As the stock market was closing yesterday, Regeneron (NASDAQ: REGN) announced long-awaited data from a mid-stage trial of a rheumatoid arthritis drug it is developing with French drug giant Sanofi-Aventis (NYSE: SNY). The companies said that patients taking the drug, an antibody called sarilumab (REGN88/SAR153191), along with the commonly used treatment methotrexate achieved a significant improvement in symptoms of the painful joint disease. The only spot of negative news was that the drug did not perform well in separate trial in patients with another inflammatory disease, ankylosing spondylitis.
Regeneron and Sanofi are now determining the optimal dose to move forward into a Phase 3 trial in rheumatoid arthritis, making sarilumab the latest in a string of late-stage drug candidates to come out of Regeneron and Sanofi’s eight-year development collaboration. The partnership is one of four key Big Pharma alliances that Tarrytown, NY-based Regeneron has formed. Those collaborations explain why the company is counted among the top 10 biotechs in the country, despite the fact that it only has one product on the market to treat a rare disease, says Murray Goldberg, Regeneron’s CFO. “Here’s little old Regeneron, with one product selling about $20 million a year, but if you look at employee count and R&D spend, we’re in the top tier,” Goldberg says. “We’ve only been able to do it because of the collaborations.”
Now Regeneron is on the cusp of becoming a fully commercial organization. The FDA is expected to approve Regeneron’s drug to treat age-related macular degeneration, aflibercept (Eyelea), by August 20. Regeneron developed the drug in a deal with Bayer HealthCare, which has the rights to market it overseas. But Regeneron is responsible for U.S. sales—a challenge that will bring it into a competitive market ruled by Roche subsidiary Genentech, which makes the $3-billion-a-year blockbuster ranibizumab (Lucentis). Regeneron is now in the process of building a salesforce armed to fight “a formidable competitor,” Goldberg says.
The impending approval marks a milestone in Regeneron’s history. Founded in 1988, the company first gained recognition for its technologies designed to develop protein-based drugs. One of those technology platforms, called Trap, blocks … Next Page »