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NeXstar Pharmaceuticals' AmBisome Receives First Line Approval BOULDER, Colo. -- Jan. 23, 1996 -- NeXstar Pharmaceuticals, Inc., (NASDAQ:NXTR) announced today that the AustralianTherapeutic Goods Administration (TGA) has approved AmBisome as a primary therapy for systemic fungal infections caused by candida, aspergillus and cryptococcus, and for visceral leishmaniasis. In addition, the TGA has approved AmBisome as a prophylaxis for liver transplantation patients at risk for developing fungal infection. These actions mark the first time any regulatory body has approved AmBisome as a primary therapy for the treatment of life-threatening fungal infections or as a prophylaxis to prevent fungal infections in susceptible individuals. The TGA landmark decision was based on data generated by a wide range of Company-supported clinical trials. This same data, along with other data gathered since the Australian submission occurred, will serve as the basis for further regulatory submissions worldwide seeking first line approvals for AmBisome. "This most recent approval for AmBisome not only represents an important milestone in the clinical development of this life-saving drug, but is a reflection of the quality of data that we have gathered demonstrating AmBisome's superior efficacy and safety compared to conventional amphotericin B therapy," said Michael E. Ross, NeXstar's Vice President of Medical and Regulatory Affairs. "We have already proven our ability to maintain our dominant market share in the face of competitive introductions, and part of our strategy to continue doing so is to develop AmBisome in broader indications," said Patrick J. Mahaffy, NeXstar's President and Chief Executive Officer. "In fact, during the coming months we plan to use the wealth of high-quality clinical data that we have generated from numerous comparative clinical trials to carry out this strategy." NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases. The Company currently markets two drugs, AmBisome and DaunoXome. The company has headquarters in Boulder, Colorado; research, development and manufacturing facilities in San Dimas, California, Antwerp, Belgium, Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide. CONTACT: NeXstar Pharmaceuticals, Inc., Boulder | Joseph Alper, 303/546-7717< E-mail this page to a friend or colleague! To print, use this version