- Aubagio® and Lemtrada™
Results To Be Highlighted -
Company Website:
http://www.genzyme.com
CAMBRIDGE, Mass. -- (Business Wire)
Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that 18
poster and oral presentations featuring Aubagio®
(teriflunomide) and LemtradaTM (alemtuzumab) will be
presented during the 66th American Academy of Neurology (AAN) Annual
Meeting to be held in Philadelphia, April 26 – May 3, 2014.
“As we continue to expand our global footprint in MS with product
launches planned in more than 30 countries this year, we are proud to
highlight the breadth and depth of our clinical development programs for
Aubagio and Lemtrada at AAN,” said David Meeker, President and CEO,
Genzyme. “These new data will help to build a deeper understanding of
MS and Genzyme’s treatments, and demonstrate our long-term commitment to
meeting the needs of people living with MS.”
Presentations on Aubagio and Lemtrada at AAN are as follows, along with
information about the Genzyme Corporate Therapeutic Update and Brain
Health Fair sponsorship.
Aubagio:
-
TOPIC: Efficacy and Safety of Once-Daily Oral Teriflunomide in
Patients with First Clinical Episode Consistent With Multiple
Sclerosis (Clinical Trials Plenary Session; May 2; 12:00 – 1:30 p.m.
EDT)
-
Teriflunomide Does Not Significantly Affect Primary and Memory
Antibody Responses to a Viral Antigen in Mice (Poster Session I –
P1.215; April 28; 3:00 p.m. EDT)
-
Teriflunomide Treatment Is Not Associated With Increased Risk of
Infections: Pooled Data From the Teriflunomide Development Program
(Poster Session II – P2.194; April 29; 7:30 a.m. EDT)
-
Pooled Safety Data From Four Placebo-Controlled Teriflunomide Studies
(Poster Session II – P2.203; April 29; 7:30 a.m. EDT)
-
Teriflunomide: Non-Clinical Evaluation Demonstrates No Effect On Sperm
DNA or Male Fertility (Poster Session II – P2.233; April 29; 7:30 a.m.
EDT)
-
Safety and Efficacy of Teriflunomide for up to 9 Years in Relapsing
Forms of Multiple Sclerosis: Update of the TEMSO Extension Trial
(Poster Session III – P3.150; April 29; 3:00 p.m. EDT)
-
Patients Free of Clinical MS Activity in TEMSO and TOWER: Pooled
Analyses of Two Phase 3 Placebo-Controlled Trials (Poster Session III
– P3.164; April 29; 3:00 p.m. EDT)
-
Updated Pregnancy Outcomes in Patients and Partners of Patients in the
Teriflunomide Clinical Trial Program (Poser Session IV – P4.161; April
30; 7:30 a.m. EDT)
-
Estimating the Onset of Efficacy With Teriflunomide in Patients With
Relapsing Forms of Multiple Sclerosis (Poster Session VII – P7.214;
May 1; 3:00 p.m. EDT)
Lemtrada:
-
Treatment with Anti-mouse CD52 Antibody Is Associated with
Preservation of Myelin and Maintenance of Axonal Conduction in the
MOG-induced EAE Mouse Model (Poster Session I – P1.220; April 28; 3:00
p.m. EDT)
-
Anti-murine CD52 Antibody Treatment Does Not Adversely Affect the
Migratory Ability of Immune Cells (Poster Session I – P1.222; April
28; 3:00 p.m. EDT)
-
Successful Detection and Management of Immune Thrombocytopenia in
Alemtuzumab-Treated Patients with Active Relapsing-Remitting Multiple
Sclerosis (Poster Session II – P2.198; April 29; 7:30 a.m. EDT)
-
Thyroid Autoimmune Adverse Events in Patients Treated with Alemtuzumab
for Relapsing-remitting Multiple Sclerosis: Four-year Follow-up of the
CARE-MS Studies (Poster Session II – P2.199; April 29; 7:30 a.m. EDT)
-
Safety of Using Disease-modifying Therapy Post-alemtuzumab Treatment
in Patients With Relapsing-remitting Multiple Sclerosis in the Core
and Extension Phases of CAMMS223, CARE-MS I, and CARE-MS II Studies
(Poster Session II – P2.201; April 29; 7:30 a.m. EDT)
-
Alemtuzumab Has Similar Efficacy and Safety in Active
Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Who Were
Treatment-Naive or Who Relapsed on Prior Therapy (Poster Session II –
P2.209; April 29; 7:30 a.m. EDT)
