January 23, 2020
Not intended for U.S. and UK Media

Bayer submits application to European Medicines Agency for pre-filled syringe to administer eye medication Eylea®

Berlin, January 23, 2020 - Bayer has submitted an application to the European Medicines Agency (EMA) for a pre-filled syringe to administer Eylea® (aflibercept solution for intravitreal injection) for five retinal conditions. It is currently available in a vial, from which the physicians fill the syringe. If, the state-of-the-art pre-filled syringe is approved, it would provide physicians with a new option for treatment that would require fewer steps to prepare for intravitreal injection.

"For many people living with retinal diseases and associated visual impairment, Eylea is a proven treatment option that consistently delivers excellent outcomes in reducing preventable vision loss both in randomized clinical studies and real-world clinical settings," said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Bayer Chief Medical Officer. "Bayer is committed to further enhancing its treatment offering through the introduction of the pre-filled syringe."

Eylea has been approved in approximately 100 countries for five indications for adults, which includes the treatment of neovascular (wet) age-related macular degeneration and the treatment of visual impairment due to: macular edema following retinal vein occlusion (RVO; branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV). Around 30 million vials of Eylea have been sold since its launch worldwide, resulting in over four million patient years of experience.

Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to Eylea in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales. In August 2019, Regeneron received U.S. Food & Drug Administration (FDA) approval for the pre-filled syringe for Eylea.

About VEGF and Eylea® (aflibercept solution for injection into the eye)
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.

Aflibercept solution for injection is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.com.

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Forward-looking statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.



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