June 24, 2010 / 9:58 AM / 7 years ago

UPDATE 3-U.S. clears Merck lung drug as SkyePharma's stalls

* U.S. approves Merck combination asthma drug Dulera

* Dulera to be available in pharmacies by end of July

* SkyePharma pessimistic on U.S. prospects for Flutiform

* Merck shares little changed; SkyePharma slumps 18 percent

(Wraps SkyePharma news, adds latest share prices)

By Ben Hirschler

LONDON, June 24 (Reuters) - Merck & Co Inc’s (MRK.N) new two-in-one respiratory drug Dulera has been approved by the U.S. Food and Drug Administration, the U.S. company said on Thursday, confirming an earlier Reuters report.

But Britain’s SkyePharma Plc SKP.L said it was no longer hopeful of a U.S. green light for its rival combination treatment Flutiform.

Merck’s inhaled treatment has been cleared for use in patients 12 years of age and older, although it is not indicated for the relief of acute bronchospasm.

The fixed-dose combination of mometasone furoate and formoterol fumarate was developed by Schering-Plough and inherited by Merck when it acquired its smaller rival last year.

The new product combines the dual action of an inhaled corticosteroid and a long-acting beta agonist (LABA) to improve lung function in asthma sufferers.

That makes Dulera a rival for GlaxoSmithKline Plc’s (GSK.L) market-leading Advair and AstraZeneca Plc’s (AZN.L) Symbicort, both of which act in a similar way.

Recently the FDA has taken a critical look at LABA drugs, drawing up new warnings earlier this month for the inhaled treatments. [ID:nN02191721]

Some analysts said the issues over LABA safety may have delayed the FDA’s decision on Dulera, which had initially been expected by April.

In the end, however, the agency gave approval for the medicine and disclosed the move in an update on its website (link.reuters.com/ceh83m) before Merck issued a press release. [ID:nWLA6928]

Merck, whose shares were little changed in morning trade in New York, said it expected Dulera to be available in retail pharmacies across the United States by the end of July 2010. The drug is also being developed as a treatment for chronic obstructive pulmonary disease.

SkyePharma, meanwhile, saw its stock end 18 percent lower after announcing that the FDA had set tougher than expected demands for approving Flutiform, which could prove insurmountable.

“The company is working with its advisors to review all of the options available to it with a view to determining whether there is a viable way forward for Flutiform in the United States,” it said (Additional reporting by Paul Sandle; editing by David Cowell)

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