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Big biotech Regeneron Pharmaceuticals ( REGN ) and its big pharma partner Sanofi ( SNY ) said Friday that their potential blockbuster eczema drug candidate sailed through late-stage trials and would be submitted for approval in Q3 of this year. Regeneron shares spiked Friday, headed for their best one-day percentage gain in years. Regeneron’s and Sanofi’s drug dupilumab cleared or nearly cleared the symptoms of atopic dermatitis (eczema) in more than a third of patients, compared with less than 10% of patients in the placebo group, in two clinical trials comprising a total of 1,379 people. Patients on dupilumab in general average around a 70% improvement in the Eczema Area and Severity Index (EASI), whereas the placebo group improved in the 30% to 40% range. “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need,” Sanofi R&D head Elias Zerhouni said in a statement. “In the U.S., where dupilumab in AD (atopic dermatitis) has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.” Evercore ISI analyst Mark Schoenebaum wrote that analysts’ consensus peak annual sales estimate for dupilumab is $4 billion, but there’s quite a bit of variation between individual analysts. “We believe that the current debate for dupilumab is focused on the size of commercial opportunity — it is also in late stage studies for severe asthma (where dupilumab demonstrated high efficacy in phase two in an all-comers population) as well as chronic sinusitis with nasal polyps and eosinophilic esophagitis,” Schoenebaum wrote in an email to clients. “A/D is a relatively new market segment and dupilumab is one of the first therapeutic candidates that could address the high unmet need. … The commercial opportunity in severe asthma may be similarly attractive; however, dupilumab will be facing a more crowded competitive landscape in asthma.” Regeneron shares shot up 13.5% in afternoon trading on the stock market today to about 409, moving over its 50-day moving average for the first time in 2016. Regeneron stock touched a 17-month low below 349 on March 17. Sanofi stock rose a fraction, above 40. Scalper1 News
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