Biotech Values

[genisi]

found some answers here:

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070525:MTFH25660_2...

UPDATE 3-Amgen to appeal as EU experts reject Vectibix drug
Fri May 25, 2007 10:13 AM ET

(Adds Amgen stock move)

By Ben Hirschler

LONDON, May 25 (Reuters) - The European Medicines Agency dealt a blow to Amgen Inc. <AMGN.O> on Friday by recommending its drug Vectibix should not be approved for treating colorectal cancer.

The world's biggest biotech company said it would appeal against the decision, which would block one of its key new medicines getting to market in the European Union.

Its stock slipped nearly 1 percent in early Nasdaq trade.

Amgen, based in Thousand Oaks, California, said it was confident available data showed Vectibix improved progression-free survival in patients with later-stage disease for whom other chemotherapy treatments had failed.

But experts from the London-based agency criticised the design of the main clinical study used in Amgen's submission and said they were concerned there was not sufficient evidence to show the drug's benefits.

"In the first few weeks of the study, many of the patients originally receiving best supportive care alone started to receive Vectibix after their disease had got worse, making it difficult to compare the effects of Vectibix and best supportive care alone," the agency said.

"In addition, Vectibix only had a very small effect in increasing the time until the disease got worse or the patient died, in comparison with best supportive care. Studies also showed that patients receiving Vectibix had increases in side effects."

Vectibix, which was approved last year in the United States, has been seen as a key medicine in the development pipeline of U.S.-based Amgen.

But it suffered a setback in March when Amgen discontinued a trial of the medicine, in combination with other drugs, after it was shown to reduce chances of survival for colon cancer patients, leading analysts to slash sales forecasts.

Vectibix, which is also facing tough competition from ImClone Systems Inc.'s <IMCL.O> Erbitux, had sales of $59 million in the three months to March, its second full quarter on the market.

In Europe, Erbitux is marketed by Germany's Merck KGaA <MRCG.DE>, whose shares advanced 1 percent to 99.24 euros by 1345 GMT following news of the setback for the rival product.

Amgen has had a torrid time recently, with its shares hit hard since January by concerns over its best-selling anaemia drug Aranesp.