March 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TARRYTOWN, N.Y. – A rheumatoid arthritis drug jointly developed by Regeneron Pharmaceuticals and Sanofi outperformed AbbVie ’s Humira in a Phase III trial, the companies said in a joint statement this morning.
Regeneron and Sanofi said its experimental sarilumab improved the signs and symptoms of rheumatoid arthritis (RA) patients after 24 weeks of use. Sarilumab is an investigational, human IL-6 receptor antibody designed to inhibit the inflammatory activity in. IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA, and levels of IL-6 correlate with both disease activity and joint destruction, the companies said.
Rheumatoid arthritis is the most common form of autoimmune arthritis. It’s a painful affliction affecting the hands and joints, but there are numerous treatments, such as Genentech ’s Rituxan or AbbVie’s Humira, that provide tremendous relief to patients. If approved, Sanofi and Regeneron’s sarilumab could become part of that treatment regimen. In January, the companies announced the U.S. Food and Drug Administration accepted the biologics license application for sarilumab for review. The FDA has a target action date of Oct. 30, 2016.
Janet van Adelsberg, Regeneron’s Senior Director, Clinical Sciences, Immunology and Inflammation, said the data was the first time an injectable IL-6 receptor blocker demonstrated superiority over adalimumab monotherapy (Humira) in RA.
Sanofi’s Simon Cooper, head of immunology and inflammation at the French-based company, said the trial data suggests sarilumab “may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.”
“Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients,” Cooper said in a statement.
If approved sarilumab is expected to generate $557 million in annual revenue by 2022, Bloomberg reported this morning.
Shares of Sanofi and Regeneron were both up this morning following news of the RA treatment outperforming the blockbuster Humira. Sanofi was up about 2 percent, trading at $41.31 per share, while Regeneron was up about 1 percent, trading at $381.20 per share.
The work on sarilumab is not the only alliance Regeneron has with Sanofi. Last year, the U.S. Food and Drug Administration approved Praluent, the PSCK9 inhibitor developed by both companies.
Not only could sarilumab become a rival for Humira, Amgen is in the process of developing a biosimilar for AbbVie’s blockbuster RA treatment. In Oct. 2015, Amgen, which makes the RA treatment Enbrel, announced positive Phase III results of ABP 501, a biosimilar to Humira (adalimumab) in patients with rheumatoid arthritis. Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. The FDA is expected to review the drug for approval by October 30, 2016.
