Press Release: Late Stage 3 COPD Results for Dupixent® (dupilumab) Presented at ATS and Simultaneously Published in the New England Journal of Medicine | market filter (2023)

Dupicente^®(dupilumab) COPD Phase 3 Late Results Presented at ATS isimultaneouslyit was not publishedNew England Journal of Medicine

• Dupixent is the first and only experimental COPD biologic to show a significant 30% reduction in moderate to severe acute exacerbations compared to placebo
• Dupixent is the first and only experimental COPD biologic to significantly improve lung function at weeks 12 and 52, with numerical improvements seen at 2 weeks
• Dupixent significantly improved quality of life, with numerical improvements as early as 4 weeks after treatment initiation and respiratory symptoms
• COPD is the third leading cause of death worldwide, with no new approved treatment approaches for more than a decade; the study included patients with moderate to severe disease and evidence of type 2 inflammation (ie, blood eosinophils ≥300 cells/µL)

ParismiTarrytown, New York May 21,2023. Positive results of the evaluation of the 3rd phase of the use of the Dupixent test^®(dupilumab) compared with placebo in adults currently receiving maximum standard inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation published today in 2023.International Conference of the American Thoracic Society (ATS)session "New England Journal of Medicine and JAMA". Debate on the Edge: Reports on Latest Published Pulmonary Research” and published simultaneously the no.New England Journal of Medicine(NEJM). These results will also be presented in the "Latest News: Results of Clinical Trials in Pulmonary Medicine" section onMay 22nd.

surya bhatt, MD, MSPH
Associate Professor inuniversity of alabamaYeahBirmingham Pulmonary Unit, allergy and critical care medicine and study co-principal investigator
"I have seen patients with uncontrolled chronic obstructive pulmonary disease struggle for a long time with the debilitating symptoms of this progressive disease.–with limited and gradual improvement over current treatment options. This study showed that dupilumab has the potential tostrikera vicious cycle of exacerbations and weakening of lung functionthey patients with uncontrolled COPD with type 2 inflammation,and significantly improve breathingsymptoms. Dupilumab also helped improve measures of health-related quality of life,OMS,of mineyear ofexperience as a doctor, they arejust as important to patients as the ability to breathe better.”

COPD is a life-threatening respiratory disease that damages the lungs and causes a progressive decline in lung function. Symptoms include a persistent cough and shortness of breath that can not only affect the ability to perform routine daily activities, but can also lead to anxiety, depression, and sleep disturbances. COPD is also associated with a significant health and economic burden due to repeated acute exacerbations that require treatment with systemic corticosteroids and/or lead to hospitalization or even death. Smoking and exposure to particulate matter are the main risk factors for COPD, but even people who quit smoking can develop or continue to develop the disease. inNAS.only about 300,000 people are living with uncontrolled COPD with evidence of type 2 inflammation.

Results presented in ATS and published inNEJMare from the BOREAS trial, which met the primary endpoints and all primary secondary endpoints. As shown and reported, patients receiving Dupixent (n=468) compared to placebo (n=471) added to maximal standard triple inhalation therapy experienced:

• 30% reduction in moderate to severe acute exacerbations of COPD over 52 weeks (p<0.001), primary endpoint.
• 160 mL improvement in lung function from baseline at 12 weeks vs. 77 mL (p<0.001).
  • Numerical improvements were observed at 2 weeks, and the benefit over placebo was maintained at 52 weeks (Dupixent: 153 mL, placebo: 70 mL; p<0.001).
• An improvement in health-related quality of life (QoL) of 9.7 points from baseline at 52 weeks vs. an improvement of 6.4 points (p = 0.002), with numerical values ​​of improvement observed at 4 weeks.
• A 2.7-point reduction in respiratory symptom severity (patient-reported outcome on a scale of 0 to 40) from baseline to week 52 vs. a 1.6-point reduction (p=0.001).

In a prespecified subgroup analysis of patients (Dupixent n=195, placebo n=188) with elevated levels (≥20 ppb) of fractionated exhaled nitric oxide (FeNO), a biomarker of type 2 inflammation in the airways, treatment with Dupixent also led to a significant 38% reduction in exacerbations compared to placebo at 52 weeks (p = 0.005). In this subgroup, Dupixent also produced a lung function improvement of 232 mL vs. placebo 108 mL at 12 weeks (p = 0.002) which was maintained at 52 weeks with a lung function improvement of 247 mL vs. 120 ml of the placebo (p = 0.003).

