Health Canada Approves Antifungal Agent Amphotericin B

March 22, 2000

New York (MedscapeWire) Mar 22 — Fujisawa Healthcare, Inc. and Gilead Sciences, Inc, have announced that Fujisawa Canada, Inc, a subsidiary of Fujisawa, has received marketing approval from Health Canada for the antifungal 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 antifungal 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 US 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 with amphotericin B lipid complex (Abelcet, The Liposome Company) in the treatment of the indicated fungal infections.

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 with amphotericin B lipid complex in the treatment of empirical infections.