BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Wednesday, 7 August 1997.
AmBisome, the company's proprietary, liposomal antifungal product, now is approved by regulatory authorities for sale in 29 countries throughout the world. Promotion and distribution in South Korea will be handled by the Yuhan Corporation.
"This is our first approval in an Eastern Asian country, and with a population of approximately 45 million, South Korea represents a significant market for AmBisome," said Patrick J. Mahaffy, president and CEO of NeXstar Pharmaceuticals. "We are particularly pleased to receive another first line approval, which provides further evidence of the strong clinical data supporting the use of AmBisome."
In the United States, AmBisome is currently under review by the U.S. Food and Drug Administration (FDA) for use as an empirical therapy for patients with a low white blood cell count who have developed a presumed fungal infection, also known as Fever of Unknown Origin (FUO). NeXstar Pharmaceuticals and its U.S. marketing partner Fujisawa USA also are seeking indications for severe, systemic fungal infections and visceral leishmaniasis, and as a secondary treatment for fungal infections refractory (that do not respond) to amphotericin B treatment.
While considering the full New Drug Application (NDA) package, the FDA sought the advice of its Antiviral Drugs Advisory Committee regarding the empiric therapy of patients with FUO, and on July 16, 1997, the Committee unanimously recommended that the FDA approve AmBisome for this indication, based on the results of a pivotal Phase III study. NeXstar Pharmaceuticals has filed for approval for FUO in certain of its European markets.
NeXstar Pharmaceuticals Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and commercial globalization of products to treat life-threatening diseases, including cancer, immunological, hematological and infectious diseases. Current products on the market include AmBisome (outside the U.S.) and DaunoXome (U.S. and International). The company is based in Boulder, Colo. with research, development and manufacturing facilities in San Dimas, Calif., Lakewood, Colo., and Boulder, Colo., and its marketing subsidiaries are located worldwide. (http://www.nexstar.com/Press_Releases/PR97.htm)
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CONTACT: NeXstar Pharmaceuticals Inc., Boulder Michael E. Hart, VP, CFO, 303/546-7613 Katy Doherty, Manager, Media Relations, 303/546-7889
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