News Briefs
* Wyeth-Ayerst Pharmaceuticals of Madison, N.J., announced on December 11 that Rapamune (sirolimus) had received a unanimous positive opinion for marketing authorization from the Committee for Proprietary Medicinal Products, the scientific advisory body of the European Medicines Evaluation Agency. According to Wyeth-Ayerst, the CPMP recommended that Rapamune be indicated "for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant…[and] be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if cyclosporine can be progressively discontinued." Rapamune will now move to the final steps in the process for marketing authorization by the European Commission. See www.wyeth-ayerst.com/news/story.asp?id=419
* Orphan Medical of Minneapolis announced on December 13 that it had reached an agreement with Kirin Brewery Company giving the company exclusive rights to market and distribute Busulfex (busulfan) Injection in Japan, the People's Republic of China, South Korea, and Taiwan. Kirin must first conduct clinical trials with Busulfex, and regulatory approvals in the four countries are not expected for another three or four years. A conditioning regimen for bone marrow and stem cell transplants, Busulfex was approved in the United States and Canada last year and was approved in Israel in March 2000. See www.orphan.com.
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