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Regeneron, Bayer Collaborating on Eye Disorder Drug

Woman's eyes

(Public Domain Pictures, Pixabay)

24 March 2016. Regeneron Pharmaceuticals and drug-maker Bayer AG are developing a combination of biologic drugs to treat the eye disorders wet age-related macular degeneration and diabetic macular edema. The agreement — the third such deal between the companies — is expected to bring Regeneron as much as $130 million if all milestones are met.

Age-related macular degeneration is a common eye condition and the leading cause of vision loss for people age 50 and over. The disorder causes damage to the macula, located near the center of the retina that the eye uses for central vision, to see objects in straight-ahead view. Diabetic macular edema is a complication of diabetes causing blurred vision and vision loss leading to blindness. It occurs when diabetes damages blood vessels in the eye, a condition known as diabetic retinopathy, resulting in leakage of blood and fluid, as well as swelling.

Regeneron, in Tarrytown, New York, collaborated with Bayer on development of aflibercept, a biologic drug marketed under the brand name Eylea that controls production of vascular endothelial growth factor-A, or VEGF-A, a protein that stimulates growth of blood vessels, but excessive production of the protein is a key factor in diseases of the retina. Aflibercept is given as an injection in the eye every four weeks.

The two companies are also working on rinucumab, an antibody addressing growth factors derived from blood platelets as a treatment for wet age-related macular degeneration. Rinucumab is being tested in intermediate-stage clinical trials, given with aflibercept as a single injection, rather than one given every four weeks.

In the new partnership, Bayer and Regeneron are creating a combination of biologics similar to rinucumab, combining aflibercept with the antibody nesvacumab developed by Regeneron that targets angiopoietin proteins. Angiopoietins are a family of growth factors that affect development of blood vessels, with the protein angiopoietin2 already shown to promote blood vessel growth when combined with VEGFs. The companies are evaluating the combination of aflibercept and nesvacumab as a single injection treatment for both wet age-related macular degeneration and diabetic macular edema.

The deal gives Bayer an exclusive license to commercialize the combination drug outside the U.S., while Regeneron retains commercialization rights inside the U.S.  Bayer is paying $50 million in an initial fee, with Regeneron eligible for another $80 million in development and regulatory milestones. Bayer and Regeneron will split profits from product sales outside the U.S., while Regeneron will keep all profits generated inside the U.S.

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