Replies to post #76179 on Biotech Values

[DewDiligence]

NVO’s Victoza (a/k/a liraglutide) Gets Thumbs Up from CHMP

[Victoza (awful brand name, IMO) is now as good as approved in the EU. The Europeans don’t seem to be unduly concerned about the drug’s safety, as the FDA advisory panel was (#msg-36777418).]

http://www.reuters.com/article/marketsNews/idINLN94201820090423

›Thu Apr 23, 2009 12:53pm EDT
By Ben Hirschler

* Positive view follows setback for drug in U.S.

* Launch expected in first European markets this summer

* Novo says no change to expectations for 2009 results

* Shares up 5 percent in U.S. trading

LONDON, April 23 (Reuters) - Novo Nordisk's key new diabetes drug Victoza received a significant boost on Thursday as European regulators recommended its approval, three weeks after U.S. experts cast doubt on its safety.

Shares in the Danish company were up 5 percent in U.S. trading after the news.

A European Medicines Agency expert panel issued a positive opinion supporting Victoza, also known as liraglutide, as a treatment for type 2 diabetes.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission in about two months.

Novo welcomed the news and said it expected to launch Victoza in a number of European markets during this summer. The group said the news did not change its expectations for the company's financial results for 2009.

The CHMP recommended Victoza, which is given by injection, for use in combination with older oral diabetes drugs.

Shares in Novo 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 will err on the side of caution, delaying -- and possibly blocking -- the drug's U.S. launch.

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 and Eli Lilly and Co's GLP-1 drug Byetta.‹