March 20, 2000
Canada Approves Antifungal Agent Ambisome®
Deerfield, IL and Foster City, CA, March 20, 2000 -- March 20, 2000
Fujisawa Healthcare, Inc. (Fujisawa) and Gilead Sciences, Inc. (NASDAQ:GILD) today announced that Fujisawa Canada, Inc., a subsidiary of Fujisawa, received marketing approval from Health Canada for the anti-fungal agent AmBisome® (amphotericin B) liposome for injection. AmBisome will be marketed in Canada for the treatment of systemic or disseminated infections due to Candida, Aspergillus, or Cryptococcus in patients who are refractory to or intolerant of conventional amphotericin B therapy, or have renal impairment.
“AmBisome, our first anti-fungal product, is an exciting addition to our expanding Canadian portfolio in the transplantation and cardiovascular therapeutic areas,” said Yoshiyasu Ninomiya, general manager of Fujisawa Canada, Inc. “AmBisome represents another step in Fujisawa’s global strategic plan to be a leader in important niche markets.”
Fujisawa Canada will market AmBisome exclusively throughout Canada. Gilead will manufacture AmBisome at its San Dimas, California facility and receive royalty payments.
In August 1997 the U.S. Food and Drug Administration (FDA) approved AmBisome for a broader range of treatment. In addition to the indication approved in Canada, AmBisome is marketed in the United States for use as empirical therapy for presumed fungal infections in febrile, neutropenic patients as well as the treatment of visceral leishmaniasis. Additionally, in early February 2000, the FDA approved a label expansion for AmBisome that includes data showing AmBisome to have a superior safety profile compared to Abelcet® (amphotericin B lipid complex) in the treatment of the indicated fungal infections. Abelcet is manufactured by The Liposome Company.
Fujisawa Canada plans to file a supplemental new drug submission to Health Canada that seeks approval of AmBisome for use as empirical therapy for presumed fungal infections in febrile, neutropenic patients and first-line therapy for Cryptococcal infections. In addition, Fujisawa Canada seeks a label expansion by providing Health Canada with comparative data demonstrating the superior safety profile of AmBisome compared to Abelcet in the treatment of empirical infections.
About Fujisawa and Gilead
Fujisawa Canada, Inc., headquartered in Markham, Ontario is a subsidiary of Fujisawa Healthcare, Inc., headquartered in Deerfield, IL. Fujisawa Healthcare, Inc. develops, manufactures, and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe, and Asia. Additional information on Fujisawa Healthcare, Inc. and its products can be found on the Internet at www.fujisawa.com.
Gilead Sciences, headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in the United States, Europe and Australia.
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