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U.S. FDA Approves EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration

Overview Eylea for the Treatment of Wet Age-Related Macular Degeneration

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Friday - November 18, 2011

Not intended for U.S. and UK Media

U.S. FDA Approves EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration

Approval based on positive results of VIEW 1 and VIEW 2 clinical trials / Regeneron Pharmaceuticals will market EYLEA™ in the U.S.

Berlin, November 18, 2011 – Bayer HealthCare's collaboration partner, Regeneron Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for EYLEA™ Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

"The approval of EYLEA™ is great news for patients in the U.S. suffering from wet AMD," said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer. "This is an important milestone that further fuels our commitment to bring this new treatment option to wet AMD patients globally."

The FDA approval of VEGF Trap-Eye is based upon the results of two Phase III clinical studies (VIEW 1 and VIEW 2) that demonstrated that VEGF Trap-Eye dosed every 8 weeks, following 3 initial injections every 4 weeks, showed comparable efficacy to Lucentis® (ranibizumab injection) dosed every 4 weeks, for the primary endpoint of maintenance of visual acuity (less than 15 letters of vision lost on an eye chart) over 52 weeks. The most common adverse reactions (>5%) reported in patients receiving VEGF Trap-Eye were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Beyond the wet AMD indication, Phase III trials are currently under way with VEGF Trap-Eye in the treatment of central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).

Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye. Bayer HealthCare owns the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

Bayer HealthCare has already submitted applications for marketing authorization in Europe, Japan, Australia and other countries for VEGF Trap-Eye for the treatment of wet AMD earlier this year.

About VEGF Trap-Eye

VEGF Trap-Eye 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. VEGF Trap-Eye acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (non-exudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), 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 and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

To learn more about Age-related macular degeneration (AMD), please visit: www.bayerpharma.de/en/AMD

Find more information at www.bayerpharma.com.

Forward-Looking Statements

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.

Eylea (VEGF Trap-Eye) for the Treatment of Wet Age-Related Macular Degeneration

News Age-Related Macular Degeneration