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Serono Develops New Tracking and Distribution System for Anti-Wasting Drug Serostim
Serono Inc., the U.S.-based affiliate of the European biotechnology firm, has developed a new "secure distribution program" for its wasting treatment Serostim in light of concerns about the distribution of counterfeit versions of the drug, Reuters reports. Serostim is an injectable growth hormone that fights severe weight loss, a condition common among people with AIDS. In May, Serono notified regulatory and law enforcement officials about the circulation of counterfeit materials that had been packaged to appear as Serostim. The company has joined with the health information organization NDCHealth to develop the Serostim Secured Distribution program, which will track and monitor distribution of the drug from the manufacturer to the patient. Under the program, which was implemented this week, Serostim will be distributed only to a network of pharmacies that meet certain criteria, including mail order capacity, patient confidentiality, and reporting protocol. Although physicians will continue to prescribe Serostim as they have in the past, the company said that by the end of October, all prescriptions for the drug should be filled by a designated pharmacy. James Sapirstein, executive vice president of Serono, said that the program should also help authorities investigate a double-billing reimbursement scheme involving Serostim in which state agencies were billed twice for each package of the drug. "We're working very closely with the state agencies to shut this down and make sure this drug gets to the appropriate patients that need it," he said, adding that Serono was not involved in the fraud. A three-month supply of Serostim costs approximately $25,000 per patient, and Serono expects sales of the drug to total approximately $90 million to $100 million this year (Berkrot, Reuters, 10/2).
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