VICTORIA, March 30 /PRNewswire-FirstCall/ - Aspreva Pharmaceuticals Corporation , 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 patient enrolment in a global phase III clinical study. The study is designed to assess the safety and efficacy of CellCept(R) (mycophenolate mofetil) in association with corticosteroids to achieve remission in patients with active pemphigus vulgaris (PV).
The randomized, double-blind, placebo-controlled comparison study will investigate the efficacy and safety of mycophenolate mofetil in 77 patients with active PV over a treatment period of 52 weeks. The primary end point encompasses both minimal disease activity defined as no new persistent lesions, with a low steroid dose. The Company expects to complete the study in 2007.
"With the completion of patient enrolment in the second of our three global, phase III clinical trials currently underway, Aspreva has clearly demonstrated expertise in the development and execution of challenging clinical programs, and further reinforced the value proposition the Company offers to potential partners in the pharmaceutical industry. We are now one step closer in the development of a potentially new evidence-based treatment option for patients living with this rare disease," said Dr. Reinhard Baildon, M.D., Ph.D., Executive Vice President, Clinical & Regulatory Affairs at Aspreva.
About Pemphigus Vulgaris
Pemphigus Vulgaris (PV) is a rare, severe, chronic autoimmune disease that causes blisters of the skin and mucous membranes. According to the International Pemphigus Foundation, the disease affects approximately 40,000 people worldwide. People suffering from PV develop fragile skin blisters which may burst, leaving raw, crusted areas, which may cover large areas of the body's surface. Pemphigus vulgaris often begins with oral lesions, which may become painful, leaving patients unable to eat or drink, which may lead to malnutrition and debilitation.
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 July 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 any autoimmune disease including pemphigus vulgaris.
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".
For further information please contact: Sage Baker Executive Director, Corporate and Investor Affairs Aspreva Pharmaceuticals 250-744-2488 sbaker@aspreva.com
This press release contains forward-looking statements or information within the meaning of the Private Securities Litigation Act of 1995 and applicable Canadian Securities Legislation. These include, without limitation, statements or information related to our strategy, future operations, clinical trials, prospects and plans of management. Words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" and similar expressions are intended to identify forward- looking statements or information, although not all forward-looking statements or information contain these identifying words. These forward-looking statements or information are based upon our current expectations and we may not actually achieve the plans, approvals, intentions or expectations disclosed in our forward-looking statements or information. Forward-looking statements or information involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements or information as a result of these risks and uncertainties, which include, without limitation, risks related to difficulties or delays in 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, difficulties or delays in obtaining regulatory approval, the FDA may finally determine that the design and planned analysis of our clinical trials 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 or information, which speak only as of the date of this press release. All forward-looking statements or information are qualified in their entirety by this cautionary statement, and Aspreva undertakes no obligation to revise or update any forward-looking statements or information as a result of new information, future events or otherwise after the date hereof.
Aspreva PharmaceuticalsCONTACT: Sage Baker, Executive Director, Corporate and Investor Affairs,Aspreva Pharmaceuticals, (250) 744-2488, sbaker@aspreva.com
