For Kevin Sharer, there’s just one disappointment and setback after another.

This time, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion about marketing Amgen’s Vectibix for treating patients with metastatic colorectal cancer who have failed chemotherapy. Amgen plans to appeal.

Vectibix, which was approved last year by the FDA, has been seen as a key medicine for the beleaguered biotech. But Amgen had to discontinue a trial of the medicine, which was being tested in combination with other drugs, after it was shown to reduce chances of survival for colon cancer patients, leading Wall Street to slash forecasts.

Of course, Amgen has other troubles. Congress and the New York attorney general are investigating marketing practices for Aranesp and Epogen; and the Securities and Exchange Commission is probing Amgen’s failure to disclose negative trial data, and an FDA panel says still more serious warnings are required for the drugs. The company is also delaying construction of a new $1 billion plant in Ireland.

Meanwhile, Jim Reddoch of Friedman Billings Ramsey wrote in an investor note this morning that NDC monthly prescription data for April showed that daily Aranesp sales declined 16%, with totat units declining 13% over March. This is a steeper decline than we had expected and is indicative of a continuing negative trend for Aranesp.

But Sharer, the bulldog ceo, maintains a crisis doesn’t exist.

[tags]Amgen, Vectibix[/tags]