CAMBRIDGE, Mass., and BERLIN, Sept. 26 /PRNewswire-FirstCall/ --
Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany
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 I trial (Comparison of Alemtuzumab and Rebif Efficacy in
Multiple Sclerosis), a randomized, rater-blinded study, will compare
alemtuzumab to Rebif(R) (interferon beta-1a) in patients with relapsing-
remitting multiple sclerosis (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 who 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 compared with Rebif-treated patients in
the risk for sustained accumulation of disability and the risk for relapse
for 24 months. 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, 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 from their entry into the trial until 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.
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 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.
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.
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.
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 .
Forward-Looking Statements
This press release contains forward-looking statements, including
statements about the initiation of clinical trials, regulatory plans and
expected timelines for alemtuzumab, including the initiation of a second
Phase 3 trial in MS patients and the timing thereof, the timing of
obtaining clinical trial data, enrollment in clinical trials and the
ability to manage patient safety. These statements are subject to risks and
uncertainties that could cause actual results to differ materially from
those projected in these forward-looking statements. These risks and
uncertainties include, among others: that final results of the clinical
trial demonstrate safety and efficacy comparable to the interim data that
have emerged to date, the actual timing and content of submissions to and
decisions made by the regulatory authorities, institutional review boards,
data safety monitoring boards and treating physicians regarding the
continued administration of alemtuzumab to MS patients, Genzyme's ability
to develop and obtain approval of a patient safety plan, and the other
risks and uncertainties described in reports filed by Genzyme with the
Securities and Exchange Commission under the Securities Exchange Act of
1934, as amended, including without limitation the information under the
heading "Risk Factors" in the Management's Discussion and Analysis of
Financial Condition and Results of Operations section of the Genzyme
Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. Genzyme
cautions investors not to place substantial reliance on the forward-looking
statements contained in this press release. These statements speak only as
of the date of this press release, and Genzyme undertakes no obligation to
update or revise the statements
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 1-678-999-4572 outside the
United States.
Bayer Schering Pharma AG, Germany press releases and other information
are available at pharma.bayer.com or by calling 1-888-84BAYER.
Genzyme Contacts: Bayer Schering Pharma AG, Germany Contacts:
Dan Quinn (media) Jost Reinhard (ex-U.S.)
(617) 768-6849 +49 30 468 15062
Patrick Flanigan (investors) Kim Wix (U.S.)
(617) 768-6563 (973) 305-5258
SOURCE Genzyme Corporation; Bayer Schering Pharma AG
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Related links:
http://www.clinicaltrials.gov
http://www.bayerhealthcare.com
http://www.bayerscheringpharma.de http://www.genzyme.com/
http://www.prnewswire.com/comp/104284.html/
CONTACT:
media, Dan Quinn, +1-617-768-6849, investors,
Patrick Flanigan, +1-617-768-6563, both of Genzyme, or Jost
Reinhard (ex-U.S.), +49 30 468 15062, or Kim Wix (U.S.),
+1-973-305-5258, both of Bayer Schering Pharma AG, Germany
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