A U.S. biotech has scored big in its collaboration with one of France’s largest drugmakers.
Tarrytown, New York-based Regeneron said Tuesday that the drug Dupixent (dupilumab) – under a partnership with Paris-based Sanofi – had shown positive top-line results in a Phase III trial among children with severe atopic dermatitis, while also winning approval in Europe for adolescents with moderate-to-severe disease. In addition, higher sales of the drug helped the company’s collaboration, which is focused on commercialization of monoclonal antibodies, to become profitable for the first time.
Data from the Phase III showed that 70 percent of patients who received a flat 300mg dose of Dupixent every four weeks, and 67 percent of those receiving it every two weeks at 100-200mg based on weight had 75 percent or greater skin improvement, compared with 27 percent of those on placebo. Thirty-three percent of those in the 300mg group and 30 percent of those in the 100-200mg group achieved clear or almost clear skin, compared with 11 percent of those on placebo. Conjunctivitis, nasopharyngitis and injection site reactions were more frequent among those receiving the drug. The randomized, double-blind, placebo-controlled study enrolled children aged 6-11 and randomized them to receive Dupixent with standard-of-care topical corticosteroids.
Shares of Regeneron were mostly flat on the Nasdaq Tuesday afternoon following the news.
“The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are very important because of the significant unmet needs in this patient population,” Regeneron President George Yancopoulos said in a statement, referring to the Phase III trial results. “Children in the trial had suffered from severe atopic dermatitis for most of their lives.”
Meanwhile, the drug won approval from the European Commission for treating adolescents aged 12-17 with moderate-to-severe atopic dermatitis. It was already approved in the European Union for adults. In the U.S., it has approval for adolescents and adults. It also has approval in the U.S. for adolescents and adults with certain forms of asthma and adults with chronic rhinosinusitis.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The partnership between the two companies has paid off in other ways as well.
In its second quarter earnings, Regeneron said its collaboration with Sanofi around monoclonal antibodies had, for the first time, become profitable on a quarterly basis. Revenue from the collaboration was $349.1 million for the quarter, compared with $237.8 million during the same period last year. Regeneron’s share of profits was $38.8 million, compared with a $68.8 million loss in second quarter 2018. Profits for the company in the first six months of this year were $11 million, compared with a $143.7 million loss during the first six months of 2018. The company said increased net sales of Dupixent were mostly responsible for the quarterly increase that led to the profit. Global net sales of the drug were $557 million, a 166 percent increase over second quarter 2018.
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