PARIS--(BUSINESS WIRE)--Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme
announced today positive top-line results from CARE-MS I, the first of
two randomized, Phase 3 clinical trials comparing the investigational
drug alemtuzumab to the approved multiple sclerosis therapy Rebif®
(high dose subcutaneous interferon beta-1a) in patients with
relapsing-remitting multiple sclerosis (RRMS). Genzyme is developing
alemtuzumab in MS in collaboration with Bayer HealthCare.
“We look forward to the
results from CARE-MS II, which will provide clinical data in patients
whose disease was not adequately controlled on other multiple sclerosis
therapies. Today’s results are an important step forward in the
development of alemtuzumab to address the substantial unmet needs for
multiple sclerosis patients.”
In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment
resulted in a 55 percent reduction in relapse rate compared to Rebif®
over the two years of the study (p<0.0001), hence satisfying the first
primary endpoint, and therefore meeting the predefined protocol criteria
for declaring the study a success. Statistical significance was not
achieved for the second primary endpoint, time to six month sustained
accumulation of disability, as compared to Rebif®. At the two year time
point, 8 percent of alemtuzumab treated patients had a sustained
increase in their Expanded Disability Status Scale (EDSS) score (or
worsening) as compared to 11 percent of those who received Rebif®
(Hazard Ratio=0.70, p=0.22). The patients will have the option to be
evaluated over the next 3 years as part of a separate protocol.
“The substantial effect of alemtuzumab on reduction of relapse rate
over and above that seen with Rebif® confirms our
experience gathered over many years and demonstrated in the Phase 2
study,” said Professor Alastair Compston, Chair of the Steering
Committee overseeing the conduct of the study, and head of the
Department of Clinical Neurosciences at the University of Cambridge,
United Kingdom. “We treated patients in CARE-MS I at a very early
stage in the course of their illness when the natural history may be
relatively quiet, and both groups were remarkably stable over the two
years of observation. Very few patients accumulated disability at the
rate expected from previous clinical trials, including our Phase 2
experience. Whilst welcome from the clinical perspective, this much
reduced our ability to detect a significant treatment effect on the
disability endpoint."
“In this 2-year comparative study, the effect of alemtuzumab on
reducing relapses versus Rebif, a leading drug for the treatment of
Multiple Sclerosis, is impressive, and the safety profile is consistent
with the Phase 2 clinical trial experience,” said Christopher A.
Viehbacher, Chief Executive Officer, Sanofi. “We look forward to the
results from CARE-MS II, which will provide clinical data in patients
whose disease was not adequately controlled on other multiple sclerosis
therapies. Today’s results are an important step forward in the
development of alemtuzumab to address the substantial unmet needs for
multiple sclerosis patients.”
The most common adverse events associated with alemtuzumab in the
CARE-MS I study included infusion-associated reactions, the symptoms of
which most commonly included headache, rash, fever, nausea, flushing,
hives and chills. The incidence of infections was also increased, the
most common infections involving the upper respiratory and urinary tract
and oral herpes. Infections were predominantly mild to moderate in
severity and there were no life-threatening or fatal infections.
No alemtuzumab patient discontinued from the study due to an adverse
event. Less than 20 percent of alemtuzumab-treated patients developed an
autoimmune thyroid-related adverse event and less than 1 percent
developed immune thrombocytopenia during the 2 year study period. There
were no cases of anti-GBM disease. Cases of autoimmunity were detected
and managed using conventional therapies. Patient monitoring for immune
cytopenias and thyroid or renal disorders is incorporated in all
Genzyme-sponsored trials of alemtuzumab for the investigational
treatment of MS. Analysis of the full CARE-MS I data is ongoing.
CARE-MS I, which enrolled 581 early, active RRMS patients who had
received no prior MS therapy, was a global, randomized, rater-blinded
clinical trial to determine the efficacy and safety of alemtuzumab in
this population. The company anticipates presenting detailed CARE-MS I
study findings at a medical meeting later this year.
