Press Releases

Astellas Pharma announces the availability of Mycamine® in Canada

MARKHAM, ON, October 17, 2007 – Astellas Pharma Canada, Inc., is pleased to announce that Mycamine® (micafungin sodium for injection) is now commercially available in Canada. Mycamine was approved by Health Canada in May 2007, for the treatment of esophageal candidiasis and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. This is the first echinocandin to be approved for the prophylaxis of Candida infections.

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. Based on the results of 32 international clinical studies, Mycamine has demonstrated effectiveness and safety in the treatment of Candida fungal infections in patients with hematologic malignancies, bone marrow transplant recipients or those who are HIV positive. Mycamine can be used concomitantly with a variety of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus.

"Fungal infections can be a serious complication for patients with a compromised immune system," says Barbara Reynolds, Director of Marketing, Astellas Pharma Canada, Inc. "We are pleased to provide health professionals with an effective clinical option to manage these infections and help improve patient quality of life."

Mycamine is now approved in eight countries for the treatment of esophageal candidiasis and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Mycamine is also approved and indicated for the treatment of candidemia and invasive candidiasis in Japan, Jordan, USA, China, Taiwan, Korea, Syria and Canada.

About Mycamine®
The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat or prevent infections. 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 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.¹

About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc. is highly focused on customers and their needs and is committed to making a difference in the treatment of infectious diseases. Astellas Pharma Canada, Inc., is dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas Pharma Canada is one of the Astellas Group of companies in North America and an affiliate of Astellas Pharma Inc., located in Tokyo. The organization is committed to becoming a global pharmaceutical leader by combining outstanding R&D and marketing capabilities. Additional corporate information is available at www.astellas.com/ca.

® Mycamine is a registered trade-mark of Astellas Pharma Inc.

For further information, please contact: Communications MECA Lindsay Peterson 1-866-337-3362 x229

References:

1. Mycamine Product Monograph, Astellas Pharma Canada, Inc. April 9, 2007.