Heavy losses reported in 2005 by Drug maker Elan with hopes for Tysabri rebound

Elan Corp. PLC, which is awaiting a verdict from U.S. regulators on a key suspended drug, reported narrower net losses Tuesday and expressed hopes of a rebound this year. Ireland's leading drugmaker reported a fourth-quarter loss of US$58.3 million (48.2 million euros), substantially lower than the US$107.1 million loss for the same quarter in 2004. Revenues for the October-December period rose to US$140.4 million (116 million euros) from US$123.8 million a year earlier.

For the full year, Elan said its net loss came to US$383.6 million (317 million euros), slightly lower than 2004's loss of US$394.7 million. Revenues grew to US$490.3 million (405.2 million euros) from US$481.7 million in 2004.

Investors who had been advised to expect even steeper losses snapped up Elan shares on the Irish Stock Exchange in Dublin, sending the shares up 1.9 percent to 12.13 euros (US$14.68).

Analysts say Elan's fortunes depend heavily on whether the U.S. Food and Drug Administration permits the company's key drug in development, Tysabri, to return to the American market. Elan's top brass are publicly optimistic that will happen.

"We should know by the end of March how to relaunch the drug in the U.S. market," said Kelly Martin, Elan's president and chief executive. He forecast that European regulators also would permit Tysabri's sale in mid-2006.

Elan and its U.S. development partner, Biogen Idec Inc. of Cambridge, Massachusetts, withdrew Tysabri from sale in February 2005 over fears that the multiple sclerosis-fighting drug could be linked to a rare, usually fatal brain disease called PML.

At the time, Elan and Biogen Idec said two MS sufferers had contracted PML, one fatally, while a third Tysabri user who took the drug to treat Crohn's disease, an intestinal disorder, also had died of PML.

But both companies said a later survey of about 3,500 clinical-trial users of Tysabri had failed to detect any new PML cases, opening the way for a fast-tracked FDA review.

"We are well positioned to re-market Tysabri, and the progress we have made in improving our operating leverage will accelerate our return to profitability," said Shane Cooke, Elan's chief financial officer.

Martin said the company was committed "to delivering tangible results."

"For 2006, we will continue to focus on making measurable progress in our science, technology and commercial activities," he said. "Such focus, discipline and alignment will enable us to deliver benefits to patients, shareholders and our employees."

Elan's shares which, after Tysabri's withdrawal, plummeted from above US$26 (22 euros) to below US$3 (2.50 euros) have gained in recent months in expectation of an eventual return for Tysabri with new FDA-imposed warnings.

"There will be some restrictions for the drug," Martin said, "but it's very premature to say what those restrictions might be." He said Tysabri represented "an important part of the short-term success of Elan," while the company's ongoing effort to develop a treatment for Alzheimer's disease constituted the most important of several "long-term, big-growth business opportunities", reports the AP.

D.M.