Regeneron and Sanofi Partnership Records Another Hit In Latest String of Successes
May 21, 2015
By Mark Terry and Riley McDermid, BioSpace.com Breaking News Staff
Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. announced today that its Phase III trial of sarilumab for rheumatoid arthritis (RA) met its co-primary efficacy endpoints. This is just the most recent in a string of successes for Regeneron and its partnership with Paris-based Sanofi .
Regeneron did not respond to a request for interview by deadline.
The clinical trial, dubbed SARIL-RA-TARGET, jointly run by Regeneron and Sanofi, studied sarilumab, a fully human IL-6 receptor antibody in patients with RA compared to placebo. In the study, 546 patients were randomized to one of three treatment groups that received 200 milligrams of sarilumab, 150 milligrams of sarilumab, or placebo in addition to non-biologic disease modifying anti-rheumatic drugs (DMARD).
At 24 weeks patients showed a score of 20 percent improvement. In the 200 milligram group, there was 61 percent who showed improvement, 56 percent in the 150 milligram group, and 34 percent in the placebo group. Also, at 12 weeks, there was recorded improvement in physical function.
The companies also have two additional related RA trials, SARIL-RA-EASY and SARIL-RA-ASCERTAIN. Both of these trials met their primary endpoints as well.
In a joint statement the companies indicated that they expect to seek approval for the drug in the U.S. in the fourth quarter of this year.
The two companies’ joint operations are on a roll. On March 16, 2015, BioSpace reported published data in the New England Journal of Medicine regarding two cholesterol medications. One of the drugs, alirocumab, co-developed by Sanofi and Regeneron, showed significant effects in lowering LDL cholesterol. In the same issue, an Amgen drug, evolocumab, also showed significant positive effects.
“Reductions were seen in all classes of adjudicated events,” wrote Geoffrey Porges, a biotech analyst with Sanford Bernstein, in a note to investors in March. “It is worth noting, however, that the absolute incidence of events in this sample was very low. Only 60 adjudicated cardiovascular events occurred in the OSLER-1 and OSLER-2 sample over the year followed.”
The business partnership between Regeneron and Sanofi has been going on for several years. The companies reported in February 2013 that Sanofi was buying up Regeneron stock, owning about 16.7 percent of the company, or 15.82 million shares. Under the terms of their relationship, Sanofi can own up to 30 percent of Regeneron until 2017. “The 30 percent limit they can acquire without our permission is in force and will remain in force” until 2022, said Peter Dworkin, a spokesman for Regeneron in a 2013 statement.
The two companies also published positive pivotal Phase IIb trial data for the treatment of asthma using dupilumab at the American Thoracic Society 2015 International Conference on May 18.
“Despite available treatments, many patients with asthma continue to have symptoms and recurring attacks, which have a serious and detrimental impact on their daily lives,” said Sally Wenzel, lead investigator from The University of Pittsburgh, Division of Pulmonary, Allergy and Critical Care Medicine in a statement.
“In the study, dupilumab added to standard-of-care therapy demonstrated fewer exacerbations and improved lung function across both the high and low baseline eosinophil groups. We look forward to the continued clinical development of dupilumab as a potential option for a broad population of patients with uncontrolled asthma.”
Last fall Regeneron and Sanofi (SAN.PA) saw positive results or a Phase 2b study for dupilumab, which holds an enormous amount of promise for both investors and clinicians looking for a “potential blockbuster” for the treatment of allergic diseases, biotech analyst Joshua Schimmer said at the time.
The companies announced positive from the study of dupilumab and standard of care in 776 adults with uncontrolled moderate to severe asthma. Dupilumab had broad efficacy in all patients, but the response was strongest in patients with high eosinophils. Dupilumab also reduced the annualized rate of severe exacerbations.
Those results are good news for both firms, said Schimmer, who is with Piper Jaffray.
“The partners plan to advance dupilumab into Phase III trials based on these data,” he wrote in a note to investors. “When combined with the positive data in sinusitis and dermatitis, we are optimistic for dupilumab's broad potential in allergic diseases.”
All of those numbers are encouraging enough to have Wall Street wondering if the drug has the potential to be a major tool in treating allergic diseases going forward.
“Dupilumab's mechanism of targeting IL-4/IL-13 seems to offer an efficacious therapy for treating a broad range of allergic diseases,” said Schimmer in his note. “[This] data in asthma, the recent results in sinusitis and commencement of Phase III trials in atopic dermatitis position dupilumab to have blockbuster potential in allergic conditions.”
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