BAYER SUBMITS EU MARKETING APPLICATION FOR VEGF TRAP-EYE (ENG)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
Not intended for U.S. and UK media
Bayer Submits VEGF Trap-Eye (aflibercept) for Treatment of Macular Edema
Following Central Retinal Vein Occlusion in EU 
Berlin, December 6, 2012 - Bayer HealthCare and Regeneron Pharmaceuticals,
Inc. today announced that Bayer HealthCare has submitted an application for
marketing authorization in Europe for VEGF Trap-Eye (aflibercept solution
for injection) for the treatment of macular edema following Central Retinal
Vein Occlusion (CRVO). VEGF Trap-Eye has already been approved under the
brand name EYLEA® in the United States, Europe, Japan, Australia, and in
several other countries for the treatment of wet age-related macular
degeneration (wAMD). 
"We are delighted to announce the filing for VEGF Trap-Eye for the
treatment of macular edema following CRVO indication with the European
Medicines Agency (EMA), so shortly after receiving approval for EYLEA for
the treatment of wet AMD," said Kemal Malik, M.D., member of the Bayer
HealthCare Executive Committee and Head of Global Development. "With the 52
week results of two Phase III trials showing substantial and sustained
improvement in vision relative to the sham control group, we are confident
that VEGF Trap-Eye has the potential to provide patients and physicians a
new treatment option for macular edema following CRVO." 
The submission of VEGF Trap-Eye for macular edema following CRVO is based
on data from the Phase III COPERNICUS and GALILEO studies. In both studies,
the primary efficacy endpoint was the proportion of patients who gained at
least 15 letters - measured on the Early Treatment Diabetic Retinopathy
Study (ETDRS) eye chart - of Best Corrected Visual Acuity (BCVA) at 24
weeks compared to baseline on the ETDRS visual acuity charts. The VEGF
Trap-Eye 2 milligrams (mg) monthly group was significantly superior to the
sham control group for the primary endpoint. The effects were largely
maintained until week 52. 
The week 52 results of the GALILEO and COPERNICUS studies demonstrated an
acceptable safety profile for VEGF Trap-Eye. 
EYLEA was approved in the United States for the treatment of wet AMD in
November 2011 and for macular edema following CRVO in September 2012. EYLEA
was also approved in Europe, Japan, Australia, and in several other
countries earlier this year for use in wet AMD. 
Phase III trials are currently under way with VEGF Trap-Eye in the
treatment of diabetic macular edema (DME) and myopic choroidal
neovascularization (mCNV). 
Bayer HealthCare and Regeneron are collaborating on the global development
of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye 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 VEGF Trap-Eye, except for Japan where
Regeneron will receive a royalty on net sales. 
About VEGF Trap-Eye (aflibercept solution for injection)
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 Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in
major European countries are estimated to suffer from CRVO. CRVO is caused
by obstruction of the central retinal vein that leads to a back up of blood
and fluid in the retina. The fluid can result in retinal injury and loss of
vision. VEGF levels are elevated in response to this retinal injury
contributing to macular edema. It is believed that anti-VEGF treatment may
help decrease vascular permeability and edema. 
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
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 http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2012-0521-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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