Amgen Inc. announced Tuesday that Neupogen has been approved inthe U.S. for use in bone marrow transplantation patients, an indicationfor which it already owns more than half the market in off-label usage.Neupogen (Filgrastim), recombinant human granulocyte colony-stimulating factor, is a version of a protein that stimulates production ofneutrophils. It already is approved in Japan and the European Union forbone marrow transplantation, but its major indication by far is as anadjunct to cancer chemotherapy, where it holds 90 percent of the Neupogen sales were $719 million in 1993, $545 million ofwhich came in the U.S. Sales in the first quarter of 1994 for Neupogenin the U.S. were $132 million.Kevin Wilson, a managing director of New York-based S.G. Warburg& Co. Inc., told BioWorld that the approval was "a minor positive." Hesaid his forecast of $760 million in Neupogen sales for 1994 isunchanged by the new approval, which he said will have a negligibleimpact.David Kaye, manager of production communications for Amgen, toldBioWorld that there are about 8,000 bone marrow transplantations peryear in the U.S. He said the fact that Amgen now can promote the drug,and that the market is growing, should help fuel sales in that indication.Amgen, of Thousand Oaks, Calif., has a new drug application pendingwith the FDA for Neupogen to treat severe chronic neutropenia, a rarecondition in which the body is unable to produce sufficient quantitiesof neutrophils.Previously, Immunex Corp.'s Leukine was the only product approvedfor bone marrow transplantation. The granulocyte macrophage colony-stimulating factor has been available from the Seattle company since1991.Amgen (NASDAQ: AMGN) stock was up 38 cents Tuesday, closing at$45.25. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.