- Depth of Research, Including Pivotal Phase III Data for LemtradaTM*
and AubagioTM*, Underscores
Genzyme’s Commitment to Patients with Multiple Sclerosis -
PARIS--(BUSINESS WIRE)--Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme
announced today that more than 20 data presentations from the company’s
growing multiple sclerosis (MS) portfolio will be showcased at the 5th
Joint Triennial Congress of the European and Americas Committees for
Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS 2011).
Data to be presented will include new results from pivotal Phase III
clinical trials of the company’s lead investigational candidates for the
treatment of relapsing MS, LemtradaTM (alemtuzumab) and
AubagioTM (oral teriflunomide), and will be featured in
platform and poster presentations.
“With Lemtrada TM
and Aubagio TM – two unique, promising
investigational treatments – we hope to deliver advancement in MS
treatment across the patient spectrum.”
“Genzyme is committed to transforming the landscape of MS treatment
through novel research and development aimed at addressing significant
unmet needs for patients with MS,” said David Meeker, M.D., Chief
Operating Officer, Genzyme. “With Lemtrada TM
and Aubagio TM – two unique, promising
investigational treatments – we hope to deliver advancement in MS
treatment across the patient spectrum.”
Following are select abstracts highlighting new data from the Phase III
CARE-MS I study (The Comparison of Alemtuzumab and Rebif®
Efficacy in Multiple Sclerosis) and the Phase III TEMSO trial (Study of
Teriflunomide in Reducing the Frequency of Relapses and Accumulation of
Disability in Patients With Multiple Sclerosis). Note that data is
embargoed until the date and time of the presentation:
Late-Breaker Oral Presentation for Lemtrada TM:
-
Efficacy and Safety Results from CARE-MS I: A Phase III Study
Comparing Alemtuzumab and Interferon Beta-1a (Late-Breaker Oral
Presentation 151; 22 October, 09:15-09:30 CEST)
Expanded TEMSO Results for Aubagio TM:
-
Extension of a Phase III Trial (TEMSO) of Oral Teriflunomide in
Multiple Sclerosis with Relapses: Clinical and MRI Data 5 Years After
Initial Randomization (Poster 924; 21 October, 15:30-17:00 CEST)
-
Efficacy of Oral Teriflunomide in Multiple Sclerosis with Relapses:
Cognitive Outcomes from a Phase III Trial (TEMSO) (Poster 438; 20
October, 15:30-17:00 CEST)
-
Extension of a Phase III Trial (TEMSO) of Oral Teriflunomide in
Multiple Sclerosis with Relapses: Safety Outcomes with Up to 4 Years
of Follow-Up (Poster 439; 20 October, 15:30-17:00 CEST)
-
Effect of Teriflunomide on Relapses Leading to Healthcare Resource
Use: Results from the TEMSO Study (Poster 250; 20 October, 15:30-17:00
CEST)
Following are additional, select abstracts from the Genzyme MS pipeline
program:
LemtradaTM:
-
Alemtuzumab for Multiple Sclerosis in Patients Who Have Relapsed on
Therapy: CARE-MS II Baseline Demographics and Disease Characteristics
(Poster 928; 21 October, 15:30-17:00 CEST)
-
Leukocyte Dynamics Following Alemtuzumab Treatment of
Relapsing-Remitting Multiple Sclerosis: Long-term Follow-Up of
CAMMS223 Patients (Poster 437; 20 October, 15:30-17:00 CEST)
-
Alemtuzumab’s Durable Efficacy in Multiple Sclerosis Four Years after
Last Treatment Cycle (Poster 931; 21 October; 15:30-17:00 CEST)
-
Analysis of Innate Immune Competence Following Alemtuzumab Treatment
in Human CD52 Transgenic Mice (Poster 791; 21 October, 15:30-17:00
CEST)
AubagioTM:
-
Long-term Safety and Tolerability of Teriflunomide in Multiple
Sclerosis: 9-Year Follow-Up of a Phase II Study (Poster 914; 21
October, 15:30-17:00 CEST)
-
Efficacy of Teriflunomide in Relapsing Multiple Sclerosis: Phase II
Extension Study with 8-Year Follow-Up (Poster 440; 20 October,
15:30-17:00 CEST)
*LemtradaTM and AubagioTM are the proprietary
names submitted to health authorities for the company’s investigational
multiple sclerosis agent alemtuzumab and teriflunomide respectively.
About LemtradaTM (alemtuzumab)
Lemtrada is a humanized monoclonal antibody being studied as a potential
therapy for relapsing MS. Lemtrada targets the cell-surface glycoprotein
CD52, which is highly expressed on T- and B-lymphocytes. Preliminary
research suggests that Lemtrada initially depletes the T- and B-cells
that may be responsible for the cellular damage in MS. This depletion of
T- and B-cells is followed by a distinctive pattern of lymphocyte
repopulation. Lemtrada appears to have little or no effect on other
cells of the immune system. In addition to the completed CARE-MS I
study, another Phase III trial, CARE-MS II, will evaluate Lemtrada
against interferon beta-1a in relapsing-remitting multiple sclerosis
patients who have relapsed while on therapy, with top-line results
expected to be available in the fourth quarter of 2011.
About AubagioTM (teriflunomide)
Teriflunomide is an immunomodulatory, disease-modifying oral drug with
anti-inflammatory properties, and is under investigation for the
treatment of relapsing forms of MS. Teriflunomide blocks the
proliferation and functioning of activated T and B lymphocytes – which
are thought to be especially damaging in MS – by selectively and
reversibly inhibiting a critical mitochondrial enzyme. With nine years
of continuous use in a Phase II extension, teriflunomide has the longest
clinical experience of any investigational oral MS therapy. In addition
to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are
ongoing in people with relapsing MS. A Phase III study, TOPIC, is also
underway in early MS or CIS (clinically isolated syndrome).
Teriflunomide is also being evaluated as an adjunct therapy to
interferon-β in the Phase III TERACLES trial.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated
to making a major positive impact on the lives of people with serious
diseases. Since its founding in 1981, the company has introduced
breakthrough treatments that have provided new hope for patients. The
company’s areas of focus are rare genetic diseases, multiple sclerosis,
cardiovascular disease, and endocrinology. Genzyme is a Sanofi company.
Genzyme’s press releases and other company information are available at www.genzyme.com.
Genzyme is responsible for the development of teriflunomide and
alemtuzumab.
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, rare
diseases, consumer healthcare, emerging markets and animal health.
Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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