Thursday, May 25, 2006

Elan CEO sees 'headroom' to raise Tysabri's price

Last Update: 9:01 AM ET May 25, 2006

DUBLIN (MarketWatch) -- Elan Corp. PLC's (ELN) Chief Executive Kelly Martin said Thursday there is future "headroom" to raise the price of multiple sclerosis drug Tysabri after its anticipated return to the market in the U.S.


The U.S. Food & Drug Administration will make a final decision on Tysabri's re-entry by June 28, and most analysts see it back on the market in the U.S. in the third quarter of 2006.

"Clearly there's headroom and a business legitimacy for one to raise the price," Martin told a press briefing after the company's annual general meeting, adding the issue will be discussed with Elan's Tysabri partner Biogen Idec Inc. (BIIB).

Martin said: "We would need to see the final labeling and risk management dynamic before making any decisions on price." These details are currently being finalized by Elan and Biogen with the FDA, he added.

When the two companies temporarily suspended sales of the drug in the U.S. last year on safety concerns, patients were being charged $23,500 for 13 infusions a year, or 1 every 4 weeks.

Elan has repeatedly said it expects Tysabri to be reintroduced to the market and the MS drug could break even with around 20,000 patients, though the company expects to surpass this figure easily.

Martin said there are over 2.5 million MS sufferers worldwide and, although he wouldn't be drawn on specific figures, he said that Tysabri will play a "very substantial role" in the existing global market.

"We haven't predicted that (the market share) yet," he said, "but 70% of MS patients are declining clinically. When new products are introduced to an existing market, volatility increases and people tend to use the new technology."

Martin said it would be "premature" to make more accurate predictions, but added the company would be in a better position to make forecasts when Tysabri has been back on the U.S. market for at least two months.

He reiterated Tysabri's 68% reduction in MS relapses, compared with 30% for existing therapies and said this is the kind of data that will be highlighted in relation to labeling Tysabri in E.U. countries when the time comes.

The European Medicines Agency's advisory committee has recommended Tysabri be used in the E.U. only 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.

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

Company Web site: http://www.elan.com
-Contact: 201-938-5400 End of Story

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