CORRECT: Novo Nordisk Expects FDA Feedback Liraglutide In Weeks

Danish pharmaceutical company Novo Nordisk A/S (NOVO-B.KO) said Wednesday that formal feedback from the U.S. Food and Drug Administration is expected within weeks for its diabetes treatment liraglutide regarding its commercial launch in the U.S.

The company said it expects to provide an update on the regulatory process for liraglutide on Feb. 2, 2010, when the company announces its full-year results, if formal feedback isn't received before then.

Analysts and investors see significant sales potential for liraglutide, marketed as Victoza. In contrast to conventional diabetes treatment with insulin, it doesn't risk pushing blood glucose dangerously low and also helps patients to lose weight.

However, the treatment faces upcoming competition from rival treatments in the same class of drugs, such as Byetta LAR, which is expected to reach the market during 2010. Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN) partnered with Alkermes Inc. (ALKS) to develop Byetta LAR.

An expert panel of the FDA in April came to a split decision on whether Victoza, a synthetic hormone that stimulates insulin production in the human body, was safe to be marketed after trials showed an increased incidence of tumors in rats and mice.

The U.S. regulator had been expected to give its final decision on Victoza before the end of 2009 after deferring feedback to the fourth quarter of the year.

European regulators earlier this year approved Victoza for launch in the European Union.

Shares in Novo Nordisk closed Wednesday at DKK332, valuing the company at 201.08 billion Danish kroner ($38.39 billion). The shares have risen more than 40% since April, in line with the wider Copenhagen market.

-By Ian Edmondson and Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3094; ian.edmondson@dowjones.com

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