Study of 1,500 patients shows no new brain disorder cases from MS drug; withdrawn earlier in 2005.
October 17, 2005: 9:48 AM EDT

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DUBLIN (Reuters) - Irish pharmaceutical maker Elan and U.S. partner Biogen Idec said on Monday a new safety study of their drug Tysabri showed no new cases of a potentially fatal brain disorder, pushing up Elan shares.

Elan (Research) shares climbed over four percent in pre-market electronic trading on the Inet exchange.

The latest safety study of Tysabri in patients with Crohn's disease and rheumatoid arthritis (RA) showed no new confirmed cases of progressive multifocal leukoencephalopathy (PML), Elan and Biogen Idec (Research) said in a statement.

The results, which came from an evaluation of 1,500 Crohn's and RA patients, mirrored the results of a similar safety study of Tysabri in patients with multiple sclerosis (MS).

Elan shares jumped 8.7 percent to 7.2 euros at the open of the Dublin market but had eased slightly to 7.1 euros by 0330 ET.

Elan and Biogen are seeking to get Tysabri back on the market after its withdrawal in February following the death of an MS patient from PML. Two further cases were later confirmed, one of which also proved to be fatal.

Elan and Biogen said they had also submitted data to the European Medicines Agency on Tysabri for the treatment of MS, similar to the data sent to the U.S. Food and Drug Administration (FDA) last month.

Ian Hunter, an analyst at Goodbody Stockbrokers, said the market would now be looking for the FDA's response to the companies' request for a priority review of their license application.

"Acceptance (by the FDA) would be a strong positive signal on the prospects for the drug's meaningful return to the market," he said in a note to investors.

Industry analysts hailed Tysabri as a potential blockbuster when it was launched in November 2004 because clinical data suggested it was more effective than existing MS treatments.

Elan, which has clawed its way back from near-collapse three years ago, has been pinning its future on the drug, formerly known as Antegren.

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http://money.cnn.com/2005/10/17/news/international/elan.reut/index.htm