Amgen Inc., the largest seller of biologic drugs, announced on Aug. 15th that it was cutting more than 2,200 jobs in a restructuring unprecedented in its quarter of a century history that mirrors the rise of the biopharmaceutical industry.
The company said the cutbacks were the result of restrictions on its anemia biologic Aranesp, which as a result of safety concerns and new government restrictions, saw sales fall 19 percent in the second quarter to $578 million from $713 million a year earlier.
Kevin Sharer, chief executive officer of Amgen, said the trigger for the restructuring was a very "patient unfriendly" decision by Medicare on July 30th restricting use of Aranesp and other anemia biologics in the treatment of anemia in cancer chemotherapy patients.
Studies reported earlier this year pointed to potential negative consequences from use of Aranesp and other biologics to overly boost hemoglobin in cancer patients, including blood clots and heart attacks and increased growth of tumors.
An FDA advisory panel in May voted to add more restrictions to the Aranesp label, and while doctors and patient groups have been fighting with Medicare over its efforts to curtail Aranesp, the government may not retreat further on its restrictions on conditions under which it will reimburse for the drug.
The new rules issued so far also apply only to coverage of the biologics for treatment of anemia in cancer patients -- not patients with kidney failure, who are covered by separate Medicare rules. Regulations for these patients are expected to be revised following a hearing this fall by an FDA advisory panel.
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