CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
that 12 data presentations, including six platform presentations, from
the company’s multiple sclerosis (MS) clinical trial programs for
alemtuzumab and teriflunomide will be featured at the American
Academy of Neurology's (AAN) 64th Annual Meeting in New
Orleans, La., April 21-28. Presentations will include full data results
from CARE-MS II (The Comparison of alemtuzumab and Rebif®
Efficacy in Multiple Sclerosis), a Phase III trial investigating
alemtuzumab in MS patients who had relapsed while receiving prior MS
therapy, as well as new findings from the teriflunomide clinical
program, one of the largest and broadest of any MS therapy in
development.
“Genzyme’s robust development programs for alemtuzumab and
teriflunomide were designed to understand how these therapies can best
address significant unmet medical needs of people living with MS”
“Genzyme’s robust development programs for alemtuzumab and
teriflunomide were designed to understand how these therapies can best
address significant unmet medical needs of people living with MS,”
said David Meeker, M.D., President and CEO, Genzyme. “We are
committed to becoming a long-term partner to the MS community with the
goal of raising the expectation of what life with MS can be.”
Marketing applications for teriflunomide for the treatment of relapsing
forms of MS are under review by the U.S. Food & Drug Administration
(FDA) and European Medicines Agency (EMA). Genzyme is on track to submit
applications to the FDA and EMA for approval of alemtuzumab to treat
relapsing forms of MS in the second quarter of this year.
Following are selected scientific abstracts highlighting new results
from the Phase III CARE-MS II and CARE-MS I trials for alemtuzumab,
as well as the Phase III TEMSO (Study of Teriflunomide in
Reducing the Frequency of Relapses and Accumulation of Disability in
Patients With Multiple Sclerosis) trial for teriflunomide.
ALEMTUZUMAB CARE-MS II Platform Presentation:
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Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif
Efficacy in Multiple Sclerosis II (CARE−MS II): A Phase III Study in
Relapsing−Remitting Multiple Sclerosis Patients Who Relapsed on Prior
Therapy (Platform Presentation S01.004; April 24; 1:45 p.m. CT, 2:45
p.m. ET)
ALEMTUZUMAB CARE-MS I Platform Presentations:
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Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif
Efficacy in Multiple Sclerosis I (CARE−MS I): A Phase III Study in
Relapsing−Remitting Treatment−Naïve Patients (Platform Presentation
S01.006; April 24; 2:15 p.m. CT, 3:15 p.m. ET)
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Effect of Alemtuzumab vs. Rebif on Brain MRI Measurements: Results of
CARE−MS I, a Phase III Study (Platform Presentation S11.006; April 24;
4:15 p.m. CT, 5:15 p.m. ET)
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Incidence of Autoimmunity in a Phase III Trial: Comparison of
Alemtuzumab and Rebif in Multiple Sclerosis I (CARE−MS I) (Platform
Presentation S41.006; April 26; 2:15 p.m. CT, 3:15 p.m. ET)
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Infections in Phase III Study: Comparison of Alemtuzumab and Rebif
Efficacy in Multiple Sclerosis I (CARE−MS I) (Platform Presentation
S41.007; April 26; 2:30 p.m. CT, 3:30 p.m. ET)
TERIFLUNOMIDE TEMSO Platform Presentation:
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Effect of Teriflunomide on Relapses With Sequelae and Relapse Leading
to Hospitalization in a Population With Relapsing Forms of Multiple
Sclerosis: Results From the TEMSO Study (Platform Presentation
S30.003; April 25; 2:30 p.m. CT, 3:30 p.m. ET)
Additional Genzyme MS portfolio data to be presented include:
ALEMTUZUMAB:
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Relapse Outcomes With Alemtuzumab vs. Rebif in Treatment−Naïve
Relapsing−Remitting Multiple Sclerosis (CARE−MS I): Secondary and
Tertiary Endpoints (Poster Discussion PD5.004; April 25; 2:00 p.m. CT,
3:00 p.m. ET)
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Activity of an Anti−Murine CD52 Antibody in Experimental Autoimmune
Encephalomyelitis (Poster P05.117; April 25; 2:00 p.m. CT, 3:00 p.m.
