– Aubagio(R) and Lemtrada(TM) Results To Be Highlighted –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 22, 2014--
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that 18 poster and oral presentations featuring Aubagio(R) (teriflunomide) and Lemtrada(TM) (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(R) (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(TM) (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.
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