Genzyme Corp.'s Ceredase enzyme-replacement therapy has beenapproved in France, Germany and The Netherlands for treatment ofType I Gaucher's disease, the Cambridge, Mass., company saidThursday.The European Union's Committee for Proprietary Medicinal Productsrecommended approval of Ceredase in March. Genzyme said it expectsother European countries to approve the product in the next fewmonths. Ceredase was approved in the U.S. in 1991, and Cerezyme(recombinant glucocerebrosidase, or GCR), also for Gaucher's disease,was approved by the FDA in May.Because of the limited supply of Ceredase, which is derived fromhuman placentas, Genzyme plans to phase in Cerezyme, which hassimilar structure and clinical activity, after construction of a new plantis completed in Boston, which is expected in 1995, Steve Push,Genzyme's vice president for corporate communications, toldBioWorld.Gaucher's disease is a debilitating, sometimes fatal genetic disordercaused by a deficiency of the enzyme glucocerebrosidase. It ischaracterized by an enlarged liver or spleen, anemia, bleedingproblems, bone and joint pain, fatigue and orthopedic complications.Genzyme said there are about 2,000 Gaucher's patients who needtreatment in Europe, about the same number as in the U.S.Sales of Ceredase in 1993 were $125 million. Worldwide sales forCeredase and Cerezyme are projected to be $170 million for 1994,Kathleen Rinehart, Genzyme's public relations supervisor, toldBioWorld. About 300 people in Europe already were being treated withCeredase on a "named patient" basis."We're recruiting new patients (in Europe) but at a fairly low levelbecause of supply constraints," Push said. "At this point, we've beenable to meet all the demand."The average annual cost of Ceredase therapy is $140,000, but dropsafter patients get to a maintenance dose. Currently, Push said, it costsmore to produce Cerezyme, but that could change after completion ofthe new plant, where worldwide supply of the drug will be produced.Genzyme hasn't filed for European approval of Cerezyme.Ceredase was approved in Israel in 1992 and in Australia in February.Push said other companies are researching products to treat Gaucher'sdisease, but none have anything in the clinic.Genzyme (NASDAQ:GENZ) stock fell 38 cents per share Thursday,closing at $33.63. n
-- Jim Shrine
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