Data shows life of kidney transplant lengthened by CellCept®

August 29, 2002

Study results presented today at the XIXth International Congress of the Transplantation Society (ICTS) Miami, USA, show that when kidney transplant patients with deteriorating kidney function switched to the low toxicity immunosuppressant CellCept® (mycophenolate mofetil, MMF), kidney deterioration reversed and significantly improved, thus halting the progression towards kidney loss, and improving patients outcomes.

Kidneys are the most commonly transplanted organ with 30,000 transplanted world-wide each year, but the number of patients waiting for a kidney massively exceeds this, at 120,000 world-wide. It is therefore critical to lengthen the lifespan of the transplanted kidney by reducing the drugs that cause toxicity in the transplanted kidney, which can lead to kidney loss and the need for another transplant.

"The lack of organs and the growing number of patients needing them is of great concern. Therefore, anything we can do to help patients keep their transplanted kidney for longer is beneficial to everyone," comments Dr Helio Tedesco, Chief of Clinical Investigation of the Federal University of São Paulo, Brazil.

"We have known for many years that the continued use of calcineurin inhibitors such as cyclosporine is one of the factors associated with increased kidney toxicity, contributing to progressive kidney failure and, eventually, kidney loss. In this trial, we have seen that when cyclosporine is substituted with CellCept®, we were able to reverse some of the cyclosporine-associated toxic effects and halt the progression of the damage to the kidney in the majority of the patients, thereby lengthening the life span of the transplanted kidney," continued Dr Tedesco.

"These are important data. If the one-year findings of this trial represent what we will find in five years' time, patients can hope to experience a profound improvement in their quality of life, thanks to this switch in therapy. CellCept® provides patients with a non-kidney toxic treatment which not only has the ability to prevent them from rejecting their organ, but also retains their transplanted kidneys for longer."
Notes to Editors:

* The yearlong study of 143 kidney transplant patients who were showing signs of deteriorating kidney function set out to discover whether CellCept® could effectively replace cyclosporine and improve kidney function
* The results show that 58% of patients on CellCept® therapy without cyclosporine had a reversal or stabilisation of their kidney function compared to 32% of patients who continued on cyclosporine, as measured by decreasing serum creatinine levels (an indication of kidney function)
* The results also demonstrate that cyclosporine was withdrawn from the patients and CellCept® added to their regimen safely, without increasing the risk of adverse events, including acute rejection, raised blood pressure levels, graft loss and patient death
* Cyclosporine therapy has long been the mainstay of immunosuppressive treatment in renal transplantation despite its known toxic effect on the kidney, which can cause kidney failure and transplant loss
* CellCept®, a newer immunosuppressant drug, has been shown to have a non-kidney toxicity profile1 compared to other immunosuppressants and this allows for improved kidney function whilst minimising the risk of organ rejection

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 has been developed for the prevention and treatment of cytomegalovirus, a dangerous viral infection associated with transplantation. Recently, Roche have announced a co-development agreement with Isotechnika for their new medicine, ISATx 247, a potentially more potent and less toxic calcineurin inhibitor. 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 one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well being and quality of life.

1. Danowitch G. Transplantation Reviews (2000) 14: 65-81.
All trademarks used or mentioned in this release are legally protected.

Ketchum UK

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