Vestar Inc. announced Tuesday that it has received approval tomarket its liposomal formulation of amphotericin B inGermany.
The product, AmBisome, is for treating severe systemic fungalinfections, which can cause mortality rates as high as 70percent in cancer patients who have received chemotherapy, inrecipients of organ and bone marrow transplants, and in AIDSpatients. Amphotericin B is commonly used to treat theseinfections; however, it is very toxic at doses that are onlyslightly effective. In contrast, Vestar's (NASDAQ:VSTR)liposomal version of the drug appears to be well-tolerated.
Michael Hart, chief financial officer of the San Dimas, Calif.,company, said that AmBisome has already been approved inIreland, the United Kingdom and Sweden. "Having the U.K. andGermany under our belt can only help us (get productapproval) in the other countries," Hart said. "Overall, AmBisomeis sold in 21 countries," he told BioWorld, with annualized salesover $25 million. Hart said that AmBisome has not beenapproved for sale in the U.S., where Fujisawa USA owns therights.
Liposomal Technology Inc. of Menlo Park, Calif., and TheLiposome Company Inc. of Princeton, N.J., are developingsimilar products, but "neither has been approved in Europe,"Hart said.
Vestar has been showing a profit since the third quarter of1991, Hart told BioWorld. The company has more than $60million in cash and about 16.5 million fully diluted sharesoutstanding.
(c) 1997 American Health Consultants. All rights reserved.