Regeneron, Bayer to develop new wet AMD treatment

Tarrytown, NY-Regeneron Pharmaceuticals and Bayer HealthCare have 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 aflibercept (Eylea) for the treatment of wet age-related macular degeneration (AMD).

“Bayer has been a great collaborator in the development and commercialization of (aflibercept) outside the United States,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. “We look forward to building our relationship in ophthalmology with this potential next-generation product candidate.”

Preclinical data have suggested that combining PDGFR-beta blockade with vascular endothelial grown factor (VEGF) blockade by aflibercept can provide advantages over inhibiting VEGF alone in the treatment of wet AMD.

First human clinical studies of the combination therapy are currently planned to begin in early 2014.

“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, MB, BS, 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.”

Under the terms of the agreement, Bayer will make an upfront payment of $25.5 million to Regeneron and will share global development costs for the program. Bayer 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 United States, Regeneron has exclusive commercialization rights and will retain 100% 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, and Bayer is responsible for certain payments due to a third party, including royalties on ex-U.S. sales and a share of development milestones.

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