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Regeneron Reports Positive Phase 3 Dupixent Data; Gains EU Approval Recommendation

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Regeneron Pharmaceuticals published positive results from two U.S. Phase 3 trials evaluating the safety and efficacy of Dupixent (dupilumab) in adults with recurring severe chronic rhinosinusitis with nasal polyps. The European Medicines Agency's Committee for Medicinal Products for Human Use also adopted a positive opinion for Dupixent in a third indication.

Early this morning Regeneron Pharmaceuticals Inc. (REGN:NASDAQ) and Sanofi SA (SNY:NYSE) announced that The Lancet has published detailed positive results from two Phase 3 trials evaluating the safety and efficacy of Dupixent (dupilumab) in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids.

The report explains that CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages, which can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure.

Results published in the journal demonstrated that adding Dupixent to the standard-of-care corticosteroid nasal spray reduced nasal polyp size and nasal congestion severity (co-primary endpoints). Dupixent also reduced chronic sinus disease associated with nasal polyps and improved sense of smell. In addition to the results of the primary endpoints of these trials, the publication included a pre-specified pooled analysis that showed Dupixent significantly reduced systemic corticosteroid use by 74% and the need for sino-nasal surgery by 83% compared to placebo. Given that these patients frequently also suffer from asthma, the trials prospectively studied the effect of Dupixent on a subgroup of patients with a history of asthma, and found significant improvements in asthma control and lung function.

Claus Bachert, M.D., principal investigator of the trials and Professor and Head of Clinics of the Department of Otorhinolaryngology at Ghent University, commented, "The results published in The Lancet show that Dupixent improved all disease measures of chronic rhinosinusitis with nasal polyps in the trials...In patients with CRSwNP who have a history of asthma, Dupixent was also effective in improving asthma symptoms, lung function and asthma control, as well as upper airway outcomes. This is important news for these patients as they often suffer from high disease burden and are not controlled by standard treatment."

Dupilumab and REGN3500 were invented using Regeneron's proprietary VelocImmune technology that yields optimized fully human antibodies, and are being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Dupixent is approved in the U.S. for use with other medicines to treat CRSwNP in adults whose disease is not controlled, and is currently under regulatory review for these patients in the EU and Japan. In addition, Dupixent is approved for use in specific patients with moderate-to-severe atopic dermatitis, and certain patients with asthma in a number of other countries around the world, including the EU, U.S. and Japan.

In a separate release this morning, Regeneron and Sanofi also announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab) in a third indication. The CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

If approved, Dupixent would be the first biologic medicine available in the European Union (EU) to treat these patients. The positive CHMP opinion is based on two pivotal Phase 3 trials and a final decision on the Dupixent application by the European Commission (EC) is expected in the coming months.

In addition to the currently approved indications, Regeneron and Sanofi are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis, chronic obstructive pulmonary disease, and food and environmental allergies.

Regeneron describes itself as a leading biotechnology company that invents life-transforming medicines for people with serious diseases. The company has seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in its laboratories. The firm states that its medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.

Sanofi, based in Paris, France, is a $112.0 billion market cap global healthcare company involved in research, development, manufacture and marketing of therapeutic solutions. The company's Pharmaceuticals segment comprises the commercial operations of various franchises, including Diabetes and Cardiovascular, Specialty Care (Rare Diseases, Multiple Sclerosis, and Oncology), Established Prescription Products, and Consumer Healthcare and Generics. The Vaccines segment includes the commercial operations of the company's vaccines division Sanofi Pasteur.

REGN shares opened today at $288.75 (+2.60, +0.91%) over Thursday's closing price of $286.15. The stock has traded today between $286.68 and $297.64/share and presently is trading at $296.00 (+$9.85, +3.42%).


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