Europe's Committee for Proprietary Medicinal Products (CPMP)has recommended for approval Granocyte, the recombinantgranulocyte-colony stimulating factor (G-CSF) developed byChugai Pharmaceutical Co. The product will be marketed inEurope by Chugai-Rhone-Poulenc, the Japanese company's jointventure with Rhone-Poulenc Rorer (NYSE:RPR) of Collegeville,Pa.
The CPMP actually made its recommendation June 15; threedays later Sweden was the first European Community countryto formally approve Granocyte for marketing, explained BobPearson, director of public relations for RPR.
Chugai of Tokyo developed the drug through fundamental in-house studies and produces it in genetically engineered Chinesehamster oocytes. Chugai launched the drug in Japan asNeutrogin in late 1991.
Chugai-Rhone-Poulenc claims that Granocyte is the only"human identical glycosylated recombinant human G-CSF whichhas been granted a positive opinion (by the CPMP) for use inreducing the duration of severe neutropenia and associatedcomplications in cancer patients undergoing toxicchemotherapy and bone marrow transplantation."
But Amgen Inc.'s (NASDAQ:AMGN) recombinant human G-CSF,Neupogen, was recommended for approval by the CPMP forboth indications in May 1992, said Sarah Crampton, director ofinvestor relations at the Thousand Oaks, Calif., company.
There are, however, differences between the two products,explained Rhone-Poulenc's Pearson. He said Chugai's Granocyteis a glyco-sialated protein (Neupogen is not) and its amino acidsequence is human-identical (Neupogen's differs by one aminoacid).
Nonetheless, Amgen's Neupogen is now being sold by 10 of the12 European Community countries, while Chugai-Rhone-Poulenc's G-CSF probably won't be available in most Europeancountries until the end of this year or the beginning of 1994,Pearson told BioWorld.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.