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Basel, 22 April 2004

CellCept's cardioprotective profile reinforced
Data further strengthens CellCept's unique benefits for heart transplant patients

Data presented today1 at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting strengthens the body of evidence that CellCept (mycophenolate mofetil, MMF) has unique benefits for heart transplant patients as the only immunosuppressant that offers:
• superior survival benefits2
• reduced coronary artery disease3
• the least toxic side effect profile4

The new set of data, compiled by means of state of the art technology, has shown that heart transplant patients treated with CellCept have significantly less coronary artery disease than those treated with azathioprine (AZA) in the first year after heart transplantation (p</=0.005). This finding could further explain the superior survival benefits of CellCept.

For heart transplant patients, cardiovascular disease is the predominant cause of post-transplant death.3
The body’s own immune response to the transplanted organ, and the cocktail of drugs taken by the patient cause an increase in coronary artery disease and other risk factors such as hypertension, diabetes and hyperlipidaemia.5 However, unlike other immunosuppressants, CellCept is NOT associated with these risk factors.6,7,8

“These results add to the body of evidence demonstrating the superior efficacy, low-toxicity and cardioprotective profile of CellCept. They show CellCept to offer real long-term benefits to patients, both in terms of overall patient survival and health of the graft,” comments William M. Burns, Head of Roche’s Pharmaceuticals Division. “CellCept has boosted prescriber confidence and is the ideal cornerstone immunosuppressive agent for ‘heart healthy’ treatment regimens.”

About the study
A total of 650 heart transplant patients from 28 centres were enrolled in the pivotal trial. Patients were then randomly assigned to receive CellCept (3000mg/day) or azathioprine (1.5-3.0 mg/kg/day), in addition to cyclosporine and corticosteroids.

IVUSa results, including an increase in MITb (measures the thickening of the wall of the coronary artery) of at least 0.3mm from baseline to one-year, are widely considered to be a marker for poor long-term outcome after heart transplantation. The analysis showed that a significantly larger number of patients treated with azathioprine had first year MIT of >/=0.3 mm compared to those treated with MMF.

About CellCept
CellCept is the cornerstone of low toxicity immunosuppressant therapy. It has been available to patients for 10 years, initially through clinical trials and more widely since 1995, following licence approval as a key component of the maintenance immunosuppression used in patients at risk of organ rejection following kidney transplant. CellCept has also been approved for prevention of rejection in heart, liver and paediatric kidney transplant in 1998, 2000 and 2001 respectively.

Over this time, CellCept has become one of the world’s most widely studied immunosuppressant and with more than 275,000 patients having received the drug worldwide, it is the largest selling branded immunosuppressive in North America today.

For CellCept, this therapeutic success represents a decade of patient experience, built on a foundation of rigorous and landmark clinical trials that have set the standards for clinical research in solid organ transplant. Data from these trials and long term follow up show that CellCept prolongs organ graft and patient survival, is safe with a low toxicity profile and is also associated with a reduced risk of post transplant malignancy.

CellCept’s innovative clinical trials programme continues to offer therapeutic solutions to unmet clinical needs. Research is ongoing in organ transplantation and autoimmune disease, to help provide clinical benefit to a wider range of patients and reduce their reliance on more toxic agents.

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 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 Valcyte developed for the prevention of cytomegalovirus, a dangerous viral infection associated with transplantation. 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.

About Roche
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 number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and 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 a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.

Further information:
Roche in transplantation
a IntraVascular UltraSound
b Maximal Intimal Thickness

1 Kobashigawa J. Further analysis of the intravascular ultrasound (IVUS) data from the randomised mycophenolate mofetil (MMF) trial in heart transplant recipients. 2004. Data presented at the 24th Annual Meeting of the ISHLT, San Francisco, CA, USA, 21 April 2004
2 Kobashigawa J, Miller l, Renlund D, et al. A randomised active-controlled trial of mycophenolate mofetil in heart transplant patients. Mycophenolate Mofetil Investigators. Transplantation 1998;66:507-15
3 Hosenpud JD, Bennett LE. Mycophenolate mofetil versus azathioprine in patients surviving the initial cardiac hospitalization: an analysis of the Joint UNOS/ISHLT Thoracic Registry. Transplantation 2001;72:1662-1665
4 Danovitch GM. Immunosuppressive medications for renal transplantation: A multiple choice question. Kidney Int. 2001;59:388-402
5 Kasiske BL, Chakkera HA, Roel J. Explained and unexplained ischemic heart disease risk after renal transplantation. J Am Soc Nephrol. 2000;11:1735-1743
6 Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation. 1995;60:225-232
7 Ballantyne CM, Podet EJ, Patsch WP, et al. Effects of cyclosporine therapy on plasma lipoprotein levels. JAMA. 1989;262:53-56
8 Groth CG, Backman L, Morales JM, et al. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation. 1999;67:1036-1042

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