Media Release
Basel, 22 October 2003
Unique agreement
between Roche and Aspreva to develop CellCept in autoimmune diseases
Roche and Aspreva Pharmaceuticals Corporation today announced a collaboration to develop CellCept (Mycophenolate Mofetil/ MMF) in several autoimmune diseases.
CellCept is the leading immunosuppressant in transplantation. In over a decade of clinical experience CellCept has demonstrated that it provides potent immunosuppression, preventing organ rejection without the long-term toxic effects associated with other therapies.
Organ rejection is an immune reaction with many parallels to autoimmune disease. CellCept’s unique mode of action and positive efficacy and safety data in the transplant market suggest it could also benefit many autoimmune disease patients.
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 results so far have been seen in lupus (a disease causing chronic skin rash and affecting other body systems), myasthenia gravis (a disorder characterized by weakening of the muscles and fatigue, notably affecting the muscles of the mouth and throat), pemphigus vulgaris (a skin disease characterized by blisters that heal poorly) 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. This enables Roche to maintain focus on CellCept’s core market, transplantation, while extending the potential benefits of CellCept to a broader patient population.
Under the
terms of the deal Aspreva Pharmaceuticals has obtained exclusive worldwide rights (excluding Japan)
to develop and market CellCept in autoimmune disease applications. 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 better able to enhance the value of this key
Roche brand. Roche will stay focused on serving the needs of transplant patients, and Aspreva will undertake
the specialized development necessary to expand the use of CellCept into autoimmune disease,” said William
M. Burns, Head of Roche’s Pharmaceuticals Division.
Richard 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.”
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 burdens.
New data on CellCept in autoimmune diseases will be presented at the meeting of the American College of Rheumatology, Orlando, USA 25 - 28th October 2003. This will include a plenary session describing the potential role of CellCept in lupus nephritis, the most serious complication of systemic lupus erythematosus.
About
CellCept
CellCept was first approved in 1995 for renal transplant, and the indications
for CellCept now also include heart, liver and pediatric kidney transplants. In the USA CellCept is
the leading branded transplant medicine for the prevention of rejection, and it has been used to treat
approximately 593,000 transplant patients worldwide. In over a decade of clinical experience CellCept
has demonstrated that it provides potent immunosuppression, preventing organ rejection without the long-term
toxic effects associated with other therapies. CellCept prevents immune reactions through a unique mode
of action which is highly relevant for many autoimmune disease patients.
About
Autoimmune Diseases
Autoimmune diseases occur when the immune system attacks the
body’s own cells rather than invading microorganisms. There are more than 80 clinically distinct autoimmune
diseases, each affecting the body in different ways. Presentation of these diseases can also vary from
patient to patient with the same condition. For example, in lupus many parts of the body are affected,
especially the skin, joints, blood, and kidneys. But the extent to which each is affected can vary from
patient to patient. lupus nephritis – damage to the kidneys caused by autoantibodies - is the most serious
complication of systemic lupus erythematosus. It can lead to kidney failure requiring dialysis or transplant.
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. For example, no treatments have been
approved for lupus in over for 30 years, and the current standard of care, the cancer drug cyclophosphamide,
is associated with significant drug related morbidity.
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 research and development agreements with numerous partners, including majority ownership interests
in Genentech and Chugai.
About Aspreva
Aspreva
Pharmaceuticals is a specialty pharmaceutical company focused on addressing the needs of underserved
patient populations by developing new indications for approved medicines. Aspreva’s asset partnering
program allows its partners to maintain core brand focus while extending the benefits of their medicines
to a broader patient population.
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