Regeneron Pharmaceuticals and Bayer HealthCare today announced an agreement to jointly develop an innovative antibody to the Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) as a potential combination therapy with EYLEA (aflibercept) for the treatment of wet age-related macular degeneration (wet AMD).
Preclinical data suggests that combining PDGFR-beta blockade with vascular endothelial growth factor (VEGF) blockade by EYLEA can provide advantages over inhibiting VEGF alone in the treatment of this devastating eye disease. First in human clinical studies are currently planned to begin in early 2014.
"Bayer has been a great collaborator in the development and commercialization of EYLEA outside the U.S.," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "We look forward to building on our relationship in ophthalmology with this potential next generation product candidate which will combine Regeneron's PDGFR-beta antibody and EYLEA in a single intravitreal injection." "Given the multi-factorial nature of wet AMD, there is a potential for additional benefits to patients by addressing different pathways responsible for this devastating condition," said Kemal Malik, M.B., B.S., Member of the Bayer HealthCare Executive Committee and Head of Global Development. "Inhibition of PDGF is one such pathway and we are looking forward to developing a potential combination therapy together with Regeneron. Bayer is strongly committed to expanding its ophthalmology research and development efforts with innovative treatment options and this new development candidate complements our own pipeline perfectly." Under the terms of the agreement, Bayer HealthCare will make an upfront payment of $25.5 million to Regeneron and will share global development costs for the program. Bayer HealthCare will have exclusive commercialization rights to the combination product outside the United States where they will share profits from ex-U.S. sales equally with Regeneron. Within the U.S., Regeneron has exclusive commercialization rights and will retain 100 percent of the profits from sales. Under the agreement, Regeneron is eligible to receive up to $40 million in option and milestone payments through regulatory approval from Bayer HealthCare, and Bayer HealthCare is responsible for certain payments due a third party, including royalties on ex-U.S. sales and a share of development milestones.