|Cambridge, Mass. – May 29, 2013 – Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), together with the global multiple sclerosis (MS) community of patients, advocates and healthcare providers, will today celebrate World MS Day, a campaign created by the Multiple Sclerosis International Federation (MSIF) to raise awareness of MS. Genzyme is committed to making a difference in the lives of people living with MS with differentiated therapies that include once-daily, oral AUBAGIO® and LEMTRADA™, as well as a research pipeline focused on innovative approaches to treating MS. LEMTRADA (alemtuzumab) is currently under regulatory review. |
As proud supporter of World MS Day and other MSIF programs, Genzyme has diversified its franchise offering with innovative grants and partnerships designed to broaden awareness about MS and address remaining unmet needs within the community. 2013 grants and partnerships include:
The International Progressive MS Collaborative: Genzyme is an active supporter for this global platform, developed to leverage the unique expertise and resources of its experts to expedite the development of effective disease modifying and symptom management therapies for progressive forms of MS.
MSIF Infrastructure Grant: Genzyme has provided a grant to the MSIF that will initiate, support and encourage the development of new MS organizations in Middle East and Pan-Asia regions, where there is currently little support, limited information and low awareness of the disease. MSIF has already begun to see the emergence of patient-led organizations and Genzyme’s support will help strengthen the MSIF’s ability to meet the needs of people with MS in these regions.
I Ride with MS: Genzyme is the sole sponsor of the I Ride with MS program from the National Multiple Sclerosis Society that celebrates cyclists participating in the Society’s annual Bike MS series who are also living with MS. By providing visibility to riders living with MS, “I Ride with MS” participants are not only strengthening cyclists commitment to create a world free of MS, but also serve to inspire all who are part of the MS movement. Bike MS consists of 100 cycling events across the country that aim to raise money for MS research and other services supported by the Society.
MS One to One™: Because each patient’s experience with MS is unique, Genzyme has also created MS One to One to provide customized, one-to-one support with a dedicated, MS certified team of nurses available 24/7, offer information and answers to frequently asked questions about MS, and more. For more information, visit www.MSOnetoOne.com.
“Today and every day, millions of people living with MS and their families will face challenges with incredible strength and determination,” said Bill Sibold, SVP and Head of MS, Genzyme. “While MS can be a devastating diagnosis, there has never been a more hopeful time than now with new and exciting treatment advances. As a supporter of World MS Day, our MS team at Genzyme is inspired by those living with MS. We are proud to participate in this year’s campaign and are committed to engaging the global community across the spectrum of care. Our pledge to the community is that we will take on the challenge of MS together.”
In its fifth year, World MS Day 2013 carries the theme of “What’s Your Motto,” collecting inspirational phrases around three areas most important to young adults living with MS: identity, relationships and the future. To get the conversation started, MSIF identified six young adults around the world to share their mottos on www.WorldMSDay.org.
Genzyme and its local affiliates are supporting a wide range of activities in recognition of World MS Day. Across the globe, Genzyme employees have also joined the MSIF “What’s Your Motto” international campaign by artistically depicting their own mottos through paintings, photography and video.
About LEMTRADA™ (alemtuzumab)
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. The depletion of circulating T and B cells is 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.
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.
Sanofi, an integrated 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).
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