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Ireland’s Elan Trims Losses As MS Drug Sales Surge

By Pharmaceutical Processing | February 10, 2009

By SHAWN POGATCHNIK Associated Press Writer DUBLIN (AP) — Irish biotechnology company Elan Corp. said Tuesday its losses narrowed sharply in 2008 as sales surged, driven by its top drug, the multiple sclerosis treatment Tysabri. Elan said its 2008 net loss shrank to $71 million (euro55 million), 82 percent smaller than its loss of $405 million the previous year. Revenues rose 32 percent to $1 billion, driven by a 140 percent gain in worldwide sales of Tysabri, which accounted for $557.1 million on its own. The Dublin-based company said it expected 2009 to bring a double-digit growth in sales. Elan stopped short of forecasting its first return to operating profit since 2002 — the year that Elan came close to bankruptcy amid an accounting scandal and the failure of an experimental treatment for Alzheimer’s disease. An exceptional $236.6 million tax benefit in 2008 also distorted Elan’s year-on-year improvement. Analysts said a better guide to Elan’s performance came in its operating losses, which narrowed 40 percent to $109.3 million. Elan shares rose 1 cent to euro6.39 ($8.24) in morning trade on the Irish Stock Exchange. Tuesday’s earnings statement shed no light on Elan’s ongoing exploration of a possible sale of a 25 percent stake to a larger biotechnology company. On Jan. 13 Elan announced that it was considering a minority investment, strategic alliance, merger or sale. “Elan is committed to completing its review of potential alternatives as promptly as practicable,” the company said in a statement. Tysabri continued its strong rebound from a disastrous launch in 2005, when Elan and its U.S. partner, Biogen Idec Inc., quickly withdrew the drug from the U.S. market after it was linked to development of a rare, often fatal brain-swelling disease called PML. Elan reiterated Tuesday that five MS-afflicted customers of Tysabri had contracted PML since its relaunch in 2006 from a pool of 48,300 current or former users. Four of those cases were disclosed from August to December, and Biogen disclosed the fifth case Monday. Both companies have declined to specify whether any of those patients have died. American and European authorities cleared Tysabri for use in mid-2006 under more restricted circumstances. Since then Tysabri has gained increasing acceptance as the most effective treatment for multiple sclerosis, an incurable disease of the central nervous system that can cause sudden, partial paralysis. Elan’s share of U.S. sales of Tysabri grew 94 percent to $421 million. Sales in the rest of the world, chiefly Europe and Australia — where regulators and markets had moved more slowly because of the PML risk — surged nearly tenfold to $135.5 million. Elan and Cambridge, Massachusetts-based Biogen share production costs and sales income from Tysabri, which Biogen manufactures. As part of their pact, Elan said Tuesday it has made compensation payments to Biogen of $75 million in July 2008 and $50 million in January to maintain its 50 percent stake in Tysabri’s performance. Elan said 37,100 MS sufferers were being treated with Tysabri worldwide at the end of 2008, up 77 percent from 12 months earlier. Analysts say Elan’s future growth depends on developing an approved treatment for the brain-destroying disease Alzheimer’s. The company is pursuing several Alzheimer’s-related clinical trials, some in cooperation with U.S. drug giant Wyeth. Elan said its 2008 spending on research and development, chiefly in Alzheimer’s treatment research and trials, rose 26 percent to $328.7 million. The company said its total debts, bills and other liabilities rose 4.8 percent to $1.87 billion. Chief Financial Officer Shane Cooke said Elan would make reducing its debts a priority in 2009.

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