AMGEN NEUPOGEN PLA FILING ON TRACK FOR DECEMBER
AMGEN NEUPOGEN PLA FILING ON TRACK FOR DECEMBER submission to FDA, Amgen VP-Finance and Chief Financial Officer Lowell Sears told a Nov. 28 conference sponsored by the investment firm Robertson Stephens & Co. The Neupogen PLA will be filed for neutrophil stimulation in chemotherapy patients. Registration in European Community countries is targeted for early 1991, Sears said. The year-end deadline appears to represent a slight delay in Amgen's timetable for the drug; the company had originally targeted November as the month to submit its application for the granulocyte colony stimulating factor (G-CSF) product. Sears told reporters that the delay occurred when FDA asked the firm to submit the complete PLA in one piece and not on a rolling basis for the different clinical results. Amgen initially will submit data from eight clinical trials involving more than 700 chemotherapy patients and plans to expand on that patient database in the next year. There are an estimated 250,000 patients in the U.S. who could benefit from Neupogen treatment during chemotherapy, Sears said. Amgen currently is conducting G-CSF Phase III trials for chronic and febrile neutropenia. The drug is in Phase II trials for myeloplastic syndrome, a pre-leukemic condition that may affect 50,000 patients in the U.S., and in Phase II as a neutrophil stimulant in bone marrow transplant patients. Amgen also plans to seek a number of additional indications, including Neupogen's use as an adjuvant to AZT/gancyclovir treatment. Sears predicted that FDA approval could come before the end of next year. Amgen plans to add another 50 sales reps specifically for marketing Neupogen in preparation for the product launch. Amgen's Epogen (erythropoietin, EPO) sales force currently numbers about 50, with another 20 EPO salespersons to be added by the close of the current fiscal year in March, Sears told the conference. By Neupogen's launch date, Amgen hopes to have a total of 120 sales people for the two products. * EPO is currently available in 99% of the 2,000 dialysis centers in the U.S. following the drug's approval last June for treating anemia in patients with end-stage renal disease. Sears reported that EPO sales were approximately $ 30 mil. for the quarter ended Sept. 30. Despite the $ 30 mil. in Epogen revenues, Amgen decided to take a $ 4.8 mil. reserve for 10,000 units of EPO materials, held in inventory at Amgen's distributors and at the company itself, Sears noted. The initial flat $ 40 per administration reimbursement level "had a tendency to reduce or lower the initial dosages of the drug," used at dialysis centers, he said. Even though reimbursement was approved for June 1, retroactive from HCFA's June 22 reimbursement approval date, Amgen did not begin to receive reimbursement from most Medicare intermediaries until this month. As a result, Sears said, "this has created out in the dialysis marketplace among the purchasers of Epogen . . . somewhat of a working capital squeeze and for the last several months we have had fairly flat demand for Epogen at the Amgen sales level. That is now changing," he added. "As of the current time, over half the state intermediaries are now paying, and we expect to see the working capital crunch resolved and the extenuation of the increase in market penetration for EPO." Amgen expects that its arbitration proceedings with J&J's Ortho subsidiary over their licensing agreement for Epogen will be finished in January, Sears said. The company's patent suit with Genetics Institute over Marogen will be decided by Dec. 11
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