January 23, 2015

Not intended for U.S. and UK Media

Bayer Receives Recommendation for Approval for New Treatment Option with Aflibercept Solution for Injection in EU

CHMP recommends EU approval for the treatment of visual impairment due to Macular Edema Secondary to Retinal Vein Occlusion
Berlin, January 23, 2015 - Bayer HealthCare today announced that aflibercept
solution for injection into the eye has been recommended for approval by the
European Committee for Medicinal Products for Human Use (CHMP) for the
treatment of patients with visual impairment due to macular edema secondary to
retinal vein occlusion (RVO), which includes Macular Edema following Branch
Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication
of Macular Edema secondary to Central Retinal Vein Occlusion (CRVO).

"Retinal vein occlusion is a common retinal vascular disorder with an estimated
16.4 million people affected worldwide, and it is a severe disease which is
potentially blinding if not treated early and appropriately," said Dr. Joerg
Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global
Development. "Vision impairment and blindness impact not only patients through
loss of independence, but also their families. Therefore, we hope to be able to
offer patients suffering from vision impairment secondary to BRVO and their
physicians this new treatment option shortly."

The positive CHMP recommendation is based on positive results from the
double-masked, randomized, active-controlled phase 3 VIBRANT study in patients
impacted by 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 of vision.

The previously approved indication of Macular Edema secondary to CRVO was based
on data from the Phase 3 COPERNICUS and GALILEO studies. In both studies, the
primary efficacy endpoint was the proportion of patients who gained at least 15
ETDRS letters of BCVA at 24 weeks compared to baseline on the ETDRS visual
acuity charts.

About the Phase 3 VIBRANT Study

VIBRANT was a Phase 3, randomized, double-masked, active-controlled 52-week
study, comparing aflibercept solution for injection 2 milligram (mg) monthly
with laser photocoagulation in subjects with macular edema secondary to BRVO.
At week 24, the primary endpoint of the study, 53% of patients who received
aflibercept solution for injection 2 mg monthly gained at least 15 letters
(equivalent to three lines) in best corrected visual acuity (BCVA) from
baseline, compared to 27% of patients who received laser (p<0.001). In
addition, aflibercept solution for injection met a key secondary endpoint,
achieving a 17.0 letter mean improvement over baseline in BCVA compared to a
6.9 letter mean improvement in patients who received laser (p<0.0001).

Aflibercept solution for injection into the eye was generally well tolerated.
Through week 24, the most common ocular adverse events in patients treated with
aflibercept solution for injection were conjunctival hemorrhage and eye pain.
The incidence of serious adverse events (SAE) was 9.9% in the aflibercept
solution for injection group and 9.8% in the laser group. Up to week 24, one
death and one Anti-Platelet Trialists' Collaboration (APTC) defined event
(non-fatal stroke) occurred during the trial, both events occurred in patients
in the laser group. There were no cases of intraocular inflammation. There was
one ocular SAE in a patient in the aflibercept solution for injection group,
which was a traumatic cataract.

About Retinal Vein Occlusion

Retinal Vein Occlusion (RVO) includes Branch Retinal Vein Occlusion (BRVO) and
Central Retinal Vein Occlusion (CRVO). 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. RVO is the result of a blockage in
a blood vessel of the retina, the light sensitive part of the eye responsible
for seeing fine details. In CRVO, the blockage occurs in the main retinal vein
at the optic nerve. In BRVO, the blockage occurs in one of the branches of the
main retinal vein. If a blockage of 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, which describes
swelling of the macula, which is the central portion of the retina.

About VEGF and 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® in more than 80 countries for the treatment of patients with
neovascular age-related macular degeneration (wet AMD) and around 60 countries
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 over 40 countries. Over three million doses of
EYLEA have been administered since launch worldwide. In Japan, EYLEA has been
additionally approved for the treatment of myopic choroidal neovascularization
and an application for marketing authorization has also been submitted for the
treatment of macular edema secondary to BRVO. In the U.S., EYLEA is already
approved for the treatment of BRVO.

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 EUR 18.9 billion (2013), 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 56,000 employees (Dec 31, 2013) and is
represented in more than 100 countries. More information is available at

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