Source: Hong Kong Med J  |  Posted 6 years ago

DEERFIELD, IL -- May 13, 2005 -- Astellas Pharma US, Inc. announced today the launch and availability of their newest systemic anti-fungal agent Mycamine(TM) (micafungin sodium) for Injection to hospitals nationwide. The U.S. Food and Drug Administration approved Mycamine in March 2005 for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and the treatment of esophageal candidiasis. Mycamine is the first product to be launched by Astellas Pharma US, Inc., which was recently formed through the merger of Fujisawa Healthcare, Inc. and Yamanouchi Pharma America, Inc.

"The launch and availability of Mycamine, an important new therapeutic option for physicians managing difficult to treat fungal infections in immunocompromised patients, underscores Astellas' commitment to bringing innovative products to market," stated Kurt Lewis, senior vice president marketing and sales at Astellas Pharma US, Inc. "Mycamine is the first new product for recently formed Astellas Pharma US, Inc. and an important step in solidifying our presence in the anti-infective market."

Astellas Pharma US, Inc. recently signed a co-promotion agreement with Roche Pharmaceuticals. Under the agreement, Roche will augment Astellas Pharma US Inc.'s dedicated hospital sales force in the promotion of Mycamine throughout the United States.

About Mycamine
The approval of Mycamine was based on 32 global studies conducted in 2402 subjects 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.

Mycamine is a member of a new class of antifungal agents, the echinocandins. Mycamine inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida. Mycamine can be used concomitantly with a variety of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus.

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 nausea and 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.

SOURCE: Astellas Pharma US, Inc.