-
Alemtuzumab Improves Visual Outcomes vs. Subcutaneous Interferon
Beta-1a in Patients With Active Relapsing-Remitting Multiple Sclerosis
(RRMS) Who Relapsed on Prior Therapy: Analysis From the CARE-MS II
Study (Poster Session III – P3.158; April 29; 3:00 p.m. EDT; INS 7
Poster Rounds: Emerging Therapeutic Advances in Multiple Sclerosis –
I7-1.010; April 30; 4:30 p.m. EDT)
-
Sustained Improvement in Disability Outcomes with Alemtuzumab in
Active Relapsing-Remitting Multiple Sclerosis Patients Who
Participated in CARE-MS II: Three-year Follow-up (Poster Session III –
P3.165; April 29; 3:00 p.m. EDT)
-
Lymphocyte Counts Do Not Predict Risk of Subsequent Relapse or
Disability Accumulation in Alemtuzumab-Treated Relapsing-Remitting
Multiple Sclerosis Patients: An Analysis of the CARE-MS Studies
(Poster Session III – P3.181; April 29; 3:00 p.m. EDT)
Abstracts are available on the AAN website.
Genzyme Corporate Therapeutic Update
“The Evolving Paradigm: Individualizing MS Care”
When: Tuesday, April 29; 7:00 – 8:30 p.m. EDT
Location: Sheraton Philadelphia Downtown Hotel, Liberty Ballroom
(201 N 17th Street, Philadelphia)
Brain Health Fair
Genzyme is proud to serve as a silver sponsor of this year’s Brain
Health Fair, taking place on Saturday, April 26. The Brain Health Fair,
presented by the American Brain Foundation, the foundation of the
American Academy of Neurology, is a free event that is open to the
public and designed to help connect patients, families and caregivers
affected by neurologic disorders.
About Aubagio® (teriflunomide)
Aubagio is approved in the United States, European Union, Australia,
Argentina, Brazil, Canada, Chile, Columbia, Mexico, New Zealand, South
Korea and Switzerland, with additional marketing applications under
review by regulatory authorities globally.
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). Aubagio is supported by
one of the largest clinical programs of any MS therapy, with more than
5,000 trial participants in 36 countries. Some patients in extension
trials have been treated for up to 10 years.
About Lemtrada™ (alemtuzumab)
Lemtrada is approved in the European Union, Australia, Brazil, Canada
and Mexico. Lemtrada is currently not approved in the United States.
Following constructive discussions with the FDA, Genzyme plans to
resubmit in the second quarter of 2014 its application seeking U.S.
approval of Lemtrada. The resubmission will provide information to
specifically address issues previously noted by the FDA in its December
2013 Complete Response Letter. Marketing applications for Lemtrada are
also under review in other countries. Lemtrada is supported by a
comprehensive and extensive clinical development program that involved
nearly 1,500 patients and 5,400 patient-years of follow-up.
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 holds the right to co-promote alemtuzumab in
MS in the United States. Upon commercialization, Bayer will receive
contingent payments based on global sales revenue.
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.
Genzyme® and Aubagio® are registered trademarks
and LemtradaTM is a trademark of Genzyme Corporation.
About Sanofi
Sanofi, a global 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).
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 labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
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, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number
of shares outstanding 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, 2013. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Genzyme Media Relations
Erin Pascal, +1-617-768-6864
Erin.Pascal@genzyme.com
or
Sanofi
Investor Relations
Kristen Galfetti, +1-908-981-5560
ir@sanofi.com
Source: Genzyme
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