- Multiple Presentations Highlight Continuing Progress of AUBAGIO
and LEMTRADA Programs -
Genzyme,
a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced today that
data from its AUBAGIO® (teriflunomide) and LEMTRADATM
(alemtuzumab) multiple sclerosis clinical development programs will be
presented during the 65thAmerican Academy of Neurology
(AAN) Annual Meeting to be held in San Diego, Calif., March 16-23.
“We are proud to present these results that offer important new
insights into AUBAGIO and LEMTRADA,” said Genzyme CEO and President,
David Meeker, MD. “Our robust clinical development programs
underscore our steadfast commitment to advancing our understanding of
multiple sclerosis and its treatment, and to providing new hope for
people living with this devastating disease.”
Data from across the company’s clinical development programs to be
presented at AAN during Pacific Time are as follows, along with details
about the Genzyme Corporate Therapeutic Update and Brain Health Fair
sponsorship.
Platform Presentations for AUBAGIO and LEMTRADA:
AUBAGIO:
-
Pre-Defined Subgroups Analyses of TOWER, a Placebo‐Controlled Phase 3
Trial of Teriflunomide in Patients with Relapsing Multiple Sclerosis
(Platform Presentation Session 41 – S41.006; March 21; 1:30 p.m.)
-
Teriflunomide Efficacy and Safety in Patients with Relapsing Multiple
Sclerosis: Results From TOWER, a Second, Pivotal, Phase 3
Placebo‐Controlled Study (Platform Presentation Session 1 – S01.004;
March 19; 1:45 p.m.)
-
Pregnancy Outcomes From the Teriflunomide Clinical Development
Program: Retrospective Analysis of the Teriflunomide Clinical Trial
Database (Platform Presentation Session 30 – S30.005; March 20; 3:00
p.m.)
LEMTRADA:
-
Durable Efficacy of Alemtuzumab in Relapsing‐Remitting Multiple
Sclerosis Patients Who Participated in the CARE‐MS Studies: Three Year
Follow‐Up (Platform Presentation Session 41 – S41.001; March 21; 12:00
p.m.)
Additional Presentations:
AUBAGIO:
Poster Presentations
-
Immune Response to Seasonal Influenza Vaccination in Patients with
Relapsing Multiple Sclerosis Treated with Teriflunomide: the TERIVA
Study (Poster Session I – P01.169; March 18; 2:00 p.m.)
-
Frequency of Infections During Treatment with Teriflunomide: Pooled
Data From Three Placebo‐Controlled Teriflunomide Studies (Poster
Session I – P01.171; March 18; 2:00 p.m.)
-
Teriflunomide Reduces Relapse‐Related Sequelae, Hospitalizations and
Corticosteroid Use: A Post‐Hoc Analysis of the Phase 3 TOWER Study
(Poster Session VII – P07.109; March 21; 2:00 p.m.)
LEMTRADA:
Poster Presentations
-
Disability Improvement with Alemtuzumab vs. Interferon beta‐1a in
Relapsing-Remitting Multiple Sclerosis Patients Who Experienced
Disease Activity While on Prior Therapy (CARE‐MS II) (Poster Session
VII – P07.120; March 21; 2:00 p.m.)
-
Efficacy of Alemtuzumab vs IFNB‐1a in Relapsing‐Remitting Multiple
Sclerosis Patients Who Experienced Disease Activity While on Prior
Therapy (CARE‐MS II): Subgroup Analysis by Previous Disease Modifying
Therapy (DMT) Use (Poster Session VII – P07.111; March 21; 2:00 p.m.)
-
Alemtuzumab Reduces MS Disease Activity in Active Relapsing‐Remitting
Multiple Sclerosis Patients Who Had Disease Activity on Prior Therapy
(Poster Session VII – P07.093; March 21; 2:00 p.m.)
-
Adverse Event Profile of Alemtuzumab Over Time in Active
Relapsing‐Remitting Multiple Sclerosis Patients Who Experienced
Disease Activity While on Prior Therapy (CARE‐MS II) (Poster Session I
– P01.174; March 18; 2:00 p.m.)
