Amgen Inc. and its European marketing partner, Switzerland-basedHoffmann-La Roche, received approval from the European Union'sregulatory agency to market Neupogen for enhancing numbers ofperipheral blood progenitor cells in cancer patients receiving highdoses of chemotherapy.
The approval by the European Committee on Proprietary MedicinalProducts represents the fourth market indication for Neupogen. Thedrug, a granulocyte colony-stimulating factor, is designed to boostproduction of white blood cells.
Amgen, of Thousand Oaks, Calif., and Hoffmann-La Roche alreadymarket Neupogen in Europe in association with chemotherapy andbone marrow transplants and for treatment of severe chronicneutropenia. In the U.S., Amgen, alone, markets Neupogen for thosesame three indications.
David Kaye, Amgen's spokesman, said the company expects to file anew drug application with the FDA this year to expand the label toinclude peripheral blood progenitor cells. He noted Amgen also isanticipating results from Phase III trials of Neupogen as a treatmentfor infectious pneumonia.
Worldwide Neupogen sales were $719 million in 1993 and areexpected to increase about 10 percent for 1994. Kaye said 1994 salesfigures won't be tallied until Feb. 1.
Amgen's stock (NASDAQ:AMGN) closed Friday at $57.94, up$1.44. _ Charles Craig
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