Tuesday, October 18, 2005

Elan Says No New Nerve Disease Cases in Tysabri Study (Update1)

http://tinyurl.com/8qzrz

Oct. 17 (Bloomberg) -- Elan Corp. and Biogen Idec Inc. said that a safety study found no new confirmed cases of the rare nerve disease that caused multiple sclerosis drug Tysabri to be withdrawn on Feb. 28. Elan shares jumped as much as 10 percent.

Progressive multifocal leukoencephalopathy, or PML, was not found in any more patients with Crohn's disease and rheumatoid arthritis, Dublin-based Elan, Ireland's biggest drugmaker, said in a statement today. The safety study has been completed, and the data submitted to the European Medicines Agency, Elan said.

``The next significant step in the drug's return to market is the FDA's response to the request for a priority review of its license application, which should be known within the next 10 days,'' Goodbody analyst Ian Hunter wrote in a note, referring to the U.S. Food and Drug Administration. ``Acceptance would be a strong positive signal on the prospects for the drug's meaningful return to market.''

Elan and Cambridge, Massachusetts-based Biogen Idec pulled Tysabri from the market after three treated patients developed PML. A review of MS patients did not find additional cases of the rare disease. The companies asked the FDA for a priority review of Tysabri last month, which may result in a decision by April 2006, according to NCB analyst Orla Hartford.

Elan shares gained 55 cents, or 8.3 percent, to 7.17 euros as of 9:44 a.m. in Dublin, after rising as high as 7.30 euros.


To contact the reporter on this story:
Etain Lavelle in London at elavelle1@bloomberg.net.
Last Updated: October 17, 2005 04:50 EDT

http://www.bloomberg.com/apps/news?pid=10000102&sid=aaqVHCNOI3eE&refer=uk

0 Comments:

Post a Comment

<< Home