Get the Latest Investment Ideas Delivered Straight to Your Inbox.

TICKERS: REGN, SNY

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

Source:

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%).

[NLINSERT]

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.




Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Life Sciences Report Newsletter Free and be the first to know!

A valid email address is required to subscribe