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| |  FDA Approves Antifungal Mycamine (Micafungin Sodium) DEERFIELD, IL -- March 17, 2005 -- Fujisawa Healthcare, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the use of micafungin sodium, the antifungal product for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and the treatment of esophageal candidiasis. The newly approved agent will be marketed in the United States under the name Mycamine™ (micafungin sodium for injection). "This is an important milestone in Fujisawa's commitment to develop novel compounds that help patients with serious diseases," said Hideo Fukumoto, Chairman and Chief Executive Officer, Fujisawa Healthcare, Inc. "Mycamine will allow us to expand our depth in the anti-fungal market and offer patients another treatment option to fight or prevent a life-threatening candida infection." Currently, Fujisawa markets the anti-fungal AmBisome® (a liposomal formulation of amphotericin B) in the United States. According to a recent study, invasive candidiasis kills 10 - 40 percent of infected immunocompromised patients. "Immuno-compromised patients whose white blood cell contents are lowered are highly susceptible to candida infections," said Ira D. Lawrence, M.D., Senior Vice President, Research and Development. "Mycamine can be an effective preventative therapy for immunocompromised patients who undergo bone marrow or stem cell transplants and are highly susceptible to candida fungal infections." Clinical Trials The approval is based on 32 clinical studies conducted in the United States, Canada, Japan, South America, Europe and Africa. The clinical development program included data from 2402 subjects. Subjects in the Mycamine studies included a broad range of individuals who had a confirmed, or were at risk for, candida fungal infections, including patients with hematologic malignancies, bone marrow transplant recipients, and HIV-positive patients. In 3 large, well controlled, clinical trials, Mycamine has been shown to have an overall safety profile, and discontinuation rate, similar to that of fluconazole. About Mycamine Mycamine is a member of a new class of antifungal agents, the echinocandins, which inhibit cell-wall synthesis. The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat the infection. Mycamine is contraindicated in patients with hypersensitivity to any component of the product. Patients receiving Mycamine have reported isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock), significant hemolysis and hemolytic anemia. The most common side effects experienced in the clinical trials included changes in liver and renal function. Possible histamine-mediated symptoms have been reported with Mycamine, including rash, pruritus, facial swelling, and vasodilatation. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at Mycamine doses of 50-150 mg/day.
AmBisome is a registered trademark of Gilead Sciences, Inc.
SOURCE: Fujisawa Healthcare, Inc.
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