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. The overall adverse event (AE) rates were 77% for Dupixent and 76% for placebo. More frequently observed adverse events with Dupixent compared to placebo included headache (8.1% Dupixent, 6.8% placebo), diarrhea (5.3% Dupixent, 3.6% placebo), and back pain. (5.1% Dupixent, 3.4% placebo). More frequently observed adverse events with placebo compared with Dupixent included upper respiratory tract infection (9.8% placebo, 7.9% Dupixent), hypertension (6.0% placebo, 3.6% Dupixent ) and COVID-19 (5.7% placebo, 4.1% Dupixent). Adverse events leading to death were balanced between the two groups (1.7% placebo, 1.5% Dupixent).

A second Phase 3 repeat study of Dupixent in COPD with evidence of type 2 inflammation (NOTUS) is ongoing, with data expected in 2024. The safety and efficacy of Dupixent in COPD is currently under clinical investigation and not It has not been evaluated by any regulatory body. .sanofiand Regeneron hope to discuss the BOREAS data with regulators.

About EPOC Dupixentphase 3exam program
BOREAS is one of the two main tests in the Dupixent COPD programme. A Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Dupixent in 939 adult smokers or ex-smokers aged 40 to 80 years with moderate to severe COPD. All patients in the study had evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells/µL. Patients with a diagnosis or history of asthma were excluded from the study. During the 52-week treatment period, patients received either Dupixent or placebo every two weeks, in addition to maximum standard inhaled triple therapy of inhaled corticosteroids (ICS), long-acting beta-agonists, and long-acting muscarinic antagonists. Dual maintenance therapy was allowed if ICS were contraindicated.

The primary endpoint assessed the annual rate of moderate or severe acute exacerbations of COPD. Moderate exacerbations are defined as those requiring systemic administration of steroids and/or antibiotics. Serious exacerbations are defined as those: requiring hospitalization; requires more than one day of observation in an emergency department or urgent care center; or results in death.

Primary secondary endpoints and other hierarchical endpoints include:

• Change from baseline in lung function (assessed by forced expiratory volume in one second [FEV1] before bronchodilator) at weeks 12 and 52 in both the general population and those with FeNO ≥ 20 ppb.
• Change from baseline at week 52 in St. George's (SGRQ) compared with placebo (0-100 scale).
• Change from baseline after 52 weeks in COPD Respiratory Symptom Rating Scale (E-RS: COPD) score (range 0-40).
• Annual rate of moderate or severe acute exacerbations of COPD in patients with FeNO ≥ 20 ppb.

OjosanofimiRegeneron CPODclinical research program
sanofiand Regeneron are motivated to transform the COPD treatment paradigm by examining the role that different types of inflammation play in disease progression through investigation of two potentially pioneering biologics, Dupixent and Itepekimab.

Dupixent inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathway, and the program targets a specific population of people with evidence of type 2 inflammation. Itepequimab is a monoclonal antibody fully human that binds to and inhibits interleukin-33 (IL-33), an initiator and enhancer of systemic inflammation in COPD. Both programs have four ongoing Phase 3 trials designed to inform next-generation treatments for people with COPD who may not have other options.

Itepequimab is currently undergoing clinical investigation and its safety and efficacy have not been evaluated by any regulatory body.

O Dupixentu
Dupixent is a fully human monoclonal antibody that inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways and is not immunosuppressive. The Dupixent development program demonstrated significant clinical benefit and reduction in type 2 inflammation in phase 3 trials, establishing that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays an important role in multiple related diseases and often comorbidities. Those conditions include approved indications for Dupixent such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), and prurigo nodules.

Dupixent has received regulatory approvals in one or more countries worldwide for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, or prurigo nodulares in various age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, includingEuropa, oNAS.miJapan. More than 600,000 patients are treated with Dupixent worldwide.

Dupilumab Development Program
Dupilumab is being co-developedsanofiand Regeneron under a global collaboration agreement. To date, dupilumab has been studied in more than 60 clinical trials involving more than 10,000 patients with various chronic diseases caused in part by type 2 inflammation.

With currently approved indications,sanofiand Regeneron are studying dupilumab in a broad range of diseases caused by type 2 inflammation or other allergic processes in phase 3 trials, including pediatric EoE, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation. 2, and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and safety and efficacy in these conditions have not been fully evaluated by any regulatory body.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and markets life-changing medicines for people with serious illnesses. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and multiple product candidates in development, nearly all developed in our laboratories. Our line of medicines and products is designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematological conditions, infectious diseases and rare diseases.

Regeneron accelerates and improves the traditional drug development process through ourfast apartments^®technologies, such asVelocImune^®, which uses unique genetically humanized mice to produce optimized fully human and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which leads one of the world's largest gene sequencing efforts.

For more information, visit www.Regeneron.com or follow @Regeneron on Twitter.

Ojosanofi
We are an innovative global healthcare company, driven by one purpose: to pursue the wonders of science to improve people's lives. Our team, in nearly 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible possible. We bring life-changing treatment options and life-saving vaccine protection to millions of people around the world, placing sustainability and social responsibility at the heart of our ambitions.

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