CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
the publication of results from the LEMTRADA™
(alemtuzumab) CARE-MS I and CARE-MS II pivotal studies in patients with
relapsing-remitting multiple sclerosis (MS) in the November 1, 2012
online issue of The Lancet.
“Genzyme
set a new standard by comparing LEMTRADA exclusively to an approved
treatment in all of our studies. Publication of these findings by The
Lancet highlights the importance of these results to the MS
community.”
In CARE-MS I and CARE-MS II, LEMTRADA was significantly more effective
at reducing annualized relapse rates than the active comparator Rebif®
(high dose subcutaneous interferon beta-1a), and more patients on
LEMTRADA were relapse-free at two years. In addition, in CARE-MS II,
accumulation of disability was significantly slowed in patients given
LEMTRADA vs. Rebif. Further, patients treated with LEMTRADA were
significantly more likely to experience improvement in disability scores
than those treated with Rebif, suggesting a reversal of disability in
some patients.
“There is a tremendous unmet need for treatments that address the
progression of disability that people living with multiple sclerosis can
experience,” said Genzyme President and CEO, David Meeker, MD. “Genzyme
set a new standard by comparing LEMTRADA exclusively to an approved
treatment in all of our studies. Publication of these findings by The
Lancet highlights the importance of these results to the MS
community.”
CARE-MS I and CARE-MS II Efficacy Results
CARE-MS I and CARE-MS II (Comparison
of Alemtuzumab and Rebif®
Efficacy in Multiple
Sclerosis) are randomized Phase III
studies comparing the investigational treatment alemtuzumab to a
standard of care MS treatment, Rebif, in patients with
relapsing-remitting MS who were naïve to prior treatment or who had
relapsed while on prior therapy, respectively. The results from these
trials for LEMTRADA were superior to Rebif on clinical and imaging
endpoints, including a reduction in relapse rate and are published in
full in The Lancet.
“The observed efficacy in these and earlier clinical studies
indicates the potential, following regulatory approval, for
alemtuzumab to become a transformative therapy amongst the various MS
treatment options that are currently available,” said Professor
Alastair Compston, Chair of the Steering Committee overseeing the
conduct of the study, senior author of both manuscripts, and Professor
of Neurology, University of Cambridge, UK.
In both studies, LEMTRADA was significantly superior to Rebif in
reducing relapses. In CARE-MS I, 78 percent of patients treated with
LEMTRADA remained relapse-free for two years, providing statistically
significant improvement over Rebif (77.6 percent vs. 58.7 percent,
p<0.0001). In the CARE-MS II trial, 65 percent of patients treated with
LEMTRADA were relapse-free at two years, compared to 47 percent with
Rebif (p<0.0001). In addition, in CARE-MS II, LEMTRADA reduced relapse
rate to a greater extent than Rebif in all subgroups defined by previous
therapy, including: with or without any interferon therapy, and those
previously treated with Rebif or Copaxone® (glatiramer
acetate injection).
Study data also showed a strong clinical benefit by reducing the risk of
sustained accumulation of disability in patients taking LEMTRADA in
CARE-MS ll by 42 percent as compared with Rebif (p=0.008), with
significant improvement in disability scores that suggested a reversal
of pre-existing disability in some patients. In the trial, the mean
disability score for patients treated with LEMTRADA decreased over a
two-year period, indicating an improvement in their physical disability,
while the mean score for patients given Rebif increased, indicating a
worsening of disability (p<0.0001).
CARE-MS I and CARE-MS II Safety Results
Safety results were consistent across both studies. The most common
adverse events associated with LEMTRADA were infusion-associated
reactions, most commonly headache, rash, pyrexia, nausea and urticaria.
Infections were common in both groups. Infections more common on
LEMTRADA treatment included nasopharyngitis, upper respiratory, urinary
tract, herpes viral infections, sinusitis and influenza. Most
infusion-associated reactions and infections were mild to moderate in
severity and responded to standard treatments.
In both CARE-MS I and CARE-MS II, the incidence of serious adverse
events was similar between the two treatment arms. As previously
reported, autoimmune disorders were more common on patients treated with
LEMTRADA, primarily autoimmune thyroid disease. Approximately 1 percent
of LEMTRADA-treated patients in each study developed immune
thrombocytopenia (ITP) over the two year study period. There were no
cases of anti-GBM disease reported during the study period with one case
of glomerulonephritis during the follow-up period as has been previously
reported. The percentage of LEMTRADA-treated patients reported to have
malignant neoplasms was less than 1 percent. The overall safety profile
was similar for the LEMTRADA 12 mg and 24 mg groups.
In both trials, the autoimmune disorders were detected early through a
monitoring program and managed using conventional therapies. Patient
monitoring for autoimmune disorders is incorporated in all
Genzyme-sponsored trials of LEMTRADA for the investigational treatment
of multiple sclerosis.
Since it is not yet approved for the treatment of MS, LEMTRADA must not
be used in MS patients outside of a formal, regulated clinical trial
setting in which appropriate patient monitoring measures are in place.
About the CARE-MS Trials
The CARE-MS trials are Phase III, global, randomized clinical trials
designed to evaluate whether the investigational MS therapy LEMTRADA
could achieve meaningful efficacy and safety improvements over the
approved, active comparator Rebif (subcutaneous interferon beta-1a 44
mcg), a standard treatment for relapsing-remitting MS. The CARE-MS I
study evaluated 581 patients naïve to prior MS treatment, except for
steroids. The CARE-MS II study evaluated 840 patients who have had at
least one relapse occurring while on MS therapy, including standard
injectable disease modifying therapies.
In both trials, LEMTRADA was given as an IV administration a total of
eight times over the course of the two-year study. The first treatment
course of LEMTRADA was administered on five consecutive days, and the
second course was administered on three consecutive days 12 months
later. Rebif 44 mcg was administered by subcutaneous injection three
times per week, each week, throughout the two years of study.
About LEMTRADA™ (alemtuzumab)
LEMTRADA is a monoclonal antibody that selectively targets CD52, a
protein abundant on T and B cells. Treatment with LEMTRADA results in
the depletion of circulating T and B cells thought to be responsible for
the damaging inflammatory process in MS. LEMTRADA has minimal impact on
other immune cells. The acute anti-inflammatory effect of LEMTRADA is
immediately followed by the onset of a distinctive pattern of T and B
cell repopulation that continues over time, rebalancing the immune
system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to LEMTRADA and has primary
responsibility for its development and commercialization in multiple
sclerosis. Bayer HealthCare retains an option to co-promote LEMTRADA in
multiple sclerosis. Bayer HealthCare has notified Genzyme of its
intention to co-promote under this option. Upon regulatory approval and
commercialization, Bayer would receive contingent payments based on
sales revenue.
LEMTRADA™ is the proprietary name submitted to health authorities for
the company’s investigational multiple sclerosis agent alemtuzumab.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more 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,
consumer healthcare, emerging markets, animal health and the new
Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Genzyme® is a registered trademark. All
rights reserved.
Rebif® is a
registered trademark of EMD Serono, Inc. or affiliates.
Copaxone®
is a registered trademark of Teva Pharmaceutical Industries
Ltd.
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