- Regeneron is looking to develop a sustained release version of its top selling Eylea (aflibercept), and has tapped Bedford, MA-based Ocular Therapeutix to reach that end.
- The Tarrytown, NY provider of eye disease and cholesterol medicines will pay $10 million upfront for access to Ocular’s technology, namely an in-development hydrogel-based capsule that can extend the length of time a drug is released in the body. An additional $305 million in milestone payments is also on the table.
- The deal gives Regeneron an exclusive rights option to that technology, but only when used to target vascular endothelial growth factors (VEGF), which are associated with eye disease. The company has up to 18 months to claim exclusivity, while Ocular can license out the capsules to other pharmaceutical manufacturers in other indications.
Ocular will pay for all of sustained release Eylea’s preclinical and Phase 1 expenses under deal terms. Regeneron will be in charge of everything—including clinical trials and marketing—for Phase 2 and beyond. Ocular also stands to collect tiered royalties in the high single-digit to mid teen-digit range.
In an Oct. 13 investor call, Ocular Chief Financial Officer Brad Smith said the $10 million initial payment will likely be enough to cover preclinical expenses, but that his company would have to pick up the tab for any additional spending through Phase 1 completion. He declined to state when in-human trials would commence.
Smith further revealed that a joint research committee consisting of three representatives from each company would oversee the drug’s development, though Regeneron will have final say on any issues that come before the board.
Prior to the deal, Ocular and Regeneron had been informally working together for about two years, according to Ocular’s CEO Amar Sawhney. Their current partnership is necessary, he said, as Regeneron provides the necessary know-how to tackle anti-VEGF treatments.
"The proteins are tricky molecules, so they are harder to deliver over an extended period of time; they denature easily, they aggregate easily," Sawhney said in the Oct. 13 call. "This is why extended delivery of protein-based anti-VEGF agents has been a difficult hill to conquer."
"Eylea is a hard drug to beat," Sawhney said. "It is the best drug out there, and the biosimilar world has not caught up yet. For us to proceed into this realm, it is best for us to proceed with a partner, and a partner with the pedigree of Regeneron makes the most sense."
Sawhney added that some of the hydrogel capsule technology’s patents extend to 2034, thereby providing long-lasting patent protection to any drug it pairs with, including Eylea.
The deal comes as industry followers foresee rapid growth in the greater ophthalmology market. A Global Business Intelligence report from August stated that worldwide ophthalmology revenues are expected to increase from $13.7 billion in 2015 to $26 billion by 2022.
Eylea saw sales of $831 million in the second quarter, according to Regeneron’s most recent 10-Q form filed with the Securities and Exchange Commission. Last year, the drug brought in $2.68 billion.