April 08, 2020
Not intended for U.S. and UK Media

Bayer launches pre-filled syringe to administer eye medication Eylea® in Europe

Berlin, April 8, 2020 - The European Medicines Agency (EMA) has granted approval for the new Eylea® (aflibercept) injection pre-filled syringe. This new presentation provides ophthalmologists with a more efficient and convenient way to administer EYLEA across all approved indications, as the pre-filled syringe requires fewer steps to prepare compared to the intravitreal injection procedure of the existing vial. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

"Eylea is the only approved anti-VEGF therapy successfully extended up to four-month (16 weeks) treatment intervals in clinical trials, with a Treat & Extend dosing regimen and overall delivers excellent outcomes to reduce preventable vision loss," said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Bayer Chief Medical Officer. "Together with the new pre-filled syringe presentation, which promises to benefit both physicians and patients, Bayer maintains its position as a leader in this field".

Bayer has recently published the results from the Phase IV ALTAIR study, which confirmed the effectiveness of Eylea® (aflibercept) with Treat and Extend (T&E) dosing regimens in wet age-related macular degeneration (wet AMD). The promising results demonstrated a considerable injection burden reduction, since up to 60% patients were able to achieve injection intervals of three-months (12-week interval) or more whilst more than 40% achieved injection intervals of four-months (16-week interval). Eylea is the only approved anti-VEGF to successfully extend to 16-week treatment intervals in clinical trials with a T&E dosing regimen.

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 Eylea® (aflibercept solution for injection into the eye) and VEGF
Eylea has been approved in approximately 100 countries (ex U.S.) for five indications for adults, which includes the treatment of neovascular wet AMD 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). Over 31 million vials of Eylea have been sold since its launch worldwide, resulting in over four million patient-years of experience.

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 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 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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