VICTORIA, Oct. 11 /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 reported Aspreva’s analysis of the data of an 80 patient investigator initiated trial (IIT) led by Donald Sanders, M.D of Duke University Medical Center with The Muscle Study Group, a consortium of academic centers, Durham, North Carolina. The double-blind, placebo-controlled IIT supported by the Food and Drug Administration’s (FDA’s) Office of Orphan Products Development, Roche and Aspreva, evaluated the effect of the initiation of treatment with prednisone and CellCept(R) (mycophenolate mofetil or MMF) in comparison to prednisone alone on the signs and symptoms of myasthenia gravis in patients who were not on corticosteroids and had not previously received other immunosuppression.
Aspreva’s analysis of the data generated from Dr. Sanders’ IIT showed that after 12 weeks of treatment, the efficacy of MMF and 20mg of prednisone was no different from the efficacy of 20mg prednisone alone. This conclusion is based on the Qualitative Myasthenia Gravis (QMG) score, a questionnaire that evaluates signs and symptoms of myasthenia gravis. Aspreva’s analysis also showed that MMF appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, insomnia and muscle spasms. Dr. Sanders and his co-investigators are preparing a full report of the study and its findings, which will be submitted for publication to a peer-reviewed medical journal and presented at an appropriate medical conference.
Aspreva is conducting a multinational, double-blind, placebo-controlled phase III study. Aspreva’s study is designed to evaluate the effects of MMF on the signs and symptoms of myasthenia gravis in 176 patients who have been previously treated with corticosteroids.
In contrast to Dr. Sanders’ IIT, the primary end point of Aspreva’s phase III study is adequate disease control with steroid sparing. Steroid-sparing, an important treatment goal of immunosuppression because of the severe side effects associated with prolonged steroid use, could not be evaluated in Dr. Sanders’ study due to the nature of the design. In addition, MMF is administered for 36 weeks in Aspreva’s study; treatment duration longer than 12 weeks may be necessary to demonstrate a potential effect in myasthenia gravis.
Aspreva intends to submit the data from Dr. Sanders’ IIT into any regulatory filings Aspreva and Roche may make seeking approval of CellCept in the treatment of myasthenia gravis. Database lock on this trial is anticipated later this month with results from Aspreva’s study available later this quarter.
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 Roche’s 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 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.
In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights 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.
There are no adequate and well-controlled studies of CellCept 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 > 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.
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. For full prescribing information on CellCept, please visit: www.rocheusa.com/products/cellcept.
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 is listed on the Nasdaq Global Select Market under the trading symbol “ASPV” and on the Toronto Stock Exchange under the trading symbol “ASV”.
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 release of full study results from IIT; Aspreva’s own multinational, double-blind, placebo-controlled phase III study; Aspreva’s expectation that its study will evaluate the effect of MMF on steroid-sparing; Aspreva’s expectation that its trial design will show that MMF addresses the long term need of patients through steroid tapering, improved disease control and support of the MMF safety profile; Aspreva’s intention to integrate the safety data from Dr. Sanders’ IIT with the results from Aspreva’s phase III study when Aspreva and Roche apply for regulatory approval of CellCept in the treatment of myasthenia gravis in the second quarter 2007; and Aspreva’s expectation that database lock on this trial is anticipated later this month. Readers are cautioned that the plans, intentions or expectations disclosed in any forward-looking statements 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; our ability to attract and retain collaborations relating to the development and commercialization of new indications; 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; 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. Other risks, uncertainties and factors that our management believes could cause actual results or events to differ materially from the forward-looking statements are discussed in our filings with the Securities and Exchange Commission and securities regulatory authorities in Canada. 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, Vice President, Investor Relations and Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270, sbaker@aspreva.com
Aspreva Pharmaceuticals
CONTACT: Sage Baker, Vice President, Investor Relations and CorporateCommunications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270,sbaker@aspreva.com
