Amgen Inc. and F. Hoffmann-La Roche Ltd. on Monday receivedmarketing approval in the United Kingdom for Neupogen,Amgen's granulocyte colony stimulating factor (G-CSF) to treatfebrile neutropenia.
The United Kingdom was the second European nation toapprove G-CSF since the European Community's Commission forProprietary Medicinal Products in February approved use ofthe drug in EC countries. Sweden approved G-CSF last Friday.
The Food and Drug Administration granted U.S. marketingapproval in February.
G-CSF is a protein that regulates the production and release of aclass of white blood cells called neutrophils. Febrileneutropenia, characterized by fever and a low white blood cellcount, is a common side effect of chemotherapy.
Amgen's European approval puts it at least a year ahead ofrival Immunex Corp. of Seattle.
Immunex's partner, Behringwerke AG of Marburg, Germany, ismanaging the European clinical development program forImmunex's Leukine granulocyte macrophage colonystimulating factor (GM-CSF). Behringwerke expects to file forapproval in Europe sometime this year for bone marrowtransplant indications, said Immunex spokesman Jason Rubin.U.S. marketing approved for Leukine was granted earlier thismonth.
Amgen, of Thousand Oaks, Calif., and Roche will jointly marketNeupogen in EC countries under the terms of an agreementsigned in September 1988. Amgen has U.S. marketing rights,while Roche, based in Basel, Switzerland, will sell Neupogen inthe rest of the world.
Amgen common stock (NASDAQ:AMGN) Monday closed down$1.63 at $120.63. Immunex stock (NASDAQ:IMNX) closed at$52.38, up 63 cents.
-- Karen Bernstein BioWorld Staff
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