Novo Nordisk says Victoza cleared for EU market

COPENHAGEN - Danish pharmaceuticals group Novo Nordisk's diabetes drug Victoza, a key driver for future sales, has won European Commission approval for marketing across the European Union, the company said on Friday.

The move had been expected, following a positive opinion from the European Medicines Agency on April23.

The European Commission has granted marketing authorisation for Victoza for the treatment of type 2 diabetes in adults, Novo Nordisk said in a statement, calling it an important milestone.

The company will launch Victoza -- which is the brand name for liraglutide -- in Britain, Germany and Denmark this summer and in other European markets in the second half of 2009 and throughout 2010, Novo Nordisk said.

The marketing approval in Europe does not change Novo Nordisk's expectations for the company's financial results for 2009, it added.

The company will give an updated outlook for its full-year 2009 financial results when it publishes first-half figures on August 6.

Novo Nordisk shares traded off 0.7 percent at 290 crowns by 0935 GMT in line with the Copenhagen bluechip index but underperformed a 0.5 percent rise in the DJ Stoxx European drugs sector index.

Victoza is the most important new drug in Novo Nordisk's pipeline. Its prospects, however, have been clouded because some experts have questioned its safety profile.

Shares in Novo Nordisk fell heavily on April 3 after a U.S. advisory panel handed down a split ruling on whether Victoza was safe enough to come to the market.

The U.S. Food and Drug Administration's outside experts voted 6-6 when asked if thyroid tumours found in tests of rats and mice should prevent sales of the drug. There was one abstention.

The final decision now rests with the FDA and investors fear the agency may err on the side of caution, delaying -- and possibly blocking -- the drug's launch in the all-important U.S. market.

Liraglutide belongs to the GLP-1 class of injectable drugs that stimulate insulin release when glucose levels become too high. If approved, it would provide competition for Amylin Pharmaceuticals Inc (AMLN.O) and Eli Lilly and Co's (LLY.N) GLP-1 drug Byetta. (Editing by Hans Peters)