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Elan: on Track to File Applications for MS Drug

http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=5134341&section=news

Thu 13 May, 2004
Kevin Smith
Reuters

Irish drug maker Elan Corp Plc narrowed its loss in the first quarter after cutting costs and selling off assets and confirmed on Thursday it was on track to file applications for its flagship drug Antegren.

The net loss narrowed to $67.1 million, or $0.17 per share, from a pro forma $140.2 million, or $0.40 per share, in the first quarter of 2003, while revenues from retained products rose seven percent to $75.4 million, the company said.

The results were slightly ahead of some analysts' forecasts, pushing the share price up more than seven percent to 17.8 euros by 9:35 a.m. EDT on a moderately positive Dublin bourse.

Former high-flier Elan, which has clawed its way back from a collapse in its stock in 2002, said it was on schedule to file Antegren for treatment of multiple sclerosis (MS) and Prialt for chronic pain with U.S. and European regulators in the current quarter.

"We're still on the timeline of being able to file Antegren for MS by mid-year in the U.S. and a few months later in Europe, and we're currently in discussions with both the European and U.S. agencies for Antegren for Crohns disease," Elan Chief Executive Kelly Martin told Reuters in an interview.

"We anticipate Antegren for MS and Prialt would be in the marketplace in the first quarter of 2005, and Antegren for Crohns after that."

Elan, which has made a dramatic comeback since 2002 when it was hit by concerns about liquidity and a probe by U.S. authorities into its accounting practices, is pinning its hopes on the success of Antegren.

Elan's share price, which plunged to less than two euros in 2002 from a 2001 peak of nearly 74 euros, was catapulted to two-year highs in March by news Elan was ready to seek regulatory approval for Antegren as a treatment for MS more than 12 months ahead of schedule.

If approved by the U.S. Food and Drug Administration (FDA), Antegren -- which Elan is developing with Biogen Idec --would be a strong contender in a growing market underpinned by more than 700,000 MS sufferers in Europe and the United States.

"Antegren will be priced as a premium product to the current market, so the opportunity from a revenue point of view...for Antegren is north of $6 billion," Martin said.

Asked about how much Antegren would cost to bring to market, Martin noted partner Biogen had flagged a figure of around $60 million in a conference call last week.

"It's not finalized, but you can assume that roughly in line with where Biogen is -- we're going to be somewhere around that same neighborhood."

Martin said he believed the U.S. Securities and Exchange Commission had completed its inquiry into Elan's accounting practices -- a factor that has overhung the company's share price -- and that talks between the two would begin soon.

"Our goal would be to have resolved (these) issues by the third quarter of this year," he said.

Elan's total first-quarter revenues fell to $159 million from $224.7 million due to asset disposals, while total operating expenses were reduced by 29 percent to $212.6 million.
 

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