DEERFIELD, Ill. and BASEL, Switzerland, March 31 /PRNewswire/ -- Fujisawa Healthcare, Inc. and Roche Pharmaceuticals today announced a partnership for the U.S. co-promotion of MYCAMINE(TM) (micafungin sodium) injection, Fujisawa's newly approved product for the treatment of patients with esophageal candidiasis and for the propylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. MYCAMINE, an antifungal in the echinocandin class, was approved by the US FDA on March 16, 2005. It is the first echinocandin approved for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
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 ritonivir and the transplant medications cyclosporine and tacrolimus. Under the announced agreement, Roche will utilize its highly experienced hospital sales force to augment Fujisawa's promotion of MYCAMINE throughout the United States. Fujisawa will book sales and compensation to Roche will be based on product sales.
"Fujisawa is proud to welcome Roche among our impressive list of business partners," stated William E. Fitzsimmons, Pharm.D., Senior Vice President, Business Development. "Our collaboration with Roche for the co-promotion of MYCAMINE will allow us to reach further into the competitive hospital setting to bring this new therapeutic option to a greater number of physicians and the patients they treat."
"This agreement leverages our established leadership position in anti- infectives and our world-class sales force in the hospital market," said George Abercrombie, President and CEO of Hoffmann-La Roche Inc., the company's U.S. prescription pharmaceuticals division. "That is why MYCAMINE is a perfect fit for Roche, and offers an important new treatment option for patients in need."
The approval of MYCAMINE was based on 32 global studies conducted in 2402 patients 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, which inhibit cell-wall synthesis. The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat or prevent 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.
About Fujisawa Healthcare, Inc.
Fujisawa Healthcare, Inc., headquartered in Deerfield, Ill., 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 actively developing its international operations in North America, Europe, and Asia. Fujisawa Healthcare, Inc. established its presence in the anti-fungal market with the launch of AmBisome(R) (liposomal amphotericin B) in 1997. Additional information on Fujisawa Healthcare, Inc. and its products can be found on the Internet at http://www.fujisawa.com/. On April 1, 2005 Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. will merge to form Astellas Pharma Inc. More information regarding Astellas Pharma Inc. can be found at http://www.astellas.com/.
About Roche as a Partner
Roche is a valued partner to over 75 companies worldwide. In the past two years, Roche has led the pharmaceutical industry in the number of new clinical compound deals signed. In 2004, Roche brought nine potential products into the company and strengthened its positions in oncology, virology and primary care. Roche's alliance strategy is to create a partnering culture where innovation flourishes and the partnership grows.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com/ and U.S.: http://www.roche.us/).
Fujisawa Healthcare, Inc.; Roche Pharmaceuticals