Another Phase 3 clinical trial, CARE-MS II, is currently underway,
evaluating alemtuzumab against Rebif® in relapsing-remitting multiple
sclerosis patients who have relapsed while on therapy. Top-line results
from that trial are expected to be available in the fourth quarter of
2011. Since it is not yet approved for the treatment of MS, alemtuzumab
must not be used in MS patients outside of a formal, regulated clinical
trial setting in which appropriate patient monitoring measures are in
place.
The company expects to file for U.S. and E.U. approval of alemtuzumab in
MS in early 2012, and has been granted fast track designation by the FDA.
(*) Lemtrada™ is the registered name submitted to health authorities for
the investigational agent alemtuzumab.
About the CARE-MS I Trial
CARE-MS I (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple
Sclerosis, Study One) was a global, randomized, rater-blinded clinical
trial comparing two annual cycles of intravenous alemtuzumab, 12 mg/day
for 5 days initially and for 3 days a year later, to three-times weekly
subcutaneous interferon beta-1a (Rebif®) in treatment-naïve patients
with RRMS. The study enrolled 581 patients who had not previously
received treatment to suppress MS, except steroids. The study’s primary
outcome measures were reduction in relapse rate and time to sustained
accumulation of disability. Secondary outcome measures include:
Proportion of patients who are relapse-free at year two; Change from
baseline in Expanded Disability Status Scale; Acquisition of disability
as measured by change from baseline in Multiple Sclerosis Functional
Composite; and Percent change from baseline in magnetic*/ resonance
imaging (MRI)-T2 hyperintense lesion volume at year two. Additional
endpoints included the safety and tolerability of alemtuzumab.
About Alemtuzumab
Alemtuzumab is a humanized monoclonal antibody being studied as a
potential therapy for relapsing forms of multiple sclerosis. Alemtuzumab
targets the cell-surface glycoprotein CD52, which is highly expressed on
T- and B-lymphocytes. Preliminary research suggests that alemtuzumab
depletes the T- and B-cells that may be responsible for the cellular
damage in MS, while potentially sparing other cells of the immune
system. Early alemtuzumab research has also suggested a distinctive
pattern of lymphocyte repopulation following alemtuzumab treatment.
About the Alemtuzumab Development Partnership
Genzyme has the worldwide rights to alemtuzumab and has primary
responsibility for the development and commercialization of alemtuzumab
in multiple sclerosis (MS). Bayer HealthCare has been co-developing
alemtuzumab in MS with Genzyme. Bayer HealthCare retains an option to
co-promote alemtuzumab in MS and upon regulatory approval and
commercialization would receive contingent payments based on sales
revenue.
About Genzyme, a Sanofi Company
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 its founding in 1981, the company has introduced
breakthrough treatments that have provided new hope for patients in the
fields of rare inherited disorders, kidney disease, orthopaedics,
cancer, transplant, and immune diseases. Genzyme is a Sanofi company.
Genzyme’s press releases and other company information are available at www.genzyme.com.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi
has core strengths in the field of healthcare with seven growth
platforms: diabetes solutions, human vaccines, innovative drugs, rare
diseases, consumer healthcare, emerging markets and animal health.
Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer
HealthCare, a subgroup of Bayer AG with annual sales of more than EUR
16.913 billion (2010), 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, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare’s aim is to discover and manufacture
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55.700 employees and is represented
in more than 100 countries. Find more information at www.bayerhealthcare.com.
Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labeling and other
matters that could affect the availability or commercial potential of
such products candidates, the absence of guarantee that the products
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities as well as those
discussed or identified in the public filings with the SEC and the AMF
made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s
annual report on Form 20-F for the year ended December 31, 2010. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Genzyme® is a registered trademark and CARE-MS is a service mark of
Genzyme Corporation. All rights reserved. Rebif® is a registered
trademark of EMD Serono, Inc. or affiliates.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6788173&lang=en