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Bayer Healthcare and Regeneron Pharmaceuticals Inc. have agreed to collaborate on the development of the vascular endothelial growth factor (VEGF) Trap through a global plan that encompasses the neovascular form of age-related macular degeneration (AMD), diabetic eye diseases, and other eye diseases and disorders. The companies jointly will commercialize the VEGF Trap-Eye outside the United States and will share equally in profits from ex-U.S. sales. Within the United States, Regeneron has exclusive commercialization rights in all indications and will retain 100% of profits from any such sales.
Bayer Healthcare and Regeneron Pharmaceuticals Inc. have agreed to collaborate on the development of the vascular endothelial growth factor (VEGF) Trap through a global plan that encompasses the neovascular form of age-related macular degeneration (AMD), diabetic eye diseases, and other eye diseases and disorders. The companies jointly will commercialize the VEGF Trap-Eye outside the United States and will share equally in profits from ex-U.S. sales. Within the United States, Regeneron has exclusive commercialization rights in all indications and will retain 100% of profits from any such sales.
Under the terms of the agreement, Bayer will make an upfront payment of $75 million to Regeneron; Bayer and Regeneron will share initial global development costs.
If a VEGF Trap-Eye product is granted marketing authorization in a major market country outside the United States, Regeneron, from its 50% share of VEGF Trap-Eye profits outside the United States, will reimburse Bayer for 50% of the development costs that Bayer incurred.
Regeneron can earn up to $110 million in total development and regulatory milestones related to the development of the VEGF Trap-Eye for wet AMD and diabetic macular edema (DME) (or other major eye indication) and marketing approvals in major market countries outside the United States. A total of $40 million of these milestone payments is due upon the initiation of phase III clinical trials in wet AMD and DME. Regeneron can earn up to $135 million in sales milestones when total annual sales of the VEGF Trap-Eye outside the United States achieve certain specified levels starting at $200 million.
Currently in phase I clinical trial for wet AMD and phase II clinical trial for DME, VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A and related placental growth factor. The VEGF Trap-Eye blocks the interaction of these growth factors with cell-surface receptors, thereby preventing the subsequent formation of the new blood vessels that play an important role in the development of eye diseases such as wet AMD.