Liver Transplant Patients Gain Same Positive Benefits from CellCept® as Kidney Transplant Patients

May 25, 2005

Basel, Switzerland -- New data reported in over 90 abstracts presented at the American Transplant Congress in Seattle show that liver transplant patients taking CellCept are gaining the same positive benefits already demonstrated in kidney transplant patients. This is good news for patients as the demand for liver transplants is increasing, with many cases directly resulting from chronic hepatitis C virus (HCV) infection.

The benefits seen with CellCept include:

• Reduced risk of acute rejection, especially in patients infected with HCV - graft rejection is of particularly high risk in HCV patients and is associated with increased morbidity and decreased patient and graft survival (Abstract 928)
• Safe and effective steroid-free regimens for HCV patients - steroids are known to have a negative impact on the progression of HCV, which can result in liver fibrosis (Abstract 475)
• Optimal kidney function - CellCept taken with a low dose of tacrolimus showed a trend towards improved kidney function (Abstract 1240). CellCept is proven to promote excellent kidney function early after kidney transplantation in renal patients taking tacrolimus[i]
• Less liver fibrosis - recipients taking CellCept-based regimens showed a significant reduction in the inflammation and structural changes that can lead to liver failure (Abstract 1446)
• No increased risk of malignancy - the addition of CellCept to maintenance immunosuppression that includes tacrolimus and corticosteroids did not increase the risk of death due to malignant complications (Abstract 930). This confirms previous data as seen in kidney transplant recipients[ii]

"It's really exciting to see liver transplant recipients benefiting from CellCept in the same way as kidney transplant patients. Our aim is to find the most effective, least toxic immunosuppressive regimen for our patients so we can ensure that they enjoy a long, healthy and active life post transplant," said Dr. Bjorn Nashan, Dalhousie University, Halifax, NS, Canada. "CellCept's unrivalled 10 years of data show the impact that effective, low toxic regimens have had on improving long-term outcomes and patient survival."

Liver transplantation has become a widely accepted and effective therapy for a number of irreversible acute and chronic liver diseases. These can include cancer of the liver and bile ducts, viral hepatitis as well as liver cirrhosis. One-year survival has reached 90% and three-year survival is 80%.[iii]

CellCept, with over 10 years of evidence base and clinical experience, is the only mycophenolic acid (MPA) derivative indicated for liver, kidney and heart transplant patients and is currently prescribed to more than half the liver transplanted population[iv]. CellCept is also the only MPA derivative with proven survival benefits for liver, kidney and heart transplant recipients.[v],[vi],[vii]

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 research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, 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 is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

Abstract highlights from the wealth of CellCept data presented at ATC 2005

• Abstract 928: Weisner R, David K, Steffen B et al. Recipient risk factors predict risk of rejection in adult liver transplant recipients. Various factors including cause of underlying liver disease, year of transplant, age of recipient and ethnicity were associated with risk of rejection. The addition of MMF to tacrolimus-based immunosuppression was associated with a decreased risk of rejection. These results may help in the design of patient-specific immunosuppression regimens.
• Abstract 475: Fasola M, Heffron T, Sher L, et al. Multicentre randomised hepatitis C three trial post liver transplantation: a one-year follow up report. This one-year preliminary report suggests that steroid-free immunosuppression with tacrolimus, MMF and daclizumab may be a safe option for HCV+ liver transplant recipients. There were no significant differences between patient or graft survival, HCV recurrence or various adverse events. Low acute rejection rates in the MMF arms is encouraging as most acute rejection occurs within the first year post liver transplant.
• Abstract 1240: Marotta P, Nashan B, Saliba F, et al. Low tacrolimus exposure in combination with MMF is safe and effective compared to standard tacrolimus exposure following liver transplant. The aim of this study was to compare the pharmacokinetic profiles of MMF with different levels of tacrolimus (and in combination with corticosteroids). The safety and efficacy profiles were similar in patients receiving standard or reduced levels of tacrolimus in combination with MMF, and possibly in favour of a reduction in tacrolimus since creatinine clearance (hence kidney function) was improved in this group.
• Abstract 1446: Kato T, Yoshida H, Gaynor J, et al. Impact of steroid-free induction, MMF and pre-emptive antiviral therapy for liver transplant. Liver transplant recipients with HCV tolerated the steroid free protocol with lower side effects. Use of MMF and/or pre-emptive antiviral therapy was the only variable to significantly reduce the progression of fibrosis in the first year after transplant (p=0.01).
• Abstract 930: Wida S, Cherikh H, Kauffman B, et al. Association of different immunosuppressive regimens with post transplant de novo malignancies in liver recipients. De novo malignancies are responsible for over one in five deaths reported to OPTN/UNOS in liver recipients surviving at least 5 years. The addition of MMF to maintenance immunosuppression that includes tacrolimus and corticosteroids did not increase the risk of death due to malignant complications.

For further information please contact:

Julia Pipe

Roche

International Communications Manager, Transplant

Mobile tel: +41 79 263 9715

Office tel: +41 61 687 4376

Email: julia.pipe@roche.com

http://www.roche.com

Vicky Singlehurst

Ketchum

Senior Account Executive

Office tel: +44 20 7611 3523

Email: vicky.singlehurst@ketchum.com

Georgina Hunt (onsite contact)

Ketchum

Account Director

Mobile: +44 (0)7739 779297

Copyright © 2003-2005 Medical News Today.

This article posted July 6, 2005.