CAMBRIDGE, Mass. and BERLIN /PRNewswire-FirstCall/ -- Genzyme Corporation and Bayer Schering Pharma AG, Germany announce that important, new clinical data will be presented this weekend from two studies regarding alemtuzumab use in patients with multiple sclerosis (MS) at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) underway in Prague.
Charcot Award Lecture
Top-line, three-year data from a completed international, multi-center, Phase 2 clinical trial known as CAMMS223 that compared alemtuzumab with Rebif(R) (interferon beta-1a) for the treatment of multiple sclerosis will be presented on Sunday, Oct. 14 at 10 a.m. The data will be presented by Professor Alastair Compston during the prestigious Charcot Award lecture. The study results, taken at 36 months, compare alemtuzumab-treated patients with Rebif(R)-treated patients in the risk for sustained accumulation of disability and the risk for relapse. The data come from a pre-specified analysis conducted after three years of treatment for 334 patients in the study.
Details on two poster presentations
-- Alemtuzumab Improved Multiple Sclerosis Functional Composite Scores and
Delayed Time to First Relapse at 2-Year Interim Analysis Compared to
Subcutaneous Interferon Beta 1-a.
Sat. October 13 from 3:30-5:00 p.m. Alasdair J. Coles, M.D.
A further analysis of disability in CAMMS223, as measured by the Multiple Sclerosis Functional Composite Scale (MSFC), will be reported at ECTRIMS. Data from this scale, including quantitative tests on ambulation, manual dexterity, and cognition, will be presented along with new analyses of relapse events. These results build on the two-year analyses of the co-primary endpoints presented at the American Academy of Neurology annual meeting in May, 2007, which demonstrated that the risk of sustained accumulation of disability as well as the annualized relapse rate were markedly reduced in alemtuzumab-treated patients compared to Rebif-treated patients. Data from CAMMS223 provide the rationale for the newly initiated Phase 3 CARE-MS I clinical trial in untreated patients with relapsing-remitting multiple sclerosis.
-- Two-year Results with Alemtuzumab in Patients with Active Relapsing-
Remitting Multiple Sclerosis Who Have Failed Licensed Beta-Interferon
Saturday, October 13 from 3:30-5:00 p.m. Ed Fox, M.D.
In another poster presentation, data from an investigator-sponsored study demonstrate the benefits of alemtuzumab in previously treated MS patients. Data from this two-year study evaluate the effect of two annual cycles of alemtuzumab on patients with relapsing-remitting MS who had failed prior treatment with licensed beta-interferons. Reported at ECTRIMS will be new data on patient functioning as measured by the Multiple Sclerosis Functional Composite Scale cited above. Data from this study provides the basis for the second Phase 3 clinical trial, CARE-MS II, in patients who have continued to relapse while using a licensed therapy. This study is also open to enrollment.
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.
Alemtuzumab is an investigational drug for the treatment of MS and must not be used in MS patients outside of a formal clinical trial setting. Physicians or patients seeking additional information about the CARE-MS trials should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the United States, + 31 35 6991499 in Europe, or visit http://www.clinicaltrials.gov.
About Multiple Sclerosis
Multiple Sclerosis (MS) 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.
According to the National Multiple Sclerosis Society, approximately 400,000 Americans acknowledge having MS, and every week about 200 people are diagnosed. Worldwide, multiple sclerosis may affect 2.5 million individuals.
Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath(R).
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.
Campath has a boxed warning which includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions in patients with B-CLL were infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.
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.
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 AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://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 http://www.bayerscheringpharma.de.
Genzyme(R), Campath(R), and MabCampath(R) are registered trademarks of Genzyme Corporation. All rights reserved. Rebif(R) is a registered trademark of EMD Serono, Inc.
Genzyme's press releases and other company information are available at http://www.genzyme.com and by calling Genzyme's investor information line at 1-800- 905-4369 within the United States or 1-703-797-1866 outside the United States.
Genzyme: Bayer Schering Pharma:
Caroline De Bie (Europe) Astrid Kranz (Europe)
+32 472 719 746 +49 30 468 12057
Maria Cantor (U.S.) Kimberly Wix (U.S.)
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