ET)
TERIFLUNOMIDE:
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Effect of Repeated Doses of Teriflunomide on a Single Oral Dose of
Bupropion in Healthy Male Subjects (Poster P04.143; April 25; 7:30
a.m. CT, 8:30 a.m. ET)
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Teriflunomide Increases the Proportion of Patients Free From Disease
Activity in the TEMSO Phase III Study (Poster Discussion PD5.007;
April 25; 2:00 p.m. CT, 3:00 p.m. ET)
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Pregnancy Outcomes From the Teriflunomide Clinical Development
Program: Retrospective Analysis of a Global Pharmacovigilance Database
(Poster P06.190; April 26; 7:30 a.m. CT, 8:30 a.m. ET)
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Impact of Relapses With Sequelae on Disability, Health−Related Quality
of Life, and Fatigue in a Population With Relapsing Forms of Multiple
Sclerosis Using Data From TEMSO, a Pivotal Phase III Teriflunomide
Trial (Poster P07.082; April 26; 2:00 p.m. CT, 3:00 p.m. ET)
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Sanofi will host a conference call for the financial community
during the upcoming American Academy of Neurology Annual Meeting,
including the results of the CARE - MS II study.
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It will take place on Wednesday 25th April, 2012 at:
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15:00 Paris CEST / 14:00 London BST / 9:00 New York EDT
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The conference call will include a presentation followed by a Q&A
session.
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It will be accessible through audio webcast at www.sanofi.com
and via the following telephone numbers.
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CALL IN NUMBERS
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France +33 (0) 1 70 77 09 38
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UK +44 (0) 203 367 9457
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USA +1 866 907 5925
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AUDIO REPLAY
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An audio replay of the call will be available through the numbers
below.
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The replay will be available approximately 2 hours after the end of
the call.
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France +33 (0) 1 72 00 15 00
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UK +44 (0) 203 367 9460
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USA +1 877 642 3018
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Access code 276606#
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About 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. Although the exact mechanism
of effect in MS is unknown, this repopulation creates a re-balanced
immune system that potentially reduces MS disease activity.
In addition to the completed CARE-MS II study, another Phase III trial,
CARE-MS I, evaluated alemtuzumab against Rebif (interferon beta-1a) in
relapsing-remitting MS patients naive to prior treatment and found a
statistically significant reduction in relapse rate with alemtuzumab. In
both trials, alemtuzumab 12 mg was given as an IV administration on
eight days over the course of the two-year study. The first treatment
course of alemtuzumab 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.
Genzyme has the worldwide rights to alemtuzumab and has primary
responsibility for the development and commercialization in MS. Bayer
HealthCare has been co-developing alemtuzumab in MS with Genzyme. Bayer
HealthCare retains an option to co-promote alemtuzumab in MS and upon
regulatory approval and commercialization would receive contingent
payments based on sales revenue.
About Teriflunomide
Teriflunomide, a once daily oral tablet, is an immunomodulator with a
unique mechanism of action. Although the mechanism of action for
teriflunomide is not fully understood, research supports that
teriflunomide inhibits the proliferation of stimulated T and B
lymphocytes in the periphery thought to be responsible for the damaging
inflammatory process in MS, while generally maintaining normal immune
function. Teriflunomide selectively and reversibly inhibits DHODH, a key
enzyme in de novo pyrimidine synthesis required by rapidly dividing
lymphocytes. Through this effect, it limits the expansion of stimulated
T- and B-cells in the periphery and diminishes the numbers of activated
T- and B-cells available to migrate into the central nervous system
(CNS). Because the salvage pathway for pyrimidine synthesis is not
affected by teriflunomide, resting lymphocytes maintain their viability
and remain unaffected by teriflunomide.
Teriflunomide is being studied in a large clinical program that is
expected to include more than 5,000 trial participants in 36 countries.
Six efficacy clinical trials are either completed or underway with
teriflunomide, making the clinical program one of the largest of any MS
agent under development. In addition to the completed TEMSO and TENERE
trials, the Phase III, placebo-controlled trial TOWER was recently
completed in people with relapsing forms of MS. Another Phase III study,
TOPIC, is underway in early MS or CIS (clinically isolated syndrome).
Teriflunomide is also being evaluated as an adjunctive therapy to
interferon-β in the Phase III TERACLES trial. With up to 10 years of
continuous use in a Phase II extension, teriflunomide has the longest
clinical experience of any investigational oral MS therapy.
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).
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, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Genzyme® is a registered trademark. All rights reserved.
Rebif® is a registered trademark of EMD Serono, Inc. or
affiliates.