UPDATE 2-EU agency backs Nycomed’s Daxas after U.S. rebuff

* 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 (BestGrowthStock) – 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.

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(Editing by Will Waterman and Sharon Lindores)

UPDATE 2-EU agency backs Nycomed’s Daxas after U.S. rebuff