Regeneron and Sanofi Announce Positive Dupixent® (dupilumab) Phase 3 Atopic Dermatitis Data Published in the New England Journal of Medicine

TARRYTOWN, N.Y. and PARIS, Oct. 1, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announce that detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating investigational Dupixent^® (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in the New England Journal of Medicine (NEJM). The studies met their primary endpoints evaluating the extent and severity of the disease. In addition, both trials met key secondary endpoints measuring reduction in itch, improvement in patient-reported anxiety and depression symptoms, and certain quality of life measures. Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in AD, and certain atopic or allergic diseases including asthma and nasal polyposis, where Dupixent is being evaluated in ongoing clinical studies.

"These results support the growing body of evidence for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease. The Phase 3 SOLO 1 and SOLO 2 clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated a significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures," said Eric Simpson, M.D., M.C.R., Oregon Health & Science University, and lead author of the NEJM paper. "Additionally, the reduction of itch intensity is important because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep."

The NEJM paper provides data on key endpoints including:

• At 16 weeks for SOLO 1 and SOLO 2, respectively, 37 and 36 percent of adult patients who received Dupixent 300 mg weekly, and 38 and 36 percent of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions as measured by the 5-point Investigator's Global Assessment (IGA) scale, compared to 10 and 8 percent with placebo (p less than 0.001). This was the primary endpoint of the study in the U.S. and one of the primary endpoints in the EU.
• At 16 weeks for SOLO 1 and SOLO 2, respectively, 52 and 48 percent of adult patients who received Dupixent 300 mg weekly, and 51 and 44 percent of patients who received Dupixent 300 mg every two weeks, achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) compared to 15 and 12 percent with placebo (p less than 0.001). This was the key secondary endpoint in the U.S. and one of the primary endpoints in the EU.
• At 16 weeks for SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received Dupixent 300 mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.001).
• The reduction in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was a secondary endpoint that was met at 2 weeks, 4 weeks and 16 weeks. The Pruritus NRS ranges from 0 (no itch) to 10 (worst itch imaginable). At 16 weeks, for SOLO 1 and SOLO 2, respectively, 40 and 39 percent of patients who received Dupixent 300 mg weekly and 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a four-point or greater reduction in their NRS score compared to 12 and 10 percent with placebo (p less than 0.001).

Other positive secondary endpoints discussed in the NEJM paper include improvement in patient-reported anxiety and depression symptoms and certain quality of life measures as evaluated by Scoring Atopic Dermatitis (SCORAD), Hospital Anxiety and Depression Scale (HADS), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).

For the 16-week treatment period, the overall rate of adverse events (65-73 percent Dupixent and 65-72 percent placebo) was comparable between the Dupixent groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for Dupixent and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for Dupixent and 5-6 percent for placebo. Serious or severe infections were similar in the Dupixent and placebo groups in both studies (1 percent Dupixent and 1 percent placebo). Adverse events that were noted to have a higher rate with Dupixent treatment across both studies included injection site reactions (8-19 percent Dupixent; 6 percent placebo) and conjunctivitis (1-5 percent Dupixent; 1 percent placebo). No patients discontinued therapy due to injection site reactions and one patient discontinued therapy due to conjunctivitis.

The Dupixent Biologics License Application (BLA) was recently accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) 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. In addition to AD, Dupixent is being evaluated in asthma, nasal polyposis and eosinophilic esophagitis. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

Regeneron and Sanofi will host an Investor Relations Thematic Conference Call for the financial community focusing on Dupixent following the late breaking data presentation at EADV at the following time: 7:00 a.m. ET (New York), 12:00 p.m. BST (London), 1:00 p.m. CEST (Paris and Vienna). To access this call, dial (888) 771-4371 (U.S.), 0805 102 604 (France), or 0808 238 9578 (UK). The conference call will include a presentation followed by a Q&A session and will be accessible through an audio webcast at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company's website.

About the LIBERTY AD SOLO 1 and SOLO 2 TRIALS

The Liberty AD Phase 3 clinical program consists of five trials of patients with moderate-to-severe atopic dermatitis (AD) at sites worldwide. A total of 1,379 adult patients with moderate-to-severe AD were enrolled in the identically designed SOLO 1 and SOLO 2 trials. Patients were enrolled if they were not adequately controlled with topical medications, or if topical treatment was not medically advisable. All patients were assessed via the 5-point Investigator's Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe); entry criteria required a baseline score of 3 or 4. Patients were also assessed using the Eczema Area and Severity Index (EASI) and other measures. Patients were randomized into one of three treatment groups: Dupixent 300 mg subcutaneously once per week, Dupixent 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial Dupixent loading dose of 600 mg subcutaneously, or placebo.

About Moderate-to-Severe Atopic Dermatitis

Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is characterized by rashes and can include intense itching, skin dryness, cracking, redness, crusting, and oozing. Even though atopic dermatitis symptoms appear on the skin, they are fueled by a continuous cycle of underlying inflammation triggered in part by a malfunction in the immune system. People living with the physical symptoms of atopic dermatitis may also feel self-conscious and embarrassed about their appearance and may experience anxiety, depression, and feelings of social isolation.

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 Merial. 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 based in Tarrytown, New York 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, asthma, atopic dermatitis, pain, oncology, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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SOURCE Regeneron Pharmaceuticals, Inc.

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