New data supports CellCept's position as a world leader in solid organ transplantation

May 19, 2004

19 May 2004, Basel, Switzerland - New data presented this week in over 70 abstracts at the American Transplant Congress in Boston, USA strengthen even further the body of evidence that CellCept® (mycophenolate mofetil, MMF) is the most reliable, efficacious, low toxic immunosuppressant for adult and paediatric kidney, heart and liver transplant patients.

The collective data presented at the ATC, in which more than 61,000 transplant patients where studied, demonstrate that CellCept-based therapies have unique benefits for solid organ transplant patients such as:"In order for us to choose the best immunosuppressant regimen for our patients, we need to consider acute rejection, long term graft function, minimal toxic side-effects and, most importantly, graft and patient survival", said Prof Meier- Kriesche, University of Florida, Gainsville, FL, USA. "Long term data with meaningful patient numbers, data and experience from our peers, allows us to decide on the best low toxic combination for better outcomes and patient survival. CellCept's 10 years of clinical experience, in addition to early clinical trials, provides us that real world data", he added.

Highlights from the wealth of data presented at ATC
... in adult liver transplant patients
Lake R, Chu AH, Steffen BJ, et al. Efficacy of triple therapy with mycophenolate mofetil (MMF), tacrolimus (TACRO) and corticosteroids (CS) compared to TACRO and CS immunosuppression in liver transplantation: an analysis of the US liver transplant experience. Abstract 395, ATC 2004. CellCept reduced acute rejection rates in a study of 11,670 liver transplant patients, when added to a tacrolimus based immunosuppressant regimen. Graft and patient survival significantly improved (p<0.0001), whilst the risk for infectious death was reduced (p=0.02).

Fasola CG, Netto GJ, Sanchez EQ, et al. Hepatitis C recurrence (HCVR) in liver transplant recipients (OLT) under mycophenolate mofetil (MMF) immunosuppression (IS): A long-term follow-up. Abstract 728, ATC 2004.
79 liver transplant patients with hepatitis C, patients kept on a CellCept regimen presented lesser hepatitis C recurrence and disease progression at five years, compared to patients who had been on CellCept treatment for less than three years. This may suggest that the length of time at which transplant patients are treated with CellCept is positively associated with better liver function outcomes.

... in adult heart transplant patients
Russell SD, Kobashigawa JA, Miller LW, et al. A randomised, prospective, multicenter comparison of tacrolimus, mycophenolate mofetil (MMF) and steroids vs. cyclosporine (modified USP), MMF and steroids vs. tacrolimus, sirolimus and steroids in de novo cardiac transplant recipients -6 month report. Abstract 451, ATC 2004.
In a study of 650 heart transplant patients, a new set of data compiled by means of state of the art technology(1) shows that heart transplant patients treated with CellCept have significantly less coronary artery disease (the predominant cause of post-transplant death) 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 for CellCept.

Trochu J-N, Redonnet M, Lelong B, et al. The addition of mycophenolate mofetil to low-dose cyclosporine A-based immunosupression improves renal function in heart transplant patients. Abstract 61, ATC 2004.
CellCept is associated with a long-term improvement of renal function, when used as part of a low-dose (50% reduction) CNI-based treatment regimen in heart transplant patients with chronic kidney impairment. Improvements as measured by decreasing serum creatinine levels were observed over two years, reinforcing CellCept's nephroprotective profile.

Grostzner J, Kaczmarek I, Mueller M, et al. Calcineurin-inhibitor-free immunosuppression with mycophenolate mofetil and sirolimus after cardiac transplantation is safe and improves renal function significantly: 1 year follow-up. Abstract 449, ATC 2004.
In this study of 30 heart transplant patients data showed that conversion from a CNI-based immunosuppressant regimen to CellCept and sirolimus in patients with chronic kidney failure is safe, preserves graft function and improves kidney function. This may help avoid CNI-related nephrotoxicity, a common problem after heart transplantation, which can lead to increased morbidity and impairment of patients' quality of life.

... in adult kidney transplant patients
Abramowicz D, Gafner N, Wijngaard P. Cyclosporine withdrawal from a mycophenolate mofetil-containing immunosuppressive regimen: results of a five-year, prospective, randomised study. Abstract 1527, ATC 2004.
In a study of 151 stable renal transplant patients, where CNI was withdrawn from a CellCept-based immunosuppressant regimen, there was no impact on five-year graft and patient survival. Beneficial effects were observed in kidney function, as well as lipid profile, blood pressure and malignancy rate. These data show that CellCept is safe to use long term as part of a low-toxicity immunosuppressant regimen and allows CNI-sparing, thus avoiding associated kidney toxicity, high cholesterol and high blood pressure, which can lead to impaired graft function.

Kessler M, Frimat L, Charpentier B, et al. Renal function evaluation after half dose reduction of Neoral® in combination with CellCept® in renal transplant patients with altered renal function: preliminary 2 year safety and efficacy results of the MMF - REFERENCE study: a randomised, open, multicentre, prospective, controlled study. Abstract 462, ATC 2004.
Further data shows CellCept's CNI-sparing benefit in patients with impaired graft kidney function given a 50% reduced dose of CNI, within a CellCept-based immunosuppressant regimen. Results indicate that over two years, kidney function within the CellCept group improved, whereas the CNI/azathioprine (AZA) group saw no improvements in graft function.

... in children with a kidney transplant
Jungraithmayr TC, Tönshoff B, Zimmerhackl LB, et al. Mathematical modelling to predict renal function and graft survival based on 5 year data of paediatric renal transplant patients with mycophenolate mofetil (MMF) versus azathioprin (AZA) based immunosuppression. Abstract 1355, ATC 2004.
CellCept-based immunosuppressant regimens lead to longer-term healthy graft function and survival in children (89.9%), when compared to AZA-based therapies (73.1%). This is according to data revealed through a novel mathematical model, which outlined future graft survival and functioning rates based on existing five-year data. In addition, CellCept maintained normal creatinine levels - an indicator of healthy kidney function - for twice as long as the AZA group (14.5 years versus 6 years).

... in allograft dysfunction in adult patients
Two further studies reinforced CellCept's position as central to a safe, effective and tolerable immunosuppressant regimen.

Fonseca CC, Felipe CR, Motegi SA, et al. Conversion from cyclosporine/sirolimus (CsA/SRL) to mycophenolate mofetil/sirolimus (MMF/SRL) in patients with chronic allograft dysfunction. Abstract 226, ATC 2004.
In a study of 182 transplant patients where 81 patients presented with allograft dysfunction, conversion from CNI/sirolimus to CellCept/sirolimus in patients with chronic allograft dysfunction is a potential effective and safe strategy to preserve graft function.

Alves EC, Felipe CR, Park SI, et al. Long-term effects of the conversion from azathioprine (AZA) to mycophenolate mofetil (MMF) in patients with chronic allograft dysfunction (CAD). Abstract 228, ATC 2004.
In this study of 167 transplant patients, conversion from AZA to CellCept followed by CNI dose reduction or withdrawal is a safe and effective strategy in preserving or improving graft function and therefore prolonging allograft survival.

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, 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. Valcyte was 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.

For further information please contact:
Julia Pipe
International Communications Manager, Transplant
Mobile tel: +41 79 263 9715
Office tel: +41 61 687 4376

Cendrine Banerjee-Quetel
Office tel: +44 20 7611 3656

All trademarks used or mentioned in this release are legally protected.

(1) The study used intravascular ultrasound, a tool used to evaluate the effectiveness of therapies after heart transplantation, using high-frequency sound waves to produce detailed pictures of the arteries.

Ketchum UK

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