Elan CFO sees Tysabri rollout in EU, US beginning in 3Q

Last Update: 10:36 AM ET May 4, 2006

DUBLIN (MarketWatch) -- Elan Corp. PLC (ELN) Chief Financial Officer Shane Cooke confirmed Thursday that the marketing of its multiple sclerosis Tysabri in the E.U. and U.S. will begin in the third quarter of 2006, following the likely approval by both continents' drug regulation agencies.

The European Medicines Agency's advisory committee has recommended Tysabri only be used in the E.U. as a treatment for relapsing multiple sclerosis patients; the agency's decision is due sometime this summer.

And the U.S. Food & Drug Administration's advisory committee has advised that Tysabri be reintroduced as a monotherapy in the U.S., a first-line treatment for all MS sufferers; the FDA's decision is due by June 28.

Cooke said on a media conference call that Tysabri's E.U. rollout is expected to begin in Germany "some time in the third quarter" and that the U.S. rollout would take place "in a matter of weeks" following an FDA ruling in the company's favor.

"Germany is a pretty significant part of the European market," Cooke added. "In the next year or so, we'd expect to launch in most other (E.U.) countries."

Cooke went on: "It (Tysabri) will have lower penetration in the E.U. than the U.S., as Europeans don't see the existing therapies as being as effective in relation to their cost."

He said the E.U. has around 150,000 MS patients on a therapy, with an extra 50,000 patients who've quit existing therapies; the U.S. has 200,000 MS patients on a therapy, also with another 50,000 so-called "quitters."

However, he conceded that the process of labeling Tysabri in individual E.U. countries will take several months, compared to the near-simultaneous rollout that will be possible across the U.S.

Lars Ekman, Elan's president of research and development, said he believes the FDA will take on board the FDA advisory committee's majority ruling and approve Tysabri as a first-line therapy.

Elan and partner Biogen Idec Inc. (BIIB) suspended their would-be blockbuster drug in the U.S. on Feb. 28 last year after three patients on combination therapy - including Tysabri - contracted a rare neurological disease called PML.

At 1245 GMT Thursday, Elan was up 8 cents at EUR11.48 on the Irish Stock Exchange in a flat overall market.

Company Web site: http://www.elan.com

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