(BW) FDA Antiviral Drug Committee Finds AmBisome Safe and Effective for Treatment of FUO

(BW) FDA Antiviral Drug Committee Finds AmBisome Safe and Effective for Treatment of FUO

BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Wednesday, 16 July 1997.

SILVER SPRING, Md.--(BW HealthWire)--July 16, 1997--NeXstar Pharmaceuticals, Inc. (NASDAQ:NXTR) and Fujisawa USA, Inc. announced that the U.S. Food and Drug Administration (FDA) Antiviral Drug Products Advisory Committee voted unanimously today that AmBisome(R) is safe and effective as empirical therapy for presumed fungal infections in febrile neutropenic (low white blood cell count) adult and pediatric patients.

Empirical therapy is treatment based upon the clinical symptoms of a patient, rather than the results of culture tests. The vote of the Advisory Committee was based primarily upon its review of the results, presented by Fujisawa USA, of the pivotal Phase III multi-center study which compared AmBisome to the traditional formulation of amphotericin B. The vote of the Advisory Committee, while not binding upon the FDA, represents a significant step forward in the joint effort by NeXstar and Fujisawa to obtain FDA approval of AmBisome as a treatment for fever of unknown origin (FUO), which particularly affects those patients with compromised immune systems such as recipients of bone marrow or solid organ transplants, AIDS patients , and patients undergoing chemotherapy.

"We and our partners at Fujisawa USA are extremely pleased with the vote of the Advisory Committee," said Patrick J. Mahaffy, president and CEO of NeXstar Pharmaceuticals, Inc. "If ultimately approved by the FDA for this indication, we believe that AmBisome will be a significant addition to the U.S. marketplace and will build upon its already successful use in markets outside the U.S."

Noboru Maeda, president and CEO of Fujisawa USA, stated that: "If approved, AmBisome will be an important addition to those Fujisawa USA pharmaceutical products already available to the transplant and anti-in fective communities."

NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and globalization of products to treat life-threatening diseases, including cancer and infectious diseases. Two products currently on the market are AmBisome (outside the U.S., in Europe and several other countries) and DaunoXome(R). Based in Boulder, Colo., NeXstar Pharmaceuticals' research, development and manufacturing facilities are located in San Dimas, Calif. and Lakewood, Colo.; marketing subsidiaries are located worldwide.

Fujisawa USA, Inc., headquartered in Deerfield, Ill., is a manufacturer of proprietary and multi-source pharmaceutical products and a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical, founded in 1894, is a leading pharmaceutical manufacturer and is actively developing operations not only in Japan but on a global scale, particularly in North America, Europe and Asia.

CONTACT: NeXstar Pharmaceuticals, Inc. Katy Doherty, 303/546-7889 Pager 800-999-6710 ID No. 993-2860 or Michael E. Hart, 303/546-7613; or Fujisawa USA, Inc. Mark J. Wanda, 847/317-1256

Keywords: IMMUNE SYSTEMS; AIDS PATIENTS

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