BAYER GETS EU APPROVAL FOR EYLEA FOR AGE-RELATED MD (ENGLISH)

     (The following press release from Bayer HealthCare  was received by 
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News-Release 
Not intended for U.S. and UK Media
Bayer receives approval for EYLEA® in Europe for the Treatment of Wet
Age-Related Macular Degeneration
New treatment allows dosing every other month following three initial
monthly injections in wet AMD patients 
Berlin, November 27, 2012 - Bayer HealthCare announced today that EYLEA®
(aflibercept solution for injection), also known in the scientific
literature as VEGF Trap-Eye, has been approved by the European Commission
for the treatment of patients with neovascular (wet) age-related macular
degeneration (wet AMD) at a recommended dose of 2 milligrams (mg). EYLEA
treatment is initiated with one injection per month for three consecutive
doses, followed by one injection every two months. There is no requirement
for monitoring between injections. After the first 12 months of treatment
with EYLEA, the treatment interval may be extended based on visual and
anatomic outcomes. In this case the schedule for monitoring should be
determined by the treating physician and may be more frequent than the
schedule of injections. 
"The approval of EYLEA in Europe is great news for the increasing number of
patients suffering from wet AMD, a sight threatening eye condition," said
Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head
of Global Development. "Furthermore we are very pleased to announce already
that we will launch EYLEA in one of our biggest markets - Japan - very
soon. We are looking forward to providing this new treatment which allows
dosing every other month following three initial monthly injections in wet
AMD patients in Europe very soon as well." 
Beyond wet AMD, Phase III trials with VEGF Trap-Eye have been completed for
the treatment of Macular Edema following central retinal vein occlusion
(CRVO) and are currently under way in the treatment of diabetic macular
edema (DME) and myopic choroidal neovascularization (mCNV). Bayer plans to
submit VEGF Trap-Eye for marketing authorization in Macular Edema following
CRVO in Europe by the end of 2012. 
EYLEA is already approved in the United States in wet AMD and in Macular
Edema following CRVO. Bayer has already received approval for EYLEA for the
treatment of wet AMD in several markets, including Japan, Australia, and
some countries in Latin America earlier this year. Submissions have been
filed in this indication for marketing authorization in additional
countries worldwide. 
Bayer HealthCare and Regeneron 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 will share equally the profits from
any future sales of EYLEA, except for Japan where Regeneron will receive a
royalty on net sales. 
About EYLEA® (aflibercept solution for injection)
EYLEA 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, also known in the scientific literature as 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
their cognate VEGF receptors. EYLEA 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, if left untreated. 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 Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers,
invents, develops, manufactures, and commercializes medicines for the
treatment of serious medical conditions. Regeneron markets three products
in the United States, EYLEA® (aflibercept) Injection, ZALTRAP®
(ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST®
(rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized
with Sanofi. Phase 3 studies are in progress with EYLEA in two additional
indications and with product candidates sarilumab and REGN727. Regeneron
has active research and development programs in many disease areas,
including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Additional information and recent news releases are available on the
Regeneron web site at http://www.regeneron.com. 
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 17.2 billion (2011), 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 55,700 employees (Dec
31, 2011) and is represented in more than 100 countries. More information
at http://www.healthcare.bayer.com. 
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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
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company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Contact:
Bayer Pharma AG
Doreen Schröder, Tel. +49 30 468-11399
E-Mail: mailto:doreen.schroeder@bayer.com 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2012-0505-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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