Amgen, the world's largest biotech company, is under fire again on news that it did not reveal to investors negative results from a cancer study involving its top-selling drug, even though the results were issued in December.The study of 500 patients with head and neck cancer, conducted in Denmark, was testing whether the anemia drug Aranesp could be used as a treatment for the disease. The idea was that the medicine would cause more oxygen to get to tumors, making the radiation therapy that is the standard of care for head and neck cancer more potent.
Instead, the patients who received Aranesp were 10% more likely to see their tumors grow, according to an interim report of the trial available on the Web.
Amgen has known about the negative outcome since December, when it received a letter from the Danish researchers running the clinical trial, called DAHANCA 10. The Thousand Oaks, Calif., biotech told regulators within 24 hours but did not issue a press release.
It also did not mention the study results during the company's first quarter earnings call last month.
On a conference call Friday afternoon, Amgen chief executive Kevin Sharer (pic) said that, in retrospect, the result should have been disclosed, although Amgen still has not seen the raw data from the study.
"They were fairly contrite about not telling us about it," says Geoffrey Porges, an analyst at Sanford C. Bernstein. "I don't think that's going to give investors a lot of comfort about their disclosure policies."
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