Recombinant granulocyte colony stimulating factor (G-CSF) wasapproved by the European Community's pharmaceuticalregulatory agency, clearing the way for its approval inindividual EC countries, Amgen Inc. said Friday.
Amgen, of Thousand Oaks, Calif., said that its G-CSF, tradenamed Neupogen, met requirements in the EC for treating lowwhite blood cell counts in patients undergoing chemotherapy.The ruling was from the EC's Committee for ProprietaryMedicinal Products (CPMP). Amgen said its European marketingpartner, F. Hoffmann-La Roche Ltd. of Basel, Switzerland, willapply for approval in every EC country.
European sales of Neupogen could reach $92 million by 1992,according to Robert Kupor, a biotechnology analyst with Kidder,Peabody & Co. in New York.
In the United States, Neupogen is awaiting review by the Foodand Drug Administration after an FDA advisory committee lastDecember recommended its approval for preventing infectionsafter chemotherapy for those cancers that do not arise frombone marrow.
Amgen retained marketing rights for Neupogen in the UnitedStates, Canada and Australia. F. Hoffmann-La Roche hasmarketing rights in the rest of the world, except Japan, Taiwanand Korea, where Japan's Kirin Brewery has rights.
Amgen's stock (NASDAQ:AMGN) closed Friday at $84.75 ashare, up $1.75. -- Carol Ezzell
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