BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Tuesday August 12, 1997 - 12:02 PM EDT
Fujisawa USA, Inc. and NeXstar Pharmaceuticals, Inc. (NASDAQ:NXTR) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance to market AmBisome(R) (amphotericin B) liposome for injection for use as empirical therapy for presumed fungal infections in patients with depressed immune function and fever of unknown origin.
AmBisome is the first true liposomal formulation of amphotericin B. Amphotericin B, introduced in the 1960's, is an antifungal agent which has long been considered the standard of care. AmBisome is the first and only amphotericin B product to be indicated for empirical therapy for presumed fungal infections in febrile, neutropenic patients.
AmBisome also received marketing clearance from the FDA for the treatment of patients with confirmed infections caused by various fungal species (Aspergillus, Candida and Cryptococcus) who are refractory to or intolerant of conventional amphotericin B therapy. In addition, AmBisome is indicated for the treatment of visceral leishmaniasis (a parasitic infection).
Nine clinical studies to evaluate the safety and efficacy of AmBisome were conducted, including a multicenter, double-blind trial that compared AmBisome with conventional amphotericin B in empirical therapy. In the double-blind trial, approximately 700 adult and pediatric patients with neutropenia and persistent fever of unknown origin were randomized to receive either conventional amphotericin B or AmBisome. Therapeutic success -- measured by a combination of factors including, among others, resolution of fever, absence of emergent fungal infection, and patient survival for at least seven days after therapy -- was equivalent between the two groups.
"AmBisome represents a significant addition to the clinician's arsenal for treating life-threatening fungal infections," said Noboru Maeda, president and CEO of Fujisawa USA, Inc. "As expected of a liposomal agent, the drug is safer and more tolerable than conventional amphotericin B."
"This is a great day for NeXstar and we look forward to the anticipated launch of this product by the end of the third quarter," said Patrick J. Mahaffy, president and CEO of NeXstar Pharmaceuticals. "For the first time, patients with presumed fungal infections can receive the potent activity associated with traditional amphotericin B, with a significant reduction in toxicity. We are proud to work with Fujisawa in bringing this product to patients and the physicians who serve them."
Patients treated with AmBisome had a lower incidence of chills (48% for AmBisome vs 76% for amphotericin B), elevated blood urea nitrogen (21% vs 31%), hypokalemia (deficiency of potassium in the blood - 43% vs 51%), and vomiting (32% vs 44%). Patients treated with amphotericin B had a lower incidence of diarrhea (27% for amphotericin B vs 30% for AmBisome) and nausea (39% vs 40%). Anaphylaxis has been reported with products containing amphotericin B, including AmBisome. Overall there was a lower incidence of adverse events associated with the use AmBisome as compared to amphotericin B. As anticipated, the liposomal AmBisome was less likely than conventional amphotericin B to cause kidney damage.
Patients at risk for systemic fungal infections include those with compromised immune systems, such as patients receiving cancer treatment, HIV-infected individuals, and bone marrow transplant patients. Patients afflicted with systemic fungal infections typically exhibit low levels of infection-fighting white blood cells and fever that does not resolve with antibiotic treatment.
"The improved safety in AmBisome is a welcome therapeutic advance in the empirical treatment of systemic fungal infections," said John Hiemenz, M.D. of the Walt Disney Memorial Cancer Institute in Orlando, Florida. "Conventional amphotericin B has always been a double-edged sword -- effective but toxic. This rigorous, double-blinded randomized study of seven hundred patients comparing AmBisome to conventional amphotericin B showed clearly that AmBisome is as effective but safer than amphotericin B."
While generally considered the standard treatment for systemic fungal infections, the usefulness of conventional amphotericin B has been limited by its potential to cause damage to the kidneys. While still having some potential to cause impairment in kidney function (elevated creatinine levels of 22% for AmBisome vs 42% for amphotericin B), AmBisome is able to deliver much higher dosages of amphotericin B while reducing the amount of kidney toxicity.
Fujisawa licenses the AmBisome marketing and distribution rights in the United States and Canada from NeXstar Pharmaceuticals, Inc. NeXstar will co-promote AmBisome in the United States and will also be responsible for manufacturing the product. AmBisome is currently approved and marketed by NeXstar in 29 other countries.
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 its operations not only in Japan but on a global scale, particularly in North America, Europe and Asia. Additional information on Fujisawa USA, Inc. can be found at www.fujisawausa.com ;
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. Based in Boulder, Colo., NeXstar Pharmaceuticals' additional research, development and manufacturing facilities are located in San Dimas, Calif., and Lakewood, Colo.; marketing subsidiaries are located worldwide. (http://www.nexstar.com/press_releases/pr97.htm) .
Contact:
NeXstar Pharmaceuticals Michael E. Hart, 303/546-7613 Katy Doherty, 303/546-7889 or Fujisawa USA, Inc. Mark J. Wanda, 847/317-1256
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