November 28, 2013
Not intended for U.S. and UK Media - Myopic Choroidal Neovascularization:

Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for the Treatment of Myopic Choroidal Neovascularization in Japan

Berlin, November 28, 2013 - Bayer HealthCare has submitted VEGF Trap-Eye
(aflibercept solution for injection) for the treatment of myopic choroidal
neovascularization (myopic CNV) for regulatory approval in Japan. In Japan,
pathologic myopia and the associated myopic CNV is one of the most common
causes of blindness.

"Pathologic myopia, which develops various lesions affecting the back of the
eye such as myopic CNV, impacts a significant number of patients in Japan,"
said Professor Tatsuro Ishibashi, M.D., Department of Ophthalmology, Faculty of
Medicine, Kyushu University and Coordinating Investigator of the Phase 3 MYRROR
study. "A treatment option that could not only prevent permanent vision loss
but could also improve visual acuity would have great benefits for patients
with pathologic myopia."

"Unfortunately, mCNV has a poor prognosis and there are more treatment options
needed to address this urgent medical need for these patients, many of whom are
of working age," said Kemal Malik, M.D., Member of the Bayer HealthCare
Executive Committee and Head of Global Development. "We hope to be able to
bring VEGF Trap-Eye to patients and the ophthalmology community in Japan soon
to improve the prognosis of this vision-threatening condition."

The regulatory submission is based on positive data from the Phase 3 MYRROR
study in mCNV. The topline results were announced earlier this year with more
detailed data presented at the recent American Academy of Ophthalmology
Congress in New Orleans.

VEGF Trap-Eye has been approved under the brand name EYLEA® in Europe, the
United States, Japan, Australia, and in many other countries for the treatment
of patients with neovascular age-related macular degeneration (wet AMD). EYLEA
has also been approved in Europe for the treatment of visual impairment due to
macular edema secondary to CRVO as well as in the U.S., Japan and in several
countries in Asia and Latin America for the treatment of macular edema
following CRVO.

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

About mCNV
"Myopic choroidal neovascularization" is a disease of the retina where new,
abnormal blood vessels grow into the retina in persons who are severely myopic
(typically more than 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 incite the
development of choroidal neovascularization. Anti-VEGF treatment has been shown
to be effective in wet age related macular degeneration (wet AMD), which is
also characterised by an acute growth of new, abnormal blood vessels in the

Severe myopia is particularly common in Asia. Myopic CNV is associated with
high degrees of myopia and leads to progressive vision loss. Myopic CNV has a
poor prognosis and, if left untreated, can, within approximately 10 years,
progress to legal blindness in a majority of patients. In East Asia, the
prevalence of myopia is significantly higher than in West Asia, and appears to
have an earlier onset. In Japan, pathologic myopia is the second most common
cause of blindness.

About VEGF and VEGF Trap-Eye (aflibercept solution for injection)
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. However, in certain diseases, it is associated with the growth of
abnormal new blood vessels in the eye, which exhibit abnormal increased
permeability that leads to edema in certain diseases of the retina.

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.
EYLEA 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.

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 18.6 billion (2012), 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 54,900 employees (Dec 31, 2012) and is
represented in more than 100 countries. More information at

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