October 30, 2015
Not intended for U.S. and UK Media

Bayer Receives EU Approval for EYLEA® for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization

Berlin, October 30, 2015 - Bayer has received approval from the European Commission for the eye drug EYLEA® (aflibercept solution for injection into the eye) in a fifth indication. EYLEA is now also approved for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is a disease of the retina associated with high degrees of myopia (near-sightedness) and frequently affects people of working age. Bayer plans for an immediate introduction to the market with Germany being one of the first launch countries in Europe.

"The results of the Phase III study were very encouraging with the majority of patients experiencing a significant two-line improvement in visual acuity on a standard eye chart with aflibercept solution for injection", said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "A treatment option that could not only prevent permanent vision loss, but also improve visual acuity could have great benefits for patients with myopic CNV."

EYLEA® is already approved for the treatment of patients with wet age-related macular degeneration, for the treatment of visual impairment due to diabetic macular edema, and for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). Over five million doses of EYLEA have been administered worldwide since its launch. EYLEA has already been approved for the treatment of visual impairment due to myopic choroidal neovascularization in Japan.

About Myopic Choroidal Neovascularization Myopic choroidal neovascularization (mCNV) is a disease of the retina in persons who are severely myopic (typically at least minus six diopters) and have pathological changes in the back of the eye. The disease is characterized by an abnormally elongated eye with a physical stretching of the sclera, choroid and retina, resulting in degenerative and progressive changes. These degenerative changes can induce the development of choroidal neovascularization. Anti-VEGF therapy has already been shown to be effective in the treatment of wet age-related macular degeneration (wet AMD), which is also characterized by an acute growth of new, abnormal blood vessels in the retina.

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 (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating closely on the global development of EYLEA. Regeneron has exclusive marketing rights for EYLEA in the USA. Bayer HealthCare has licensed the exclusive marketing rights outside the USA, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

Our online press service is just a click away: press.healthcare.bayer.com
Follow us on Facebook: www.facebook.com/healthcare.bayer
Follow us on Twitter: twitter.com/BayerHealthCare

Find more information at www.bayerpharma.com.

Forward-looking statements<br/>This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.