Regeneron/Sanofi Gets Positive CHMP Opinion for Dupixent

Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the label expansion of asthma drug, Dupixent (dupilumab), in a third indication.

The CHMP recommended the approval of Dupixent as 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.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.

The positive opinion of the committee was based on two pivotal phase III trials — the 24-week SINUS-24 and 52-week SINUS-52 — which evaluated Dupixent 300 mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.

The European Commission (EC) generally considers the CHMP recommendation while approving a drug but isn’t bound by it.

If approved, Dupixent will be the first biologic medicine available in the European Union (EU) to treat this disease.

We note that Dupixent is already approved in the United States and the EU for moderate-to-severe atopic dermatitis and certain patients with asthma. It is also approved in the United States for use with other medicines to treat CRSwNP in adults whose disease is not controlled.

Label expansion of the drug into additional geographies should further boost sales, which have been strong in the first half of the year.

Regeneron gained 3.4% on the news. However, the stock has lost 20.6% in the year so far compared with the industry’s decline of 0.6%.

Meanwhile, both companies are working to further expand the drug’s label. It is being evaluated for pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis, chronic obstructive pulmonary disease, and food and environmental allergies. It is also being studied in combination with REGN3500 (SAR440340), which targets IL-33.

Strong Dupixent sales have diversified Regeneron’s revenue base and reduced dependence on the lead drug, Eylea. The approval of skin cancer drug, Libtayo, has also strengthened the company’s portfolio.

Regeneron’s efforts to develop pipeline and diversify its revenue base are impressive. It earlier extended the collaboration agreement with Alnylam Pharmaceuticals, Inc. ALNY to discover, develop and commercialize new RNA interference (RNAi) therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.

Zacks Rank & A Stock to Consider

Regeneron currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same space is Amgen, Inc. AMGN, which sports a Zacks Rank #1 (Strong Buy), currently.  You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings estimates have moved up by 40 cents to $14.30 for 2019 over the past 60 days.

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