-
Detection, Incidence, and Management of Thyroid Autoimmunity in
Comparison of Alemtuzumab and Rebif® in Multiple Sclerosis
(CARE‐MS I and II) (Poster Session I – P01.173; March 18; 2:00 p.m.)
-
Comparison of Infection Risk with Alemtuzumab and SC IFNB‐1a in
Patients with Multiple Sclerosis Who Experienced Disease Activity
While on Prior Therapy (CARE-MS II) (Poster Session I – P01.172; March
18; 2:00 p.m.)
-
Anti-IFNB-1a Antibody Status Was Not a Factor Influencing Efficacy of
Alemtuzumab vs IFNB-1a in Relapsing-Remitting Multiple Sclerosis
Patients Who Experienced Disease Activity While on Prior Therapy
(CARE-MS II) (Poster Session VII – P07.125; March 21; 2:00 p.m.)
-
Immunogenicity of Alemtuzumab Treatment in Relapsing‐Remitting
Multiple Sclerosis (RRMS) Patients in the CARE‐MS II Study (Poster
Session VII – P07.101; March 21; 2:00 p.m.)
-
Relapse Outcomes with Alemtuzumab vs IFNB‐1a in Active
Relapsing‐Remitting Multiple Sclerosis Patients Who Experienced
Disease Activity on Prior Therapy (CARE‐MS II) (Poster Session VII –
P07.098; March 21; 2:00 p.m.)
Abstracts are available on the AAN website.
Corporate Therapeutic Update
“Evolving
Standards in MS Care”
When: Tuesday, March 19; 7:00 –
10:00 p.m.
Location: Hilton San Diego Bayfront Hotel (1 Park
Boulevard, San Diego, CA)
Brain Health Fair
Genzyme is
proud to serve as a platinum sponsor of this year’s Brain Health Fair,
taking place on Saturday, March 16, 2013. 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. Genzyme has invited Children’s Hope
for Understanding Multiple Sclerosis (CHUMS) to host an interactive
exhibit, where visitors can experience what it’s like to have MS through
techniques that simulate common MS symptoms.
About LEMTRADA™ (alemtuzumab)
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.
LEMTRADATM is the proprietary name submitted to health
authorities for the company’s investigational multiple sclerosis agent
alemtuzumab.
About AUBAGIO®
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).
Indications and Usage
AUBAGIO (teriflunomide) is a once-daily, oral treatment indicated for
patients with relapsing forms of multiple sclerosis (MS). AUBAGIO 14 mg
has shown significant efficacy across key measures of MS disease
activity, including reducing relapses, slowing the progression of
physical disability, and reducing the number of brain lesions as
detected by MRI.
Important Safety Information About AUBAGIO
The AUBAGIO label includes a boxed warning citing the risk of
hepatotoxicity and, teratogenicity (based on animal data).
In MS clinical studies with AUBAGIO, the incidence of serious adverse
events were similar among AUBAGIO and placebo-treated patients. The most
common adverse events associated with AUBAGIO in MS patients included
increased ALT levels, alopecia, diarrhea, influenza, nausea and
paresthesia.
Teriflunomide is the principal active metabolite of leflunomide, which
is indicated in the U.S. for the treatment of rheumatoid arthritis.
Severe liver injury including fatal liver failure has been reported in
patients treated with leflunomide.
Leflunomide has an estimated 2.1 million patient years of exposure in
rheumatoid arthritis globally since its launch.
AUBAGIO is contraindicated in pregnant women and women of childbearing
potential who are not using reliable contraception.
AUBAGIO is supported by a robust clinical program with more than 5,000
trial participants in 36 countries and is amongst the largest of any MS
therapy. Some patients in extension trials have been treated for up to
10 years. The AUBAGIO approvals were based on efficacy data from the
TEMSO (TEriflunomide Multiple
Sclerosis Oral)
trial.
For full prescribing information and more information about AUBAGIO,
please visit www.genzyme.com.
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 the registered trademark of Genzyme Corporation.
All rights reserved.
AUBAGIO® is the registered trademark of Genzyme Corporation.
All rights reserved.
Rebif® is a registered trademark of EMD Serono, Inc. or
affiliates.
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 EUR 17.2 billion
(2011), 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, develop, manufacture and market
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and
is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
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