Three-Year Analysis Demonstrates Robust, Highly Statistically Significant
Treatment Effect of Alemtuzumab Compared to Rebif(R)
CAMBRIDGE, Mass., Oct. 15 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) today announced that top-line, three-year data from a
completed Phase 2 clinical trial comparing alemtuzumab with Rebif(R)
(interferon beta- 1a) for the treatment of multiple sclerosis were
presented this weekend at the 23rd Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague. The
results come from an analysis conducted after 36 months of treatment for
334 patients in the three-year trial.
Results of the primary outcomes from this trial were presented by
Alastair Compston, professor of neurology and the head of the Department of
Clinical Neurosciences at the University of Cambridge, United Kingdom,
during the prestigious Charcot Award lecture at ECTRIMS.
Efficacy Results
Overall efficacy results demonstrate that alemtuzumab provides a
significant treatment effect that has been found to last three years among
patients in the study. Analysis of the first co-primary endpoint showed
that patients taking alemtuzumab experienced at least a 73 percent
reduction in the risk for relapse after three years of follow up when
compared to patients treated with interferon beta-1a. This difference was
highly statistically significant in favor of the alemtuzumab patients with
a p-value less than the pre-specified value (p=0.00396) assigned for the
three-year analysis.
Analysis of the other co-primary endpoint showed that patients taking
alemtuzumab experienced at least a 70 percent reduction in the risk for
progression of clinically significant disability when compared to patients
treated with interferon beta-1a. This difference was statistically
significant in favor of the alemtuzumab patients with a p-value less than
the pre-specified value (p=0.01646) assigned for the three-year analysis.
Results for the secondary endpoints support the findings seen in the
co- primary endpoints. Full, detailed efficacy and safety data from the
study are expected to be presented at the 60th Annual Meeting of the
American Academy of Neurology next spring.
"These results demonstrate the durability of the previously reported
effect of alemtuzumab for the treatment of multiple sclerosis that, by our
analysis, exceeds any current marketed products and anything that we can
see in development," said Richard A. Moscicki, MD, chief medical officer
for Genzyme. "We are very impressed with the consistency of these data and
feel that they continue to point to the strong likelihood of alemtuzumab
being approved for MS patients."
Safety Data: No New Cases of ITP
A total of six patients have been diagnosed with ITP associated with
Grade 3 or 4 thrombocytopenia in this trial and there have been no new
cases of ITP reported in the past year in this study.
Common non-serious adverse events included infusion reactions in the
alemtuzumab patients and flu-like symptoms in patients using interferon
beta- 1a. Severe infections were infrequent in the alemtuzumab patients and
were resolved with or without an intervention. The incidence of all thyroid
adverse events, including Graves' disease, was less than expected compared
to early reports in the literature on the use of alemtuzumab in MS.
Two Phase 3 studies have recently begun examining the safety and
efficacy of alemtuzumab for the treatment of multiple sclerosis. Genzyme
and Bayer Schering Pharma AG, Germany announced last month the start of the
CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple
Sclerosis), a randomized, rater-blinded study that will compare alemtuzumab
to Rebif(R) as first-line therapy for patients with relapsing-remitting
multiple sclerosis (MS). The second Phase 3 study, CARE-MS II, also has
begun and will enroll patients who have continued to experience relapse
episodes while on currently available disease-modifying therapies.
Phase 2 Trial Design
The phase 2 trial randomized 334 patients with active
relapsing-remitting multiple sclerosis at 49 medical centers in Europe and
the United States. Patients in the trial were treated with alemtuzumab at
one of two doses (12 or 24/mg per day intravenously for five days at
initial treatment, and three days of re-treatment after 12 months with an
option to treat again at 24 months), or interferon beta-1a (44 mcg
administered by subcutaneous injection three times per week, as indicated
in its product label).
The randomized trial compared the efficacy of alemtuzumab with
interferon beta-1a using two primary endpoints: the rate of relapse of MS
symptoms, and the time to Sustained Accumulation of Disability over six
months as measured by Expanded Disability Status Scale [EDSS]. Efficacy
assessments were made by independent neurologists blinded to therapy.
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
recently-initiated CARE-MS I Phase 3 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, debilitating disease in which the
immune system attacks the person's 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.
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.
Genzyme Hosts Investor Call This Morning
Genzyme will host an investor call with Professor Alastair Compston
this morning, Monday, October 15, from 8:30-9:30 a.m. EST. Three-year,
top-line data from the Phase 2 study will be presented and there will be
opportunity for investors to ask questions of the alemtuzumab investigator.
To participate in the call, please dial 1-888-889-4416 in the U.S. or
1-773-756-0616 outside of the U.S. The participant passcode is "Genzyme."
A replay of this call will be available by dialing 203-369-3276. This
call will also be available live on the investor events section of
http://www.genzyme.com. Replays of the call will be available until 9:29 p.m. on
October 22, 2007.
This press release contains forward-looking statements, including
statements about timelines for obtaining and presenting clinical trial
data, the expected efficacy of alemtuzumab in MS and its comparison to
current market products, the possibility of approval of alemtuzumab in MS,
and the continued enrollment of patients in related MS clinical trials.
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 actual results of the clinical trials demonstrate safety and
efficacy comparable to the 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 and Campath(R) and MabCampath(R) are registered trademarks of
Genzyme Corporation. 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.
Media Contact: Investor Contact:
Bo Piela Patrick Flanigan
(617) 768-6579 (617) 768-6563
SOURCE Genzyme Corporation
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http://www.clinicaltrials.gov
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CONTACT:
Media, Bo Piela, +1-617-768-6579, Investors,
Patrick Flanigan, +1-617-768-6563
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