CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
new data from Genzyme’s clinical development programs for AUBAGIO®
(teriflunomide) and LEMTRADATM (alemtuzumab) will be
presented at the 28th Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France,
October 10-13.
“The data to be presented at ECTRIMS are a reflection not only of the
comprehensive clinical development programs supporting AUBAGIO and
LEMTRADA, but of the unique commitment and substantial progress Genzyme
has made to date in bringing forward differentiated therapies in
multiple sclerosis”
“The data to be presented at ECTRIMS are a reflection not only of the
comprehensive clinical development programs supporting AUBAGIO and
LEMTRADA, but of the unique commitment and substantial progress Genzyme
has made to date in bringing forward differentiated therapies in
multiple sclerosis,” said Genzyme CEO and President, David Meeker.
Once-daily, oral AUBAGIO is now commercially available in the U.S.
following FDA approval in patients with relapsing forms of MS. Marketing
applications for AUBAGIO and LEMTRADA are currently under review by the
EMA and other regulatory authorities.
Key data from across the company’s clinical development programs to be
presented are as follows. Abstracts are available on the ECTRIMS website.
TOWER (Teriflunomide Oral in people With
relapsing multiplE scleRosis)
TOWER is a randomized Phase III trial assessing once-daily oral AUBAGIO
(teriflunomide) in patients with relapsing multiple sclerosis. It is the
second Phase III study for AUBAGIO.
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The efficacy and safety of teriflunomide in patients with relapsing
MS: results from TOWER, a phase III, placebo-controlled study
(Parallel Session 12 – 153; October 12; 3:10 p.m. CEST, 9:10 a.m. EDT).
CARE-MS II (Comparison of Alemtuzumab and Rebif
Efficacy in Multiple Sclerosis II)
CARE-MS II was a randomized Phase III clinical trial designed to
evaluate whether the investigational MS therapy LEMTRADA (alemtuzumab)
could achieve meaningful efficacy and safety improvements over the
approved, active comparator Rebif (subcutaneous interferon beta-1a 44
mcg).
-
Efficacy of alemtuzumab in relapsing-remitting multiple sclerosis
patients who relapsed on prior therapy: subgroup analyses by previous
DMT use (Poster Session 1 – P483; October 11; 3:30 p.m. CEST, 9:30
a.m. EDT).
-
Disability improvement with alemtuzumab vs. interferon beta-1a in
relapsing-remitting multiple sclerosis patients who relapsed on prior
therapy (Poster Session 2 – P922; October 12; 3:30 p.m. CEST, 9:30
a.m. EDT).
-
Effect of alemtuzumab vs. Rebif® on brain MRI measurements: Results of
CARE-MS II (Poster Session 2 – P877; October 12; 3:30 p.m. CEST, 9:30
a.m. EDT).
-
Safety of alemtuzumab in relapsing-remitting multiple sclerosis
patients who relapsed on prior therapy (Poster Session 1 – P545;
October 11; 3:30 p.m. CEST, 9:30 a.m. EDT).
Additional Genzyme MS portfolio data, in addition to the Genzyme
satellite symposia to be featured at ECTRIMS include:
AUBAGIO:
-
Magnetic resonance imaging as a surrogate for clinical endpoints in
multiple sclerosis (Poster Session 2 – P1014; October 12; 3:30 p.m.
CEST, 9:30 a.m. EDT).
-
Teriflunomide treatment of human monocyte-derived dendritic cells in
vitro does not impair their maturation or ability to induce allogeneic
T-cell responses (Poster Session 2 – P950; October 12; 3:30 p.m. CEST,
9:30 a.m. EDT).
-
Effect of teriflunomide on immune responses to seasonal influenza
vaccination in patients with relapsing multiple sclerosis: results
from the TERIVA study (Poster Session 2 – P925; October 12; 3:30 p.m.
CEST, 9:30 a.m. EDT).
-
Effect of teriflunomide on the pharmacodynamic and pharmacokinetic
profiles of warfarin in healthy male subjects (Poster Session 1 –
P453; October 11; 3:30 p.m. CEST, 9:30 a.m. EDT).
-
Pregnancy outcomes from the teriflunomide clinical development
programme: retrospective analysis of the teriflunomide clinical trial
database (Poster Session 2 – P737; October 12; 3:30 p.m. CEST, 9:30
a.m. EDT).
-
Effect of teriflunomide on lymphocyte and neutrophil levels in
patients with relapsing multiple sclerosis: results from the TEMSO
study (Poster Session 2 – P995; October 12; 3:30 p.m. CEST, 9:30 a.m.
EDT).
LEMTRADA:
-
Autoimmunity in patients treated with alemtuzumab for
relapsing-remitting multiple sclerosis (Poster Session 2 – P1005;
October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
-
Lymphocyte subset dynamics following alemtuzumab treatment in the
CARE-MS I study (Poster Session 2 – P935; October 12; 3:30 p.m. CEST,
9:30 a.m. EDT).
-
Therapeutic treatment with an anti-mouse CD52 antibody reverses
disease symptoms in a murine EAE model of multiple sclerosis (Poster
Session 2 – P908; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
Satellite Symposium
“MS Pathophysiology and Implications for Treatment”
When: Thursday, October 11; 12:45 – 1:45 p.m. CEST
Location: Amphitheatre
About AUBAGIO® (teriflunomide)
The U.S. Food and Drug Administration (FDA) has approved AUBAGIO®
(teriflunomide) as a once-daily, oral immunomodulator indicated for
patients with relapsing forms of multiple sclerosis (MS). The ongoing
AUBAGIO clinical development program, involving more than 5,000 patients
in 36 countries, is among the largest of any MS therapy. Some patients
in extension trials have been treated up to 10 years.
AUBAGIO is an immunomodulator with anti-inflammatory properties.
Although the exact mechanism of action for AUBAGIO is not fully
understood, it may involve a reduction in the number of activated
lymphocytes in the central nervous system (CNS).
Click http://products.sanofi.us/aubagio/aubagio.pdf
for full Prescribing Information for once-daily oral AUBAGIO
(teriflunomide).
About Alemtuzumab/LEMTRADA™
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a
protein abundant on T and B cells. Treatment with alemtuzumab results in
the depletion of circulating T and B cells thought to be responsible for
the damaging inflammatory process in MS. Alemtuzumab has minimal impact
on other immune cells. The acute anti-inflammatory effect of alemtuzumab
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 alemtuzumab and has primary
responsibility for its development and commercialization in multiple
sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab
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).
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Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2011. Other than as required by applicable
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Genzyme® is a registered trademark. All rights reserved.
AUBAGIO® is a registered trademark. All rights reserved.
Rebif® is a registered trademark of EMD Serono, Inc. or
affiliates.