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
Therapies.
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.
About Alemtuzumab
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.
About Genzyme
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.)
508-410-0104 973-305-5258
SOURCE Genzyme
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Related links:
http://www.genzyme.com
http://www.bayerscheringpharma.de
http://www.clinicaltrials.gov
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Caroline De Bie (Europe), +32-472-719-746, or
Maria Cantor (U.S.), +1-508-410-0104, both of Genzyme; or Astrid
Kranz (Europe), +49-30-468-12057, or Kimberly Wix (U.S.),
+1-973-305-5258, both of Bayer Schering Pharma
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