Eleven Biotherapeutics has entered into an exclusive worldwide licensing deal with Roche, giving Roche development and commercialization rights to EBI-031, an interleukin-6 (IL-6) antagonist that is currently under review by the FDA. Eleven filed an Investigational New Drug (IND) application for EBI-031 with the U.S. Food and Drug Administration in June in order to get clearance to test in humans.
Under the terms of the deal, Eleven will receive a $7.5 million upfront, and $22.5 million when the IND becomes effective. Beyond that, potential milestones are $240 million, bringing the total potential take to $270 million.
- Currently, the ocular market is dominated by anti-VEGF drugs like Roche’s Lucentis (ranbizumab) and Regeneron’s Eylea (aflibercept) that treat conditions like age-related macular degeneration (AMD), diabetic retinopathy and diabetic macular edema (DME).
At the moment, there are only two FDA-approved IL-6 monoclonal antibodies, including Roche’s Actemra (tocilizumab) and Janssen’s Sylvant (situximab). Actemra and Sylvant are approved for treatment of rheumatoid arthritis (RA) and Castleman’s disease, respectively.
In addition, GlaxoSmithKlune and Eli Lilly both have IL-6 drugs in development, both for RA. And in January, Sanofi/Regereron filed their application for sarilumab, which is also intended to treat RA, with the FDA.
For years, researchers have been trying to leverage the anti-inflammatory effect of IL-6 inhibition in ocular therapeutics. Eleven Bio is the first company to bring an IL-6 drug for ocular therapy to the IND stage. EBI-031, which is delivered via intravitreal injection, was designed using the company’s AMP-R platform. The platform is included in the deal with Roche, potentially giving rise to the development of a whole new class of therapeutics for ocular disease.
Roche and Regeneron are competing head-to-head in the market for retinal diseases; however, after being the market leader for years, Roche’s Lucentis has started to lose ground to competitor Eylea. Last year, Lucentis generated roughly $1.52 billion in revenues, down 15% from 2014. Meanwhile, Eylea had global revenues of $4.1 billion, a 47% year-over-year increase from 2014.
If Roche and Eleven can successfully bring EBI-031 to market for any of the target indications—AMD, diabetic retinopathy, DME and potentially more—the upside will more than offset declining Lucentis revenues. The UK-based market research company, Vertical Edge Limited, predicts that the retinal diseases market will generate $10 billion in revenues next year, with strong potential for continued growth.