Immunex Corp. announced Wednesday that the EuropeanCommunity's Committee for Proprietary Medicinal Products hasrecommended approval of its white blood cell booster,Sargramostim.
Immunex (NASDAQ:IMNX) of Seattle already markets thisyeast-derived granulocyte macrophage colony stimulatingfactor (GM-CSF) in the U.S. under the trade name Leukine forpatients underdoing autologous bone marrow transplantationand to improve survival in patients whose bone marrowtransplants have failed. Immunex recently merged withAmerican Cyanamid Inc.
The European application, which covers both these indications,was filed by the company's development partner,Behringwerke AG, which will pay Immunex royalties andmarket the product in Europe.
The recommended approval involves France, Germany, Italy,Luxembourg, Belgium, the Netherlands, Denmark, Greece,Ireland, Portugal, Spain and the United Kingdom.
Leukine is the first product Immunex manufactured andmarketed. The product received FDA approval in March 1991.Hoechst-Roussel Pharmaceuticals Inc. of Somerville, N.J., a U.S.subsidiary of Behringwerke AG of Germany, sells the drug asProkine in the U.S. under a co-development and co-marketingagreement.
Sargramostim is designed to stimulate white blood cellproduction in patients whose bone marrow has been depletedin chemotherapy. Although patients receive bone marrowtransplants, many recipients experience significant delaysbefore the new marrow begins producing white blood cells, andare susceptible during this period to life-threatening infections.Up to 20 percent of bone marrow recipients may experiencegraft failure.
Schering Plough Corp. and Sandoz Pharmaceuticals Corp.received a recommendation for approval of a similar drug,Leucomax, last September. Amgen Inc.'s granulocyte colonystimulating factor (G-CSF), Neupogen, is also marketed inEurope through an agreement with Roche Holding AG.
Immunex's stock closed Wedensday at $41.25 a share, up 50cents.
-- Nancy Garcia Associate Editor
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