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Genzyme Announces Enrollment of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis05-11-2014
Cambridge, Mass. - Nov. 4, 2014 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), 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.

“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.”

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.

“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.”

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.

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 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.

Genzyme® 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.

Contact:
Genzyme Media Relations
Erin Walsh
+1 617-768-6881
erin.walsh@genzyme.com
Genzyme Corporate


24-11-2014 - European CHMP Adopts Positive Opinion for Genzyme’s Cerdelga® (eliglustat) Capsules
05-11-2014 - Genzyme Announces Enrollment of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis
22-08-2014 - FDA Approves Genzyme’s Cerdelga (eliglustat) Capsules - Only First-Line Oral Treatment for Adult Gaucher Disease Type 1
28-05-2014 - Genzyme Recognizes Sixth Annual World MS Day
12-12-2013 - FDA Grants Priority Review for Genzyme’s Cerdelga™ (eliglustat), an Investigational Oral Therapy for Gaucher Disease - - Second Major Regulatory Filing Following EMA Acceptance in Late October -
15-11-2013 - To nye MS-medikamenter lanseres i Norge
19-09-2013 - Europeiske legemiddelmyndigheter/EU-kommisjonen godkjenner Lemtrada™ (alemtuzumab), medikament for behandling av multippel sklerose
03-09-2013 - Europeiske legemiddelmyndigheter/EU kommisjonen godkjenner Aubagio® (teriflunomide), en gang daglig, oral behandling for pasienter med MS
28-06-2013 - Genzyme Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe
29-05-2013 - Genzyme Celebrates Fifth Annual World MS Day
25-04-2013 - Once-daily AUBAGIO® Delayed Onset of Clinically Definite Multiple Sclerosis (MS) in TOPIC Study
22-03-2013 - Effect of Genzyme’s LEMTRADA Maintained in Patients Beyond Two-Year Pivotal MS Studies
13-03-2013 - Multiple Presentations Highlight Continuing Progress of AUBAGIO and LEMTRADA Programs
27-02-2013 - Genzyme Receives Company Award from European Organisation for Rare Diseases (EURORDIS)
26-02-2013 - Genzyme Recognizes International Rare Disease Day with Global Awareness Programs and Launch of Third Annual Patient Advocacy Leadership (PAL) Awards
21-02-2013 - Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease
01-11-2012 - Genzyme Announces Publication of LEMTRADA (alemtuzumab) Pivotal Studies in The Lancet.
09-10-2012 - Genzyme to Present New Data from AUBAGIO® and LEMTRADATM Clinical Development Programs at ECTRIMS
17-09-2012 - FDA Approves Genzyme’s AUBAGIO® (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Multiple Sclerosis
28-02-2011 - International Rare Disease Day
16-02-2011 - Sanofi-aventis to Acquire Genzyme
13-10-2010 - Genzyme’s Alemtuzumab Shows Sustained Reduction in Relapses and Disability in Five-Year Review of MS Patients from Phase 2 Trial


 

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