BOSTON, July 24 /PRNewswire/ -- Roche, a leader in organ transplant medicine, announced today the launch of a new Web site designed to be a valuable resource for transplant professionals, patients and organizations.
This comprehensive Web site, www.RocheTransplant.com , offers a single location to access a variety of valuable patient management tools, as well as the latest information about Roche transplant-related research, current and future treatment options and community services. The site will be unveiled at the 2006 World Transplant Congress, a joint meeting of the American Society of Transplant Surgeons, American Society of Transplantation and The Transplantation Society.
“Roche is passionate about conducting cutting-edge clinical research, as well as supporting the transplant community -- including clinicians, researchers and organ transplant recipients. This Web site will provide comprehensive information and support for healthcare professionals and their patients, highlighting in one place the key Roche offerings for the transplant community,” said Tim Waugh, Vice President, Transplant, at Roche.
The Web site offers information about ongoing research in transplant immunology and virology, and houses information on Roche Diagnostics, Roche Molecular Diagnostics and the Roche Biomarker Program. Transplant professionals can access various resources, including interactive calculators for MELD, PELD and CrCL. In addition, www.RocheTransplant.com contains patient education materials and information on community initiatives such as the Roche organ donation awareness programs Linkages to Life and Get Game - Give Life(TM), and The Bear Hugs Program(TM) which provides support for pediatric transplant recipients and their families coping with the special challenges of organ transplantation in children.
Industry-Leading Science
Roche has been a company of firsts in transplant medicine, and for more than a decade has marketed and researched innovative products to improve the success of transplantation, with a focus on improving long-term outcomes with immunosuppressant protocols and minimizing the risk of viral infections. Roche continues to look for new and innovative ways to advance transplantation care. The current transplant treatment portfolio includes CellCept(R) (mycophenolate mofetil), the number one prescribed branded immunosuppressant in the U.S. for kidney, heart and liver transplants; Valcyte(R) (valganciclovir), the leading antiviral used to prevent cytomegalovirus (CMV) infection in high-risk patients with kidney, heart and kidney-pancreas transplants and to treat CMV retinitis in people with AIDS; and Zenapax(R) (daclizumab), used for prophylaxis of acute organ rejection in patients receiving renal transplants. Additionally, the company has a strong pipeline in transplant medicine, including the investigational compounds R3421 (BCX-4208), daclizumab as maintenance therapy and CRB-15. Roche also has opt-in rights for the Isotechnika compound ISA247.
In addition to pharmaceutical therapies, Roche is also a world leader in diagnostics with a uniquely broad product portfolio, focusing on areas where patients can benefit from individualized therapies based on adequate monitoring and treatment, such as transplantation. Roche focuses on cutting-edge technology through the Roche Molecular Diagnostics division, which designs, develops and markets diagnostic and blood screening tests based on Nobel-prize winning polymerase chain reaction (PCR) technology. Another cutting-edge program is the Roche Biomarker Program, which encompasses a very broad scientific, technological and market vision to drive the discovery and validation of biomarkers in support of the therapy areas being pursued by the Pharmaceuticals and Diagnostics divisions.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people’s health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America, ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power) and one of AARP’s Top Companies for Older Workers. For additional information about Roche’s U.S. pharmaceutical business, visit our Web sites: www.rocheusa.com or www.roche.us .
Facts About CellCept, Valcyte and Zenapax
CellCept is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants.
There are no adequate and well-controlled studies in pregnant women. As CellCept has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy.
Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information).
Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leucopenia (patients should be monitored for neutropenia; dosing should be interrupted or the dose reduced if neutropenia develops), thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.
Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
Warning: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance
therapy should have complete information requisite for the follow-up of the patient.
Valcyte, the oral pro-drug of Cytovene (ganciclovir), is the most widely prescribed anti-CMV medication in the United States. Valcyte is indicated for the prevention of CMV disease in kidney, kidney-pancreas and heart transplant patients at high risk. Valcyte is not approved for use in liver transplantation. The efficacy and safety of Valcyte in other solid organ transplants, such as lung transplant, have not been established.
The clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis. Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/microliter, the platelet count is less than 25,000/microliter or the hemoglobin is less than 8 g/dL. Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with a frequency of greater than or equal to 5% included diarrhea, tremors, fever, nausea, headache, vomiting, insomnia and allograft rejection.
In liver transplant patients, there was a significantly higher incidence of tissue-invasive CMV disease in the Valcyte-treated group compared with the oral ganciclovir group (see CLINICAL TRIALS in the complete product information).
Zenapax is a humanized monoclonal antibody that blocks interleukin-2 (IL-2) receptors and acts as an immunosuppressant. It is used just before and/or at the time of kidney transplantation in combination with cyclosporine and corticosteroids to prevent early rejection. The recommended dose of Zenapax is 1.0 mg/kg. Based on clinical trials, the standard course of Zenapax therapy is five doses. Zenapax received U.S. Food and Drug Administration (FDA) approval in December 1997.
The most frequently reported adverse events associated with Zenapax were constipation, nausea, diarrhea and vomiting. Cellulitis and wound infections occurred more frequently in patients treated with Zenapax versus placebo. Severe hypersensitivity reactions following Zenapax administration have been reported rarely.
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Zenapax. The physician responsible for Zenapax administration should have complete information requisite for the follow-up of the patient.
For full prescribing information on CellCept, Zenapax and Valcyte, please visit: www.rocheusa.com/products/transplantation.html .
Roche
CONTACT: Maureen Byrne of Roche, +1-973-562-2203, cell: +1-973-800-5097,maureen.byrne@roche.com; Adam Pawluk of Ketchum, +1-646-935-4135, cell:+1-917-847-8488, adam.pawluk@ketchum.com, for Roche
