Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent® (dupilumab) in Moderate-to-Severe Atopic Dermatitis

Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent^® (dupilumab) in Moderate-to-Severe Atopic Dermatitis

            - Late-breaking oral abstract to be presented today at the Annual Meeting of the American Academy of Dermatology -

Paris, France and Tarrytown, N.Y. - March 4, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today presented detailed results from the one-year Phase 3 CHRONOS study, which showed that patients receiving the investigational drug Dupixent^® (dupilumab) with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled moderate-to-severe atopic dermatitis (AD). The data will be presented today as a late-breaking oral abstract at the Annual Meeting of the American Academy of Dermatology (AAD) taking place in Orlando, Florida.

"These new results build upon previous positive Phase 3 monotherapy data. In the CHRONOS study, Dupixent used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to  topical corticosteroids alone, which are commonly prescribed for moderate-to-severe atopic dermatitis," said Andrew Blauvelt, M.D., President of Oregon Medical Research Center and principal investigator of the study. "This study provides positive long-term data for Dupixent, which is important given atopic dermatitis is a chronic inflammatory disease. Additionally, the presentation highlights the critical role of IL-4 and IL-13 as drivers of this atopic condition."

Patients were eligible for participation in the CHRONOS study if their disease was uncontrolled by topical medicines including corticosteroids with or without calcineurin inhibitors. Patients were randomized to receive Dupixent 300 mg weekly with TCS, Dupixent 300 mg every two weeks with TCS, or placebo with TCS. Dupixent with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS.

As previously announced in June 2016, the primary endpoint results at week 16 and secondary endpoint 52-week results were the following:

• At 16 weeks, 39 percent of patients who received either Dupixent 300 mg weekly with TCS or Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 16 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 69 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 40 percent of patients who received Dupixent 300 mg weekly with TCS, and 36 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 65 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, compared to 22 percent with placebo with TCS (p less than 0.0001).

New data being presented at the meeting show that:

• At 16 weeks, the mean percent improvement in EASI from baseline was 77 percent for patients who received Dupixent weekly with TCS and for patients who received Dupixent every two weeks with TCS, compared to 42 percent for patients receiving placebo with TCS (p less than 0.0001).
• At 16 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was 55 percent for patients who received Dupixent weekly with TCS and 58 percent for patients who received Dupixent every two weeks with TCS, compared to 29 percent for patients receiving placebo with TCS (p less than 0.0001).
• At 16 weeks, 77 percent of patients who received Dupixent weekly with TCS or Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, compared to 37 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 16 weeks, 74 percent of patients who received Dupixent weekly with TCS and 81 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index (DLQI), compared to 43 percent of patients receiving placebo with TCS (p less than 0.0001). Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. 
• At 52 weeks, the mean percent improvement in EASI from baseline was 80 percent for patients who received DUPIXENT weekly with TCS and 78 percent for patients who received DUPIXENT every two weeks with TCS, compared to 46 percent for patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the NRS, was 54 percent for patients who received DUPIXENT weekly with TCS and 56 percent for patients who received DUPIXENT every two weeks with TCS, compared to 27 percent for patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 64 percent of patients who received Dupixent weekly with TCS and 76 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by POEM, compared to 26 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 63 percent of patients who received Dupixent weekly with TCS and 80 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement their quality of life, as measured by the DLQI, compared to 30 percent of patients receiving placebo with TCS (p less than 0.0001).

              
In the CHRONOS trial, 85 percent of patients who received Dupixent weekly with TCS and 86 percent of patients who received Dupixent every two weeks with TCS completed the 52 week treatment, compared to 67 percent of patients in the placebo group. Patients who received Dupixent with TCS had higher rates of injection site reactions (19 percent Dupixent weekly, 15 percent Dupixent every two weeks and 8 percent TCS alone) and cases of conjunctivitis (19percent Dupixent weekly,14 percent Dupixent every two weeks and 8 percent TCS alone).

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 AD in 2014. The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) on December 8, 2016.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, Dupixent 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 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 treatments that help 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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