November 4, 2014 /
Cambridge,
Mass. – Nov. 4, 2014 –
Genzyme, a Sanofi company, announced today enrollment of the first patient in a
multicenter Phase II clinical trial to evaluate Genzyme’s investigational
infusion therapy vatelizumab in patients with relapsing remitting multiple
sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy
of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and
pharmacokinetics of vatelizumab will also be assessed.
Mass. – Nov. 4, 2014 –
Genzyme, a Sanofi company, announced today enrollment of the first patient in a
multicenter Phase II clinical trial to evaluate Genzyme’s investigational
infusion therapy vatelizumab in patients with relapsing remitting multiple
sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy
of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and
pharmacokinetics of vatelizumab will also be assessed.
Multiple sclerosis is a chronic
inflammatory demyelinating and neurodegenerative disease of the central nervous
system (CNS). Uncontrolled
inflammation within the CNS leads to inflammatory damage that is associated
with demyelinating lesions and neurodegeneration in patients with MS.
Vatelizumab is a humanized monoclonal antibody that targets VLA-2, a
collagen-binding integrin expressed on activated lymphocytes. The mechanism of
action of vatelizumab is not known, although it is hypothesized to block VLA-2
on activated immune cells, leading to interference with collagen-binding in
areas of inflammation, and thus may reduce the inflammatory cascade in MS.
inflammatory demyelinating and neurodegenerative disease of the central nervous
system (CNS). Uncontrolled
inflammation within the CNS leads to inflammatory damage that is associated
with demyelinating lesions and neurodegeneration in patients with MS.
Vatelizumab is a humanized monoclonal antibody that targets VLA-2, a
collagen-binding integrin expressed on activated lymphocytes. The mechanism of
action of vatelizumab is not known, although it is hypothesized to block VLA-2
on activated immune cells, leading to interference with collagen-binding in
areas of inflammation, and thus may reduce the inflammatory cascade in MS.
“Continuous inflammation
and neurodegeneration from the onset of multiple sclerosis can lead to
significant disability,” said Eva Havrdova, MD, PhD, MS Center, Department of
Neurology, First Medical Faculty, Charles University, Prague. “The EMPIRE
trial should enable us to assess vatelizumab’s ability to impact the acute
inflammatory components of MS and evaluate its potential as an effective MS
treatment.”
and neurodegeneration from the onset of multiple sclerosis can lead to
significant disability,” said Eva Havrdova, MD, PhD, MS Center, Department of
Neurology, First Medical Faculty, Charles University, Prague. “The EMPIRE
trial should enable us to assess vatelizumab’s ability to impact the acute
inflammatory components of MS and evaluate its potential as an effective MS
treatment.”
Genzyme is developing
vatelizumab in MS in partnership with Glenmark Pharmaceuticals. In addition to
its marketed therapies, Genzyme has an MS R&D pipeline focused on
investigational treatments to address unmet needs for relapsing and progressive
forms of MS through research in selective immunomodulation, neuroprotection and
remyelination.
vatelizumab in MS in partnership with Glenmark Pharmaceuticals. In addition to
its marketed therapies, Genzyme has an MS R&D pipeline focused on
investigational treatments to address unmet needs for relapsing and progressive
forms of MS through research in selective immunomodulation, neuroprotection and
remyelination.
“We are
pleased to commence patient enrollment for our vatelizumab trial in relapsing
MS,” said David Meeker, President and CEO, Genzyme. “This milestone
demonstrates Genzyme’s long-term commitment to MS and aligns with our pipeline
strategy to focus on areas of unmet need.”
pleased to commence patient enrollment for our vatelizumab trial in relapsing
MS,” said David Meeker, President and CEO, Genzyme. “This milestone
demonstrates Genzyme’s long-term commitment to MS and aligns with our pipeline
strategy to focus on areas of unmet need.”
About EMPIRE
EMPIRE is a global phase
2a/2b double-blind, randomized, placebo-controlled study assessing the
efficacy, safety and dose-response of vatelizumab in patients with active
RRMS. The study duration is 12 weeks. The study is expected to
enroll 168 patients at 55 sites in 10 countries. For more information about the
vatelizumab trial, visit www.clinicaltrials.gov.
2a/2b double-blind, randomized, placebo-controlled study assessing the
efficacy, safety and dose-response of vatelizumab in patients with active
RRMS. The study duration is 12 weeks. The study is expected to
enroll 168 patients at 55 sites in 10 countries. For more information about the
vatelizumab trial, visit www.clinicaltrials.gov.
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.
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.
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).
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).
Genzyme®
is a registered trademark of Genzyme Corporation. All rights reserved.
is a registered trademark of Genzyme Corporation. All rights reserved.
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.
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.
Contact:
Genzyme Media Relations
Erin
Walsh
Walsh
+1
617-768-6881
617-768-6881
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