Amgen Angst.Amgen Inc. investors, who have witnessed the biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. giant's share price fall 12 percent in the past month, were probably shaking their heads last week after the latest snafu. The respected industry newsletter Cancer Letter reported Feb. 16 on negative results from a Danish study on the anemia treatment Aranesp in head-and-neck cancer patients. The findings follow earlier studies indicating that aggressive use of Aranesp may increase the chances of a rare secondary tumor tumor: see neoplasm. growth. Meanwhile, the aggressive use of its predecessor drug Epogen has been associated with a rare anemia-related blood disorder Noun 1. blood disorder - a disease or disorder of the blood blood disease cytopenia - a deficiency of some cellular element of the blood acidemia - a blood disorder characterized by an increased concentration of hydrogen ions in the blood (which falls . Thousand Oaks-based Amgen apparently knew about these Danish results in December, but executives didn't mention the study during the company's Jan. 25 earnings call, when at length they discussed Aranesp safety concerns and the potential competition from copy-cat drugs. In a quickly arranged conference call the day the Cancer Letter story came out, Amgen Chief Executive Kevin Sharer acknowledged the company erred by not bringing up the matter sooner. Another Aranesp aggravation Any circumstances surrounding the commission of a crime that increase its seriousness or add to its injurious consequences. Such circumstances are not essential elements of the crime but go above and beyond them. arose last Thursday when it was announced that a potentially lucrative, but as yet unapproved un·ap·proved adj. Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. new use of Aranesp had been taken off a list compiled by medical researchers that is often used by insurers to determine whether to reimburse for drug's use. Aranesp is approved to treat chemotherapy-induced anemia and anemia related to kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , but not yet for anemia in cancer that's not associated with chemotherapy. JP Morgan analyst Geoffrey Meacham told Reuters that the loss of the listing could put at risk about $400 million to $500 million of future world-wide Aranesp sales, around 12 percent of the drug's 2006 sales. Amgen spokesman David Polk points out that the recent negative safety studies concern experimental uses for Aranesp for which the company has not yet sought FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval. The company also has seen no signs that carriers are denying claims. "When you look at Aranesp in its on-label application, it has a terrific safety profile," he said. Staff reporter Deborah Crowe can be reached at (323) 549-5255, ext. 232, or at dcrowe@labusinessjournal.com. |
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