VEGF Trap undergoing global development

Leverkusen, Germany, and Tarrytown, NY-Bayer Healthcare and Regeneron Pharmaceuticals Inc. have entered into a collaboration agreement for the global development of the vascular endothelial growth factor (VEGF) Trap for possible treatment of the neovascular form of age-related macular degeneration (AMD), diabetic eye diseases, and other eye diseases and disorders.

The companies will jointly 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.

"The VEGF Trap is an excellent strategic fit for Bayer, which underscores our commitment to specialty pharmaceuticals," said Arthur Higgins, chairman of the board of management, Bayer HealthCare. "We are encouraged by the early clinical data that we've seen and believe the VEGF Trap has the potential to transform further the treatment paradigm for patients suffering from diseases of the eye."

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 are due on the initiation of phase III clinical trials in wet AMD and DME. Lastly, 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.

"As an established leader in specialty pharmaceutical products, Bayer is an ideal partner to help develop and commercialize the VEGF Trap outside the United States for eye disease," said Leonard S. Schleifer, MD, PhD, president and chief executive officer of Regeneron. "We look forward to working together with Bayer to develop the VEGF Trap-Eye aggressively for wet AMD, diabetic eye disease, and other eye diseases with unmet medical needs."

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.