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Cellcept

Mycophenolate mofetil (MMF, trade names Cellcept® and Myfortic®) is an immunosuppresant drug used to prevent rejection in organ transplantation. more...

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It is metabolised in the liver to mycophenolic acid which inhibits inosine mononophosphate dehydrogenase, the enzyme which controls the rate of synthesis of guanine monophosphate in the de novo pathway of purine synthesis used in the proliferation of lymphocytes.

MMF is a therefore a potent anti-proliferative, and can be used in place of the older anti-proliferative azathioprine. It is usually used as part of triple therapy including a calcineurin inhibitor (cyclosporine or tacrolimus) and prednisolone.

Compared with azathioprine, it is more lymphocyte-specific, causes less bone marrow suppression and is associated with fewer opportunistic infections. It is also associated with a lower incidence of acute rejection. MMF does cause gastro-intestinal side effects, however, including severe diarrhoea.

The exact role of MMF vs. azathioprine has yet to be conclusively established, but many centres use it in place of azathioprine for high-risk patients, or patients who have already experienced an episode of acute rejection. In long-term immunosuppression, it may be used to avoid calcineurin inhibitors or steroids.

MMF is used experimentally in ITP (immune thrombocytopenic purpura) and Lupus Erythematosus.

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Aspreva Announces Completion of Patient Enrolment in Phase III Clinical Trial for CellCept in Myasthenia Gravis
From PR Newswire, 11/28/05

VICTORIA, BC, Nov. 28 /PRNewswire-FirstCall/ -- Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV), an emerging pharmaceutical company focused on increasing the pool of evidence-based medicines available for patients living with less common diseases, today announced completion of enrolment of 176 patients in the phase III clinical study to assess the safety and efficacy of mycophenolate mofetil (MMF or CellCept(R)) to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis (MG).

The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of MMF to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoint of responder status in the trial encompasses both minimal disease activity and low steroid dose. The company expects to complete the trial in late 2006.

"The completion of enrolment for our global phase III study of MMF in MG has been achieved on schedule. This success reflects the strong interest from both patients and clinical investigators in the potential of MMF in treating this debilitating and life-threatening condition as well as our expertise in developing and executing effective clinical programs for rare diseases. We look forward to completing the study late next year," said Dr. Reinhard Baildon, M.D., Ph.D., Executive Vice President, Clinical & Regulatory Affairs at Aspreva.

About Myasthenia Gravis

According to the Myasthenia Gravis Foundation, myasthenia gravis (MG) affects approximately 70,000 to 100,000 people worldwide, including approximately 36,000 people in the United States. MG is a debilitating, chronic autoimmune neuromuscular disease in which the body produces auto- antibodies which prevent the nerves from sending messages to the muscles.

Although MG can affect any voluntary muscle, it frequently involves those controlling eye movements, chewing, swallowing, coughing and facial expressions, but can be more severe in some of the affected patients.

Complete remission is infrequent and long-term immunosuppression is usually required. Current treatments of MG include the use of cholinesterase inhibitors, steroids and other immunosuppressant drugs such as azathioprine.

About CellCept

CellCept is F. Hoffmann-La Roche's (Roche) leading immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants. CellCept was first approved for use in combination therapy for the prevention of acute organ rejection in kidney transplantation in 1995 and has since been approved worldwide for prevention of organ rejection in adult kidney, heart and liver transplantation. In some countries, it has also been approved for paediatric kidney transplantation. This therapeutic success represents 10 years of clinical experience and patient benefits, including reduced toxicities and prolonged graft and patient survival. Over the last decade, CellCept has become the world's most widely studied immunosuppressant and research is ongoing both in organ transplantation and related areas, such as autoimmune disease, to help provide clinical benefit to a wider range of patients.

In October 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights (excluding Japan) to develop and upon regulatory approval, commercialize CellCept for all autoimmune disease applications.

CellCept is not currently approved for the treatment of myasthenia gravis.

About Aspreva Pharmaceuticals

Aspreva is an emerging pharmaceutical company focused on identifying, developing and, upon regulatory approval, commercializing new indications for approved drugs and late stage drug candidates for patients living with less common diseases. Aspreva's "Indication Partnering" strategy allows its partners to maintain core brand focus while extending the benefits of their medicines to a broader patient population. Aspreva is listed on the Nasdaq National Market under the trading symbol "ASPV" and on the Toronto Stock Exchange under the trading symbol "ASV".

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Act of 1995. These include without limitation statements related to our clinical trials, product candidates and operations. Words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward- looking statements contain these identifying words. These forward-looking statements are based upon our current expectations and we may not actually achieve the plans, approvals, intentions or expectations disclosed in our forward-looking statements. Forward-looking statements involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of our clinical trials, our ability to attract and retain collaborations relating to the development and commercialization of new indications, intellectual property matters, difficulties or delays in obtaining regulatory approval, the FDA may finally determine that the design and planned analysis of our clinical trail do not adequately address the trial objectives in support of our regulatory submission, competition from other pharmaceutical or biotechnology companies, and other risks detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Aspreva undertakes no obligation to revise or update any forward-looking statements as a result of new information, future events or otherwise after the date hereof.

CONTACT: Sage Baker, Director, Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 270, sbaker@aspreva.com

COPYRIGHT 2005 PR Newswire Association LLC
COPYRIGHT 2005 Gale Group

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