Fujisawa Healthcare, Inc. and Roche Announce Co-promotion of MYCAMINE(TM)
Related News: Stem Cell ResearchDEERFIELD, 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."
About MYCAMINE
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.
Posted on March 31, 2005 06:04 PM