Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday, 4 August 1997.
The Russian Ministry of Health approved AmBisome, the company's liposomal antifungal drug, as a first line treatment in adults and infants for the treatment of severe systemic fungal infections, including fever of unknown origin (FUO), candidiasis, cryptococcosis, cryptococcal meningitis, aspergillosis , and histoplasmosis. AmBisome now is approved by regulatory authorities for sale in 28 countries throughout the world.
"This approval for AmBisome represents another important market for us and we plan to launch shortly," said Patrick J. Mahaffy, president and CEO of NeXstar Pharmaceuticals. "Also, it reflects our growing success in receiving approval to market AmBisome as a primary therapy rather than solely as a second line therapy. Over the next few quarters, we hope to achieve similar first line approvals in our existing markets as well as in additional markets worldwide."
DaunoXome, the company's liposomal anticancer agent, was approved for the treatment of Kaposi's sarcoma (KS), including KS in AIDS patients with low lymphocyte counts. DaunoXome is approved by regulatory authorities for sale in 18 countries throughout the world.
In the United States, AmBisome is currently under review by the U.S Food and Drug Administration (FDA) for use as a primary therapy for patients with a low white blood cell count (febrile neutropenic) who have a presumed fungal infections, also known as FUO. Additionally, NeXstar Pharmaceuticals and its U.S. marketing partner Fujisawa USA are seeking therapeutic indications for severe, systemic fungal infections, prophyl axis (as a preventative measure) in liver transplant patients, and visceral leishmaniasis, and as a secondary treatment for fungal infections refractory (that do not respond) to amphotericin B treatment.
Of these indications, 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. 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. The Company has headquarters in Boulder, Colo.; research, development and manufacturing facilities in San Dimas, Calif.; Lakewood, Colo., and Bou lder; and marketing subsidiaries worldwide.
(http://www.nexstar.com/Press_Releases/PR97.htm).
CONTACT: Michael E. Hart, Vice President and Chief Financial Officer, 303-546-7613, or Katy Doherty, Manager of Media Relations, 303-546-7889, both of NeXstar Pharmaceuticals/
Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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