Genzyme to Present Aubagio® (teriflunomide) and Lemtrada® (alemtuzumab) Data at CMSC

Genzyme, a Sanofi company, announced today that data on its relapsing multiple sclerosis treatments, Aubagio® (teriflunomide) and Lemtrada® (alemtuzumab), will be featured during the 2015 annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) being held in Indianapolis, Indiana, May 27-30.

“The data to be presented during CMSC provide further insight into the potential clinical impact of Aubagio and Lemtrada,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business. “For more than a decade, Genzyme has been dedicated to developing novel treatments for MS. In addition to the global launches of our two products, our early stage and clinical research programs in MS aim to address remaining unmet needs with innovative therapeutic approaches and underscore our long-term commitment to the MS community.”

Genzyme’s platform and poster presentations will feature efficacy and safety information on Aubagio and Lemtrada, while other company activities will explore the dynamics involved in treatment decisions. Presentation details along with information about Genzyme-sponsored activities are as follows.

Lemtrada:

• Durable Effect of Alemtuzumab on MRI Activity and Brain Atrophy in Relapsing-Remitting Multiple Sclerosis Patients: 4-Year Follow-up of Care-MS II (platform #3562)
• Alemtuzumab Improves Sustained Accumulation of Disability Outcomes Using the SAD-Plus Assessment in RRMS Patients with Inadequate Efficacy Response to Prior Therapy (poster #3531)
• Improvements in Quality of Life Are Maintained in Alemtuzumab-Treated RRMS Patients Who Develop Autoimmune Adverse Events: Care-MS II (poster #3560)
• Lymphocyte Pharmacodynamics and Safety of Natalizumab in Patients Previously Treated with Alemtuzumab (poster #3403)
• Infusion-Associated Reactions in Patients Receiving Alemtuzumab after Switching from Subcutaneous Interferon Beta-1a (poster #3543)

Aubagio:

• Teriflunomide Efficacy in Newly Diagnosed Patients With RMS Enrolled in the TEMSO and TOWER Studies: a Post Hoc Analysis (poster #3400)
• Consistent Efficacy of Teriflunomide in Prespecified Subgroup Analyses From a Phase 3 Trial (TOPIC) in Patients With Early Multiple Sclerosis (poster #3475)
• Efficacy and Safety of Teriflunomide in Patients Switching From Other Disease-Modifying Therapies (poster #3392)
• Hair Photography Project: Exploring the Clinical Course of Hair Thinning Associated With Teriflunomide (poster #3315)
• Baseline Characteristics of Patients Enrolled in the Teri-PRO Phase 4 Study in the United States vs Canada, Europe, and Latin America (poster #3389)
• Investigation of the Effectiveness and Tolerability of Colesevelam HCl for Accelerated Elimination of Teriflunomide in Healthy Subjects (poster #3517)

Disease Management:

• Best Practice Recommendations of Advanced Practice Clinicians for the Care of the Challenging MS Patient (poster #3657)

Genzyme-sponsored events at CMSC include the following:

Cases in MS: Selecting Appropriate Treatment Options for Patients
Date: Thursday, May 28 from 7 p.m. – 8 p.m.
Location: JW Marriott Indianapolis Grand Ballroom – Exhibit Hall, Product Theater Area

The Management of Infusions in Patients with Relapsing MS
Date: Friday, May 29, 7 a.m. – 8 a.m.
Location: JW Marriott Indianapolis – White River Ballroom G-J

In addition, Genzyme is a sponsor of the following symposium at CMSC being presented by the MS Association of America:

Addressing the Science and Emotion of Benefit and Risk: Working Collaboratively to Improve Shared Decision Making
Date: Thursday, May 28 from 8 p.m. – 9:15 p.m.
Location: JW Marriott Indianapolis – White River Ballroom C-D

Aubagio® (teriflunomide) U.S. Indication and Usage

Aubagio is a once-daily, oral therapy indicated in the U.S. for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally once-daily.

Important Safety Information About Aubagio for U.S. Patients

The Aubagio label includes the risk of hepatotoxicity and, teratogenicity (based on animal data). In the United States, this information can be found in the boxed warning.

In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. Serious events may include decreased white blood cell count, peripheral neuropathy, hyperkalemia, skin reactions and increased blood pressure. 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. ALT should be monitored monthly for at least 6 months in patients who start treatment with Aubagio.

Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception and in patients who are taking leflunomide. Aubagio is not recommended for breast feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia.

Please click here for full U.S. Prescribing Information for Aubagio, including boxed warning and contraindications.

About Aubagio® (teriflunomide)

Aubagio is approved in more than 50 countries, with additional marketing applications under review by regulatory authorities globally.

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). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries.

Lemtrada® (alemtuzumab) U.S. Indication and Usage

Lemtrada is indicated in the United States for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Lemtrada is contraindicated in patients who are infected with Human Immunodeficiency Virus (HIV) because Lemtrada causes prolonged reductions of CD4+ lymphocyte counts.

Important Safety Information About Lemtrada for U.S. Patients

Serious and life-threatening autoimmune conditions such as immune thrombocytopenia (ITP) and anti-glomerular basement membrane disease can occur in patients receiving Lemtrada. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals in patients who receive Lemtrada. Lemtrada is associated with serious and life-threatening infusion reactions. Lemtrada can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage anaphylaxis and serious infusion reactions. Lemtrada may be associated with an increased risk of malignancy, including thyroid cancer, melanoma and lymphoproliferative disorders. The Lemtrada REMS Program, a risk management program with frequent monitoring, has been implemented to help mitigate these serious risks.

The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada is contraindicated in patients with Human Immunodeficiency Virus (HIV) infection.

Please click here for full U.S. Prescribing Information for Lemtrada, including boxed warning and contraindications.

About Lemtrada® (alemtuzumab)

Lemtrada is approved in more than 40 countries, with additional marketing applications under review. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients worldwide and 5,400 patient-years of follow-up.

Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Although the exact mechanism of action for alemtuzumab is unknown, it is presumed to deplete circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes.

Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialization in multiple sclerosis. Bayer Healthcare receives contingent payments based on global sales revenue.

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.

Genzyme®, Aubagio® and Lemtrada® are registered trademarks of Genzyme Corporation. All rights reserved.

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).

Sanofi Forward-Looking Statements

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