June 26, 2015
Not intended for U.S. and UK Media - Treatment of macular edema secondary to retinal vein occlusion (branch RVO or central RVO)

Bayer Receives Approval for EYLEA for the Treatment of Retinal Vein Occlusion in Japan

Berlin, June 26, 2015 - Bayer HealthCare has received approval from the
Ministry of Health, Labour and Welfare (MHLW) in Japan for EYLEA® (aflibercept
solution for injection) for the treatment of patients with macular edema
secondary to retinal vein occlusion (RVO). This new indication includes macular
edema secondary to branch retinal vein occlusion (BRVO) in addition to the
previously-approved indication of macular edema secondary to central retinal
vein occlusion (CRVO). Monthly administration of EYLEA is preferable until
visual acuity becomes stable. Dosing intervals of one month or longer are

"Especially in Japan, the retirement age tends to be rising due to declining
birthrates and aging population. The loss of even a single line of letters on
ETDRS eye chart may impact a patient's ability to work, and could mean they
leave the workforce early," said Dr. Joerg Moeller, Member of the Bayer
HealthCare Executive Committee and Head of Global Development. "Therefore it is
of utmost importance to have treatment options available which demonstrated in
clinical studies rapid and significant improvements in vision for RVO patients
regardless of disease severity."

RVO is a significant cause of vision impairment and a chronic disease that
requires early and ongoing management to obtain the best possible vision.

The approval is based on positive results from the double-masked, randomized,
active-controlled phase 3 VIBRANT study in patients with visual impairment due
to macular edema secondary to BRVO. The primary endpoint was the proportion of
subjects who gained at least 15 letters in best corrected visual acuity (BCVA)
from baseline at week 24, as measured on the Early Treatment Diabetic
Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to
measure visual acuity. More than half of the patients who were treated with
aflibercept solution for injection gained at least three lines (15 letters) of

About Retinal Vein Occlusion

Retinal vein occlusion (RVO) includes branch retinal vein occlusion (BRVO) and
central retinal vein occlusion (CRVO). RVO is a chronic eye condition that can
lead to sudden vision loss and is second only to diabetic retinopathy as the
most frequent cause of visual loss from diseases affecting the blood vessels of
the retina. While each patient experiences RVO differently, all patients are at
risk for vision loss which can impact their ability to participate in everyday
activities and may cause significant financial burden to patients, their
families as well as broader society. RVO has a significant global impact with
an estimated 16.4 million people affected worldwide, including around 13.9
million with BRVO and 2.5 million with CRVO. In Japan, it is estimated that
about 2.0% of people over the age of 40 are affected with RVO.

RVO is the result of a blockage in a blood vessel of the retina, the light
sensitive part of the eye. In CRVO, the blockage occurs in the main retinal
vein at the optic nerve. In BRVO, the blockage occurs in one of the branch
retinal veins. If a blockage in any of the retinal veins (central or branch) is
not resolved, it can result in a number of complications. The most common
reason for vision impairment in patients with RVO is macular edema, swelling of
the macula, which is the central portion of the retina responsible for seeing
fine details.

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.

Aflibercept solution for injection into the eye has been approved under the
brand name EYLEA® for the treatment of patients with neovascular age-related
macular degeneration (wet AMD), for the treatment of visual impairment due to
macular edema secondary to central retinal vein occlusion. EYLEA is also
approved for the treatment of diabetic macular edema (DME). In Europe and in
the U.S. EYLEA is already approved for the treatment of RVO (branch RVO or
central RVO). Over four million doses of EYLEA have been administered since
launch worldwide. In Japan, EYLEA has been additionally approved for the
treatment of myopic choroidal neovascularization.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the
global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in
the U.S. Bayer HealthCare 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.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. 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.

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Forward-looking statements

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