Baxter Healthcare Corp.'s Biotech Group received Europeanregulatory approval for its Isolex 300 Magnetic Cell Separator lastweek, permitting the company to market its stem cell purificationsystem in all countries of the Europe Union.
Jeanne Pierson, vice president of marketing for Isolex, said thesystem, which is used to capture and purify CD34 cells in bonemarrow and peripheral blood stem cell transplants, already is sold infive European countries: Spain, Germany, France, Italy and Norway.
She said the system, which is marketed by the immunotherapydivision of Baxter's Biotech Group in Irvine, Calif., is in Phase I/IItrials in the U.S. in conjunction with autologous bone marrow andperipheral blood stem cell transplants for the treatment of breastcancer and lymphoma. Pierson added that the company expects tosubmit its premarket approval application (PMA) with the FDA in1996.
Baxter's major competitor in the stem cell purification field isCellPro Inc., of Bothell, Wash. Earlier this month, the FDA decidednot to approve CellPro's PMA for its Ceprate SC stem cellconcentration system, which was tested in Phase III trials withautologous bone marrow transplants used to treat breast cancerpatients.
CellPro has requested a meeting with the FDA to discuss the issuesraised by the agency. In the meantime, the company launchedanother Phase III study of the Ceprate system in autologousperipheral blood stem cell transplants for patients with multiplemyeloma.
CellPro's system is on the market in France and sold on a limitedbasis in 13 other European countries. The company expects to haveEuropean Union regulatory approval this year. Ceprate already hasbeen approved in Canada.
In addition to competing for sales, Baxter and CellPro are involvedin a patent dispute related to their cell purification systems. _Charles Craig
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