News Release

Long-term treatment with CellCept® reduces the risk of cancer In kidney transplant patients

Data reinforces CellCept's safety and efficacy profile

Peer-Reviewed Publication

Ketchum UK

3rd June 2003, Basel, Switzerland – New data from the largest-ever* three year study of over 13,500 people with kidney transplants show a reduced risk of developing any malignancy in patients treated with CellCept (mycophenolate mofetil - MMF), compared to those receiving other immunosuppressant treatment regimens.

Current thinking that all potent immunosuppressants increase the risk of malignancy has been challenged by these data. Physicians now have the evidence that CellCept, a potent immunosuppressant, can be used for the long term without increasing the risk of malignancies. Further analysis revealed that people receiving CellCept were also significantly less likely to develop lymphoma/PTLD (post transplant lymphoproliferative disease).

People undergoing kidney transplant surgery who receive conventional immunosuppressive treatment are 20-60 times more likely to develop malignant lymphoma when compared to the general population2 and the incidence and time to onset of cancer is thought to be related to the immunosuppressive regimen.3

Dr. Richard Robson, Director, Christchurch Clinical Studies Trust, New Zealand presented these new and unique results at the fourth joint American Transplant Congress (ATC), Washington, DC, USA.

Dr. Richard Robson, said: "These data challenge current assumptions about the link between lymphoma and long-term potent immunosuppressive therapy. Results today indicate that the mode of action of the specific immunosuppressive drug may be more important than we had previously thought regarding the risk of developing cancer. These data have important implications for clinical treatment choice and future patient survival." He continued: "Furthermore the prospective data confirm the patient and graft survival benefit of CellCept endorsing previous registry analysis."1

* prospective observational cohort study

Roche in Transplantation

Roche is strongly committed to improving the long-term outcomes of transplantation and enhancing the quality of life of transplant recipients. Roche has developed three innovative therapies that improve graft and post-transplant health: CellCept is the cornerstone of low toxicity immunosuppressant therapies. CellCept is the largest selling branded immunosuppressive in North America, offers both physicians and patients the possibility of an effective long term immunosuppressive regimen with low toxicity, Zenapax prevents the acute rejection of the newly transplanted organ, and Cymevene/Cytovene/Valcyte for the prevention and treatment of cytomegalovirus, a dangerous viral infection associated with transplantation. Roche has announced a co-development agreement with Isotechnika for their new medicine, ISATx 247, a potentially more potent and less toxic calcineurin inhibitor analogue. In addition, Roche supports basic research in transplantation with its funding of the independent Roche Organ Transplantation Research Fund (ROTRF), which directly supports innovative research projects attracting new researchers with innovative and novel scientific ideas to meet unmet medical needs in solid organ transplantation.

Headquartered in Basel, Switzerland, Roche is an innovation driven global healthcare leader focused on pharmaceuticals and diagnostics. Roche is world wide number one in diagnostics, oncology and transplantation and has a leading position in Virology. With products and services that address the prevention, diagnosis and treatment of diseases, the company contributes broadly to the enhancement of people's health and quality of life. Roche employs some 62,000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

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Notes to editors: –Primary source data taken from large renal transplant registries in North America/Europe
oThe UNOS database encompasses more than 250 kidney transplant centres located throughout the United States
oThe CTS encompasses more than 190 kidney transplant centres from around the world including: Austria, Belgium, Czech Republic, Finland, France, Germany, Great Britain, Greece, Hungry, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and Canada.

References:
1.Ojo AO, Meier-Kriesche HU, Hanson JA, et al. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation. 2000;69:2405-2409.
2.Blohmé, Ingemar and Brynger, Hans. Malignant disease in renal transplant patients. Transplantation 1985; 39: 1, 23-25
3.Kehinde EO et al. Triple therapy and incidence of de novo cancer in renal transplant recipients. British Journal of Surgery 1994, 81, 985-986.

For further information please contact:
Julia Pipe F. Hoffmann-La Roche International Communications Manager, Transplant Mobile tel: +41 79 263 9715
Office tel: +41 61 687 4376
Email: julia.pipe@roche.com

Lisa Marriott Ketchum
Office tel: +44-20-7611-3691
Email: lisa.marriott@ketchum.com


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