Positive Dupixent® (dupilumab) data across five diseases with underlying type 2 inflammation to be presented at 2022 AAAAI Annual Meeting

February 1, 2022

Positive Dupixent^® (dupilumab) data across five diseases with underlying type 2 inflammation to be presented at 2022 AAAAI Annual Meeting

Late-breaking pivotal data show significant disease improvements in eosinophilic esophagitis and also in chronic spontaneous urticaria
18 abstracts add to body of evidence that IL-4 and IL-13 pathways inhibited by Dupixent are key drivers of the type 2 inflammation underlying certain diseases, accounting for the impact of Dupixent in its approved and investigational indications
Data support the well-established safety profile of Dupixent

February 1, 2022

Positive Dupixent^® (dupilumab) data across five diseases with underlying type 2 inflammation will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting from February 25 to 28. The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Additionally, positive results from two Phase 3 trials in a sixth indication, prurigo nodularis, were recently announced and will be presented at a separate medical meeting later this year.

Abstracts being presented at the AAAAI meeting have been published in an online supplement to The Journal of Allergy and Clinical Immunology and include:

Late-breaking Abstracts

New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. The use of Dupixent in these diseases is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.

Oral Presentation L01 (February 26, 2:00-3:15 pm MST): Dupilumab Significantly Reduces Itch and Hives in Patients with Chronic Spontaneous Urticaria: Results from a Phase 3 Trial (LIBERTY-CSU CUPID Study A), Marcus Maurer
Oral Presentation L02 (February 26, 2:00-3:15 pm MST): Dupilumab Improves Clinical and Histologic Aspects of Disease in Adult and Adolescent Patients with Eosinophilic Esophagitis at Week 24: Results from Part B of the 3-Part LIBERTY EoE TREET Study, Marc Rothenberg and Evan Dellon

Asthma

New analyses evaluate Dupixent in patients aged six years and older with moderate-to-severe asthma. These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations.

Oral Presentation 189 (February 26, 2:00-3:15 pm MST): Long-Term Efficacy of Dupilumab in Patients with Asthma with and without Comorbid Chronic Rhinosinusitis/Nasal Polyposis, Andrew Menzies-Gow
Oral Presentation 190 (February 26, 2:00-3:15 pm MST): Efficacy of Dupilumab in the Prevention of Seasonal Exacerbations in Patients with and without Evidence of an Allergic Asthma Phenotype, Anju Peters
Poster 42 (February 26, 9:45-10:45 am MST): Dupilumab Efficacy in LIBERTY ASTHMA QUEST Patients with Uncontrolled, Moderate-to-Severe Asthma by Allergen Sensitization Status, Jonathan Corren
Poster 50 (February 26, 9:45-10:45 am MST): Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarkers in Children with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE, Leonard Bacharier
Poster 409 (February 27, 2:00-3:15 pm MST): Dupilumab Improves Asthma Control, and Allergic Rhinitis-Related Health-Related Quality of Life in Children with Uncontrolled Persistent Asthma with Comorbid Allergic Rhinitis, Alessandro Fiocchi
Poster 571 (February 28, 9:45-10:45 am MST): Long-Term Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarker Patients with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE, Michael Wechsler

CRSwNP

New analyses assess Dupixent in reducing the burden of disease for patients with CRSwNP. These include assessments on the reduction of systemic corticosteroid use and symptoms, such as loss of sense of smell and nasal congestion, as well as the increase in days with no symptoms.

Oral Presentation 430 (February 27, 2:05-2:15 pm MST): Dupilumab Achieves Durable Reduction in Severity of Symptoms Rated Most Important by Patients with Chronic Rhinosinusitis with Nasal Polyps, Claire Hopkins
Oral Presentation 431 (February 27, 2:15-2:25 pm MST): Dupilumab Improves Objective, Subjective, and Health-Related Quality of Life Outcomes in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Regardless of BMI ≥30 kg/m2 or Weight ≥90 kg: Post-hoc Analysis of the SINUS-24 and SINUS-52 Studies, Seong Cho
Oral Presentation 432 (February 27, 2:25-2:35 pm MST): Symptom Free Days in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps Treated with Dupilumab, Claus Bachert
Oral Presentation 434 (February 27, 2:45-2:55 pm MST): Dupilumab Leads to Reduction of Anosmia in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps, Andrew Lane
Poster 145 (February 26, 9:45-10:45 am MST): EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients: The EVEREST Trial, Lucia De Prado Gomez
Poster 377 (February 27, 9:45-10:45 am MST): Dupilumab Reduces Asthma Disease Burden and Recurrent SCS Use in Patients with CRSwNP and Coexisting Asthma, Mark Gurnell

EoE

In addition to the late-breaking abstract, a new analysis assesses the impact of Dupixent treatment on biomarkers of type 2 inflammation in patients with EoE. The use of Dupixent in EoE is investigational and has not been approved by any regulatory authority.

Oral Presentation 633 (February 28, 9:45-10:45 am MST): Dupilumab Reduces Biomarkers of Type 2 Inflammation in Adult and Adolescent Patients with Eosinophilic Esophagitis: Results from Parts A and C of a Three-Part, Phase 3 LIBERTY EoE TREET Study, Mark Rothenberg

Atopic Dermatitis

New data from a trial that evaluated improvements in skin barrier function for adults and adolescents with moderate-to-severe atopic dermatitis treated with Dupixent, as well as long-term safety results of Dupixent in adults, will be shared.

Poster 29 (February 26, 9:45-10:45 am MST): Dupilumab Treatment Significantly Improves Skin Barrier Function in Adult and Adolescent Patients with Moderate to Severe Atopic Dermatitis, Evgeny Berdyshev
Poster 30 (February 26, 9:45-10:45 am MST): Safety of Long-Term Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis up to 172 Weeks: Results from an Open-Label Extension (OLE) Trial, Andreas Wollenberg

In addition, results from an observational study highlight the disease burden of moderate-to-severe atopic dermatitis and unmet need in children.

Poster 22 (February 26, 9:45-10:45 am MST): The Patient Burden of Moderate-to-Severe Atopic Dermatitis (AD) in Children Aged <12 Years: Results From 732 Patients in the PEDIatric STudy in Atopic Dermatitis (PEDISTAD) Observational Study, Amy Paller

About Dupixent

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Dupixent is not an immunosuppressant and does not require lab monitoring. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.

Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 350,000 patients have been treated globally.

Dupilumab Development Program

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite^® technologies, such as VelocImmune^®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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