Aspreva Pharmaceuticals Corporation and Roche today announced a unique collaboration which represents a new model for partnership between the pharmaceutical industry and the specialty pharmaceutical sector. Under the terms of the deal Aspreva Pharmaceuticals has obtained exclusive worldwide* rights to develop and commercialize CellCept® (mycophenolate mofetil) in all autoimmune disease applications. 

This novel indication partnering agreement enables Roche to maintain focus on CellCept's core market, transplantation, while extending the potential benefits of CellCept to autoimmune disease patients. Roche will register and invoice such sales as may result and will share the proceeds with Aspreva. 

“By bringing together the complimentary expertise of our two organizations, we are able to further enhance the value of this key Roche brand and better serve the needs of the transplant community. Aspreva will undertake the specialized development necessary to expand the use of CellCept into autoimmune disease.” said William M. Burns, Head of Roche's Pharmaceutical Division. 

Richard M. Glickman, Chairman and CEO of Aspreva Pharmaceuticals said: “Roche is an ideal partner for Aspreva. We share the same philosophy of providing high-quality evidence-based medicine that can help address the needs of underserved patient populations.” 

Frederick Frank, Vice Chairman Lehman Brothers Inc commented: “The extraordinarily large investment needed to bring new treatments to market has historically defined the size of the patient population that is necessary to make such developments both feasible and economically viable. The Roche Aspreva alliance represents a sought-after answer in addressing the pharmaceutical needs of patients with less common diseases. Roche has a history of creative structuring so it is no surprise that they have taken this lead. Hopefully this breakthrough partnership will be the first of many.” 

For several years physicians have been increasingly interested in investigating the use of CellCept in a variety of autoimmune diseases. Some of the most promising investigational study results so far are seen in Lupus, Myasthenia Gravis, Pemphigus Vulgaris and Autoimmune Hepatitis. 

Through the new collaboration, Aspreva will now build upon this evidence base by undertaking a global clinical program that will form the basis of formal regulatory submissions for CellCept in autoimmune diseases. 

There are more than 80 clinically distinct autoimmune diseases which collectively affect an estimated 5-8% of the population. In the US alone, as many as 22 million people are affected. Most of these conditions are highly debilitating and under-treated, creating significant social and financial burden. Corticosteroids are still the mainstay of treatment for many autoimmune diseases and physicians have to constantly balance the requirement for best possible disease control with the drug related morbidities associated with long term steroid exposure. 

Systemic lupus erythematosus (SLE) is one of the most prevalent autoimmune diseases and CellCept is a natural candidate for study in lupus nephritis (LN), the most serious complication of SLE. A substantial body of evidence exists regarding the safety and efficacy of CellCept in kidney transplant, where similar immunopathogenic processes are believed to occur. CellCept's specific immunomodulatory and antiinflammatory mechanisms, and the cardio-renal protective data from the transplant studies are highly relevant in LN. 

The Lupus Foundation of America (LFA) estimates that as many as 1.5 million people in the US suffer from lupus. Sandra Raymond, President and CEO of the LFA said: "No new medications for lupus have been approved for more than thirty years. Current treatments are toxic and cause debilitating side effects. Patients and physicians are eager for new drugs that can bring lupus under control without causing other serious health problems. The emerging data on CellCept in lupus is promising. I am very encouraged to see a major pharmaceutical company, in partnership with Aspreva, making a positive long-term commitment to improving the lives of patients with lupus.” 

New data on CellCept in autoimmune diseases will be presented at the American College of Rheumatology (ACR) meeting in Orlando, USA 25th-28th October 2003. This will include a plenary session describing the potential role of CellCept in lupus nephritis. Full results of this landmark trial comparing CellCept with the current standard of care will be presented at 10:30am Monday 27 October 2003. There is also an ACR press conference taking place at the Rosen Center in Orlando, FL entitled ‘New Treatments' Saturday 25th October, 2003 – 1:30pm – 2:30pm at which this data will be discussed.