Aspreva and Roche Announce Preliminary Results for Phase III Study Evaluating CellCept in Lupus Nephritis
Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that MMF was superior to IVC in inducing treatment response in this disease. The results relate to the induction phase of this study, which was designed to measure treatment response in patients after 24 weeks of induction therapy with 185 patients in the MMF arm and 185 in the IVC arm. The results indicate similar treatment responses with 56.2% in the MMF arm and 53% in the IVC arm were observed. Additional analyses are ongoing to determine the potential for a regulatory submission and Aspreva plans to present the final results at an appropriate scientific forum.
Based on preliminary analysis, it appears that, in general, the adverse events experienced by patients in both arms of the study are consistent with those observed in lupus nephritis patients receiving immunosuppressive therapy. Overall incidence of adverse events was comparable in both treatment arms. Aspreva will host a conference call today at 9:30 a.m. ET (6:30 a.m. PT) to discuss these preliminary results.
About Lupus Nephritis
Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints. Lupus nephritis, considered life-threatening, but rare, is the most serious manifestation of SLE. If left untreated, it can lead to kidney failure, need of dialysis, and potentially death. It is a complicated disease as patients typically fluctuate between periods of intense disease activity, during which the patient's own immune system is actively attacking and causing damage in their kidney, and periods of remission. Aspreva estimates that there are about 600,000 diagnosed lupus nephritis patients worldwide. There have been no new approved treatment options for SLE or lupus nephritis in the United States in over forty years. Current induction treatments involve the off-label use of existing cancer drugs such as cyclophosphamide, steroids, and immunosuppressants such as azathioprine. These treatments can also have life-threatening side effects that can be worse than the disease itself. Since the disease is more prevalent in women and tends to manifest itself when they are of child-bearing age, drugs that adversely affect fertility can also compound the negative impact of the disease on a patient's quality of life.
More About the Aspreva Lupus Nephritis Study
Aspreva's lupus nephritis study is one of the largest phase III studies ever conducted in lupus nephritis. This two-phase induction to maintenance study was designed as a randomized open label comparison of mycophenolate mofetil (MMF) with cyclophosphamide for the first six months (induction phase), followed by a double-blind comparison of MMF to azathioprine for up to three years (maintenance phase). Treatment response in the induction phase of this trial was defined as a decrease in proteinuria and the stabilization or improvement of serum creatinine. The first patient of this study was treated in July 2005 and patient enrollment was completed at the end of September, 2006. Re-randomization to the maintenance phase is complete and this phase of the study is ongoing. It is important to note that MMF is not currently approved by the FDA for the treatment of any autoimmune disease.
Aspreva will host a conference call to discuss results on Wednesday, June 27, 2007 at 9:30 a.m. ET (6:30 a.m. PT).
Dial-in information: North America (toll free): 1-866-713-8310 International: 1-617-597-5308 Enter passcode: 82004406
The call will be available for replay until Wednesday, July 5, 2007 by calling 1-888-286-8010 (North America) or 1-617-801-6888 (International) and entering the pass code 55009709. A live webcast will also be available to all interested parties on Aspreva's website: http://www.aspreva.com. Please click on the "Webcasts and Events" link under the Investors section of Aspreva's website. A replay of the webcast will be available until the Company's second quarter 2007 conference call.
CellCept (mycophenolate mofetil, MMF) is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants. There are no adequate and well-controlled studies in pregnant women. As CellCept has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy. Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information). Adverse events reported in more than 30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leucopenia (patients should be monitored for neutropenia; dosing should be interrupted or the dose reduced if neutropenia develops), thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia. Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
Warning: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
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 http://www.aspreva.com.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, 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 is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss franc ($26.6 billion US), and the Diagnostics Division posted sales of 8.7 billion Swiss franc ($6.96 billion US). Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information, about the Roche Group is available on the Internet at http://www.roche.com.
All trademarks used or mentioned in this release are protected by law.
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; 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 http://www.sec.gov and with securities regulatory authorities in Canada at http://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.
/For further information: Sage Baker, Vice President, IR & Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270,
Posted: June 2007