Sanofi and Regeneron to Present New Data on Dupixent® (dupilumab) for Moderate-to-Severe Atopic Dermatitis at Upcoming Medical Congresses

CAMBRIDGE, Mass. and TARRYTOWN, N.Y., Feb. 27, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced that detailed results from the Phase 3 CHRONOS study will be presented as a late-breaking abstract at this year's Annual Meeting of the American Academy of Dermatology (AAD). The CHRONOS study evaluated the use of investigational DUPIXENT for one year with topical corticosteroids versus topical corticosteroids alone for adults living with uncontrolled moderate-to-severe atopic dermatitis (AD). Additionally, interim safety and efficacy data will be presented from a Phase 3 long-term open-label study of DUPIXENT monotherapy for uncontrolled moderate-to-severe AD at the Annual Meeting of the American Academy of Asthma, Allergy, and Immunology (AAAAI).

Moderate-to-severe AD is a life-long chronic inflammatory disease. Despite currently available therapies, there still remains an unmet need for treatment to help those adults struggling to manage their moderate to severe AD.

Important company-supported presentations and posters include:

Annual Meeting of the American Academy of Dermatology (AAD) in Orlando, Fla., March 3 – 7, 2017

• Abstract #5267: Long-Term Management of Moderate-To-Severe Atopic Dermatitis (AD) with Dupilumab up to 1 Year with Concomitant Topical Corticosteroids (TCS): a Randomized, Placebo-Controlled Phase 3 Trial (CHRONOS)

Evaluation of efficacy and safety of long-term treatment with dupilumab plus concomitant topical corticosteroids in moderate-to-severe AD

Andrew Blauvelt, M.D., President of Oregon Medical Research Center, Portland, OR, USA

• Abstract #5279: Pharmacokinetics, Safety and Efficacy of Dupilumab in a Pediatric Population with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label Phase 2a Trial

Evaluation of the safety, efficacy and pharmacokinetics of dupilumab in pediatric patients with moderate-to-severe AD

Michael J. Cork, M.D., Professor of Dermatology, University of Sheffield, Sheffield, United Kingdom

• Abstract #5541: Real-World Disease Burden in U.S. Adults with Moderate-to-Severe Atopic Dermatitis Eligible for Treatment with Systemic Immunosuppressants

Analysis of immunosuppressant use among moderate-to-severe AD adult patients eligible for immunosuppressant therapy and to compare the real-world disease burden, including AD disease control, between patients treated with immunosuppressants and patients eligible for but not treated with immunosuppressants

April Armstrong, M.D., Associate Professor of Clinical Dermatology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA

• Abstract #5523: Real-World Utilization Patterns of Systemic Immunosuppressants among U.S. Adult Patients with Atopic Dermatitis

Analysis of real-world systemic immunosuppressant utilization patterns and adverse events in AD patients

April Armstrong, MD, Associate Professor of Clinical Dermatology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA

Annual Meeting of the American Academy of Asthma, Allergy, and Immunology (AAAAI) in Atlanta, Ga., March 3 – 6, 2017

• Abstract #L21: Long-Term Safety and Efficacy of Open-Label Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis

Evaluation of efficacy and safety of long-term treatment with dupilumab in adults with uncontrolled moderate-to-severe AD

Prof. Mette Deleuran, Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

The DUPIXENT Biologics License Application (BLA) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 29, 2017. The FDA granted DUPIXENT Breakthrough Therapy designation in uncontrolled moderate-to-severe atopic dermatitis in 2014. The European Medicines Agency (EMA) and FDA have conditionally accepted DUPIXENT as the trade name for dupilumab.

DUPIXENT is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, dupilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

About Atopic Dermatitis
AD is the most common form of eczema and is characterized by unpredictable flare-ups. It is a chronic inflammatory disease with symptoms often appearing on the skin. Moderate-to-severe AD is characterized by rashes and can include intense, persistent and debilitating itching, skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.

It's estimated that approximately 300,000 people in the United States are living with uncontrolled moderate-to-severe AD and despite their current treatment, are most in need of new treatment options. Despite currently available therapies, there still remains an unmet need for treatment that helps those adults struggling to manage their moderate-to-severe AD.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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