brain-infection cases with Biogen drug

Tue Jan 8, 2008 8:22am EST

(Corrects Oct. 11 story to show date of Tysabri's return to

market was July 2006, not last July)

(Updates with details, analyst comment)

BOSTON, Oct 11 (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and

partner Elan Corp (ELN.I: Quote, Profile, Research) said on Thursday that as of the end

of September there have been no new reported cases of a

potentially deadly brain infection in patients taking their

multiple sclerosis drug Tysabri.

Cambridge, Massachusetts-based Biogen and Ireland-based

Elan released the data ahead of a presentation at the Congress

of the European Committee for Treatment and Research in

Multiple Sclerosis in Prague.

The companies said about 17,000 patients are taking Tysabri

in the United States and Europe. Of those, 1,000 are in

clinical trials.

Tysabri was taken off the market in 2005 after being linked

with three cases of progressive multifocal leukoencephalopathy,

or PML. The U.S. Food and Drug Administration allowed the drug

back in July 2006 because it is effective and patients asked

for it to be returned.

Tysabri is available in the United States through a

safety-monitoring program known as TOUCH. All prescribers,

infusion sites and patients are required to enroll in the

program, which is designed to monitor patients for any signs or

symptoms of PML.

The longer time goes by with no new cases of PML, the more

comfortable doctors are in prescribing it.

"The Tysabri safety and utilization update provided today

gives us comfort with our Street-high 2007 Tysabri worldwide

end user sales forecast of $357 million."

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