Sunday, September 30, 2007
Bayer Schering Pharma AG, Germany, and Genzyme Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
Berlin, September 26, 2007 – Bayer Schering Pharma AG, Germany, and Genzyme Corporation, USA, today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).
The CARE-MS SM I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif® (interferon beta-1a) in patients with relapsing-remitting MS. Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.
Initiation of this Phase 3 program follows the successful completion of the initial treatment period in the Phase 2 trial. Interim results from the Phase 2 trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction in the risk for sustained accumulation of disability and the risk for relapse for 24 months compared with Rebif-treated patients. Results of the primary outcomes from this trial at 36 months are expected to be presented on Oct. 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, in Prague.
The CARE-MS I study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe, and will again compare alemtuzumab-treated patients to Rebif-treated patients according to two co-primary endpoints: the time to sustained accumulation of disability and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for five days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for three days. All patients will be followed for two years from the date that the last patient is randomized to treatment. Alemtuzumab-treated patients will continue to have safety evaluations for at least three years after the last course of treatment. The companies anticipate filing for marketing approval of alemtuzumab for the treatment of MS in 2011.
About Multiple Sclerosis
Multiple sclerosis is a chronic disease of the central nervous system (CNS) in which the immune system can attack the brain and spinal cord. The disease causes a wide range of symptoms including fatigue, difficulty walking, numbness, and vision problems, and can progress to cause severe disability. Relapsing-remitting MS is the most common form of this disease.
Alemtuzumab is an investigational drug for the treatment of MS and must not be used outside of a formal clinical trial setting in MS patients. Physicians or patients seeking additional information about the CARE-MS I trial should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the U.S., +31 35 699 1499 in Europe, or visit www.clinicaltrials.gov.
Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Outside of the U.S., alemtuzumab has been approved for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product is marketed outside the United States as MabCampath® by Bayer Schering Pharma AG, Germany, and in the U.S. by the company's U.S. affiliate, Bayer HealthCare Pharmaceuticals, as Campath®.
Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body’s immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.
Genzyme and Bayer Schering Pharma AG, Germany, are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany, holds exclusive worldwide marketing and distribution rights to alemtuzumab.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
Genzyme®, Campath® and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved.
Genzyme’s press releases and other company information are available at www.genzyme.com.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.