VICTORIA, May 22 /PRNewswire-FirstCall/ - Aspreva Pharmaceuticals Corporation today announced successful completion of patient enrollment in their global phase III clinical trial 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.
The total number of patients enrolled in this pemphigus vulgaris study is 96. Today’s announcement represents a new patient total for this trial following the re-opening of patient recruitment in late 2006 as a result of a protocol amendment requested by the US Food & Drug Administration to increase the statistical power of the study.
Dr. Usman Azam, Aspreva’s Chief Medical Officer, said: “By strengthening the statistical power of this study, we have improved our ability to assess the potential efficacy of mycophenolate mofetil in the treatment of this complicated and rare disease. Ultimately our goal is to add to the pool of evidence-based treatment options for patients with less common diseases and this study is another step towards that goal.”
This randomized, double-blind, placebo-controlled comparison study is designed to investigate the efficacy and safety of mycophenolate mofetil in patients with active pemphigus vulgaris 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. Aspreva expects to complete the study in 2008.
About Pemphigus Vulgaris
Pemphigus Vulgaris is a rare, severe, and 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 this disease 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 Roche’s leading immunosuppressant or “anti-rejection” drug. It is 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. This therapeutic success in the prevention of organ rejection in adult kidney, heart and liver transplantation represents 11 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.
It is important to note that CellCept has not been approved by the FDA for the treatment of any autoimmune disease, including pemphigus vulgaris.
About Aspreva Pharmaceuticals
Aspreva is a global pharmaceutical company focused on identifying, developing, and, upon approval, commercializing evidence-based medicines for patients living with less common diseases. Aspreva common stock is traded on the NASDAQ Global Select Market under the trading symbol “ASPV” and on the Toronto Stock Exchange under the trading symbol “ASV”. Learn more at www.aspreva.com.
This news release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable securities laws in Canada (collectively, “forward-looking statements”). The words “anticipates”, “believes”, “budgets”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “projects”, “schedule”, “should”, “will”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this news release include, but are not limited to, statements about: our strategy, future operations, clinical trials, prospects and plans of management; our ability to evaluate the potential efficacy of mycophenolate mofetil in the treatment of pemphigus vulgaris; the effects of CellCept on patients; our expectations with respect to our existing collaboration agreement with Roche for the development of CellCept in autoimmune indications; and our two phase III clinical programs underway with CellCept: lupus nephritis and pemphigus vulgaris.
With respect to the forward-looking statements contained in this news release, we have made numerous assumptions regarding, among other things: our ability to predict the effects of CellCept on patients; our ability to continue our two phase III clinical programs underway with CellCept: lupus nephritis and pemphigus vulgaris; our ability to protect our intellectual property rights and to not infringe on the intellectual property rights of others; our ability to comply with applicable governmental regulations and standards; and our ability to succeed at establishing a successful commercialization program for any of our potential products. Readers are cautioned that the plans, intentions or expectations disclosed in any forward-looking statements and underlying assumptions may not be achieved and that they should not place undue reliance on any forward-looking statement. Actual results or events could differ materially from the plans, intentions, expectations, and assumptions expressed or implied in any forward-looking statements as a result of numerous risks, uncertainties and other factors, including those relating to: difficulties or delays in the progress, timing and results of clinical trials and studies; difficulties or delays in obtaining regulatory approvals; the FDA may determine that the design and planned analysis of our clinical trials do not adequately address the trial objectives in support of our regulatory submission; future sales of CellCept may be less than expected; our future operating results are uncertain and likely to fluctuate; we may not be able to develop and obtain regulatory approval for CellCept in the treatment of autoimmune indications and any future products in our targeted indications; we may not be able to establish marketing and sales capabilities and the costs of launching CellCept in the treatment of autoimmune indications and any future products for our targeting indications may be greater than anticipated; the risk that we may not sustain our profitability; our ability to attract and retain collaborations relating to the development and commercialization of new indications; competition from other pharmaceutical or biotechnology companies; our ability to raise additional financing required to fund further research and development, clinical studies, and obtain regulatory approvals, on commercially acceptable terms or at all; economic and capital market conditions; our ability to obtain and protect patents and other intellectual property rights; our ability to operate without infringing the intellectual property rights of others; our ability to comply with applicable governmental regulations and standards; currency exchange rates; and our ability to successfully attract and retain skilled and experienced personnel.
For a more thorough discussion of the risks associated with Aspreva’s business, see the “Risk Factors” section in Aspreva’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, filed with the U.S. Securities and Exchange Commission at www.sec.gov and with securities regulatory authorities in Canada at www.sedar.com. Although we have attempted to identify important risks, uncertainties and other factors that could cause actual results or events to differ materially from those expressed or implied in the forward-looking statements, there may be other factors that cause actual results or events to differ from those expressed or implied in the forward-looking statements. 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, VP, Investor Relations & Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270, sbaker@aspreva.com
Aspreva Pharmaceuticals
CONTACT: Sage Baker, VP, Investor Relations & Corporate Communications,Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270, sbaker@aspreva.com
