Regeneron Pharmaceuticals and Ocular Therapeutix™ will partner to develop a sustained release formulation of aflibercept for wet age-related macular degeneration (wet AMD) and other serious retinal diseases, through a collaboration that Ocular said today could generate for it up to $315 million-plus.
Ocular Therapeutix said the companies will work to advance its sustained release formulation—now in preclinical development—into the clinic, but gave no timeframe for when that is expected to occur. In a separate statement today, Ocular CMO Jon Talamo, M.D., cited preclinical studies that have shown up to six months of sustained release of anti-vascular endothelial growth factor (VEGF) drugs using the company’s hydrogel-based drug delivery technology.
The companies’ agreement gives Regeneron the option for an exclusive license to use the hydrogel-based technology for the development and commercialization of a sustained release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications.
In addition to wet AMD, those indications include diabetic macular edema and retinal vein occlusion.
“This sustained release formulation could have the potential to significantly reduce dosing frequency and subsequently reduce doctor visits, thus reducing the burden of care for patients, caregivers and physicians, and may decrease the likelihood of certain side effects associated with frequent intravitreal injections,” Amar Sawhney, Ph.D., President, CEO, and Chairman of Ocular Therapeutix, said in a statement.
Should Regeneron exercise its option, it will pay Ocular Therapeutix $10 million. Ocular has agreed to fund development through Phase I, while Regeneron would be responsible for any subsequent development and commercialization costs.
Regeneron has agreed to pay Ocular Therapeutix up to $305 million in payments tied to achieving milestones toward a sustained release version of aflibercept containing Ocular Therapeutix’s sustained release hydrogel depot. The payments would consist of up to $155 million for development and regulatory milestones, $100 million for the first commercial sale, and up to $50 million in commercial milestone payments.
Ocular Therapeutix is also eligible to receive from Regeneron tiered high single-digit to low-to-mid teen-digit royalties on potential future net sales.
Ocular Therapeutix said it will retain all rights to develop its sustained-release hydrogel-based drug delivery platform with all other non-VEGF targeting compounds as well as with small molecule pharmaceuticals, including TKIs, for other retinal diseases.
The collaboration reflects Ocular Therapeutix’ focus on developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection capable of being formulated with both small and large molecule pharmaceuticals, including tyrosine kinase inhibitors and protein-based anti-VEGFs. The depots are intended to of deliver sustained and therapeutic levels of drugs to targeted ocular tissues.