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Sanofi SNY and partner Regeneron Pharmaceuticals REGN announced that a phase III study evaluating its atopic dermatitis (eczema) drug Dupixent (dupilumab) in adolescent patients (aged 12-17) met its primary and key secondary endpoints.
The primary endpoint of the study was the proportion of patients achieving Investigator's Global Assessment (“IGA”) score of 0 (clear) or 1 (almost clear) skin at week 16. A co-primary endpoint outside the United States and a key secondary endpoint in the United States was the proportion of patients who achieved 75% or greater skin improvement as measured by the Eczema Area and Severity Index (EASI-75) at week 16.
Patients were randomized in one of the three treatment groups for the controlled period of 16 weeks. 24% of patients who were treated with weight-based dosing of Dupixent subcutaneous injection 200 mg or 300 mg every two weeks and 18% of patients who were treated with 300 mg Dupixent every four weeks achieved the primary endpoint – clear or almost clear skin.
75% or greater skin improvement was observed in 41.5% of patients who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks. While in placebo the improvement was only 8%.
The study also showed that 66% improvement from baseline in EASI score in patients who received Dupixent every two weeks group and 65% improvement in patients who received every four weeks compared with a 24% improvement in the placebo group.
Detailed results from the study will be presented at a future medical meeting. These data will be submitted to regulatory authorities later in 2018.
Shares of Sanofi have declined 11.3% compared with the industry’s fall of 4% year to date.
We note that Dupixent injection is presently marketed in the United States for the treatment of adults with moderate-to-severe AD. It is the first and only biologic medicine approved for the treatment of adults suffering from AD. It was approved in the United States in March last year. It was approved for AD in the EU in September last year.
Apart from AD, Dupixent is also being evaluated for eosinophilic esophagitis and other inflammatory indications including asthma and nasal polyposis in late stage studies.
Dupixent generated sales of €107 million in the first quarter of 2018 compared with €118 million in the previous quarter. A potential label expansion of the drug will further boost sales.
Zacks Rank & Stocks to Consider
Sanofi has a Zacks Rank #3 (Hold)
Some better-ranked stocks from the same space worth considering are Ligand Pharmaceuticals LGND and Enanta Pharmaceuticals, Inc. ENTA. While Ligand sports a Zacks Rank #1 (Strong Buy), Enanta carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up from $3.91 to $4.24 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 35.4% year to date.
Enanta’searnings per share estimates have moved up from 86 cents to $2.97 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 372.02%. The stock has rallied 78.3% so far this year.
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