Biotech Values

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EU agency backs Nycomed's Daxas after U.S. rebuff

http://www.reuters.com/article/idUSLDE63M10W20100423

* European Medicines Agency recommends Daxas for COPD

* Decision follows vote against approval by U.S. panel

* Forest Laboratories has U.S. rights to Daxas

(Adds comment from Nycomed, details on drug)

By Ben Hirschler

LONDON, April 23 (Reuters) - Privately owned Swiss drugmaker Nycomed [NYCMD.UL], which is aiming for an initial public offering (IPO) at some stage, won a consolation prize on Friday as European regulators backed a key lung drug after a recent rebuff in the United States.

The European Medicines Agency said it was recommending approval of Daxas as a maintenance treatment for severe chronic obstructive pulmonary disease (COPD) in conjunction with a bronchodilator.

Nycomed said the once-a-day tablet medicine was expected to be launched in the first European countries later this year, once it was formally given marketing authorisation by the European Commission.

Earlier this month, a U.S. Food and Drug Administration panel voted 10-5 not to recommend Daxas, dealing a blow to Nycomed and its partner Forest Laboratories <FRX.N>, which has U.S. marketing rights to the drug.

The fate of Daxas is key to its developer Nycomed, which has said in the past it wants to launch an IPO but has never given an exact timetable for listing its shares in Switzerland.

Daxas is also pivotal for Forest, which is trying to build its portfolio ahead of the 2012 patent expiration for its huge-selling antidepressant Lexapro.

Industry analysts have estimated peak annual sales could hit $500 million or more -- but the drug's setback in the U.S. has placed its commercial prospects under a cloud.

Daxas, known generically as roflumilast, works by inhibiting an enzyme called PDE4 that is linked to inflammation. Nausea, diarrhoea and weight loss are known side effects of the PDE4 inhibitors.

It could win a niche in the multibillion-dollar worldwide COPD market, alongside rivals such as GlaxoSmithKline's <GSK.L> Advair and Spiriva, marketed by Pfizer <PFE.N> and Boehringer Ingelheim, analysts believe.