Featured Company News - Regeneron and Sanofi Receive Positive CHMP's Opinion for Dupixent(R)

MAIN, GERMANY / ACCESSWIRE / July 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=REGN. The Company and Sanofi (NYSE: SNY) announced on July 21, 2017, that European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the marketing authorization of their drug Dupixent® (Dupilumab). The committee has recommended its license for use in adults who suffer from moderate-to-severe atopic dermatitis (AD) and are candidates for systemic therapy. Dupixent® is the first investigational targeted biologic in the EU to receive positive CHMP's opinion for atopic dermatitis. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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What is Atopic Dermatitis (AD)?

AD, also known as atopic eczema is a form of eczema, a chronic inflammatory disease with symptoms such as a rash on the skin. In cases of moderate to severe AD, patients get rashes on most parts of their body, with extreme, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itchiness is the most troublesome symptom that can severely weaken patients. At times, people with moderate to severe AD also show symptoms of disrupted sleep, increased anxiety, and depression.

In the United Kingdom, nearly 1.5 million (i.e. 3%) adults have AD. Within UK's population, it is assessed that there are about 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with Dupixent®.

How does Dupixent® Cure AD?

Dupixent® is an investigational fully human monoclonal antibody that has been specially designed to restrain overactive signaling of two key proteins IL-4 and IL-13. IL-4 and IL-13 are the main drivers of the inflammation in AD. Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, are jointly developing Dupixent®.

If this drug is approved, it will be available in a pre-filled syringe for self-administration by a patient. It is to be taken as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids.

In the US, Dupixent® has been approved for the treatment of adults who have moderate to severe AD and whose disease is not properly controlled by topical prescription therapies, or in cases when those therapies are not advisable.

Some views from the industry

Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust stated that people suffering from AD live with a life-long condition that has intolerable symptoms impacting all aspects of their lives. He mentioned that doctors have had very few options to treat patients with this disease until now. He believes if Dupixent® is approved, it will be a greatly welcomed treatment option.

Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme also had a similar opinion. He agreed that AD is a disease that can have a detrimental impact on a person's quality of life, causing physical discomfort and often emotional distress. He applauded CHMP's positive recommendation for Dupixent®. He said it is an important step for introducing an innovative treatment option for patients who are suffering from AD.

European Commission (EC) decision pending

Going by the common trend, the European Commission's (EC) final decision on the Marketing Authorization Application (MAA) for Dupixent® in the European Union is expected in the coming months. The CHMP's opinion is based on studies from the global LIBERTY AD clinical trial program, which includes SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS, and CAFÉ. These studies have included data from approximately 3,000 adult patients who had moderate to severe AD that was not properly controlled by topical prescription therapies or immunosuppressants such as cyclosporine, or in cases when those therapies were not advisable. In clinical trials, the common side effects noted were injection site reactions, viral infections such as herpes affecting the mouth, dry eye, and similar symptoms affecting the eye.

On March 14, 2017, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) had also granted Dupixent® a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

Dupixent to be a Growth Driver

It is expected that Dupixent® will become a differentiator and an important growth driver for Regeneron Pharma and Sanofi in the coming times.

About Regeneron Pharmaceuticals, Inc.

Regeneron Pharma is a prominent biotechnology Company that invents life-transforming medicines for people with serious diseases. Physician-scientists founded it about 30 years ago. Its unique capability to unswervingly translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in their laboratories. The Company produces medicines to cure patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases as well as rare diseases.

About Sanofi

Sanofi is a leading healthcare Company that discovers, develops, and distributes therapeutic solutions focused on patients' varied needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular; General Medicines and Emerging Markets; Sanofi Genzyme; Sanofi Pasteur; and Consumer Healthcare. Of these, Sanofi Genzyme emphasizes on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Last Close Stock Review

At the closing bell, on Friday, July 21, 2017, Regeneron Pharma's stock slipped 1.00%, ending the trading session at $515.92. A total volume of 617.66 thousand shares have exchanged hands. The Company's stock price skyrocketed 39.39% in the last three months, 42.30% in the past six months, and 32.45% in the previous twelve months. Moreover, the stock soared 40.54% since the start of the year. The stock is trading at a PE ratio of 62.07 and currently has a market cap of $54.85 billion.On Friday, July 21, 2017, the stock closed the trading session at $47.71, slightly down 0.73% from its previous closing price of $48.06. A total volume of 941.58 thousand shares have exchanged hands. Sanofi's stock price surged 8.21% in the last three months, 18.24% in the past six months, and 13.87% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 17.98%. The stock is trading at a PE ratio of 23.04 and has a dividend yield of 3.44%. At Friday's closing price, the stock's net capitalization stands at $121.23 billion.

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