BAYER SUBMITS REGULATORY SUBMISSION OF EYLEA IN JAPAN (ENGLISH)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
Dear Newsletter Subscriber, 
The following news item has been released: 
Not intended for U.S. and UK Media
Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for
Treatment of Diabetic Macular Edema in Japan 
Berlin, March 3, 2014 - Bayer HealthCare today announced that Bayer
Yakuhin, Ltd., Osaka, Japan, has submitted an application for marketing
authorization for VEGF Trap-Eye (aflibercept solution for injection) for
the treatment of patients with diabetic macular edema (DME) to the Ministry
of Health, Labour and Welfare (MHLW) in Japan. 
"Clinically significant DME is a leading cause of vision loss in the
working age population suffering from diabetes. The number of patients
suffering from diabetes on a worldwide basis continues to increase, and
with it the need for new treatment options. Whatever a person`s age, vision
impairment impacts everyday tasks and has a detrimental effect on quality
of life", said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. "With this filing, we hope to
make a significant contribution towards alleviating the impact of this
disease for the future in Japan." 
The submission of VEGF Trap-Eye (aflibercept solution for injection) for
DME in Japan is based on data from VISTA-DME and VIVID-DME studies. In the
Phase 3 VIVID-DME and VISTA-DME trials, VEGF Trap-Eye 2 milligrams (mg)
dosed monthly and VEGF Trap-Eye 2 mg dosed every two months (after 5
initial monthly injections), achieved the primary endpoint of significantly
greater improvements in best-corrected visual acuity (BCVA) from baseline
compared to laser photocoagulation at 52 weeks. One-year data from the
VIVID-DME and VISTA-DME trials were already presented at medical congresses
in the U.S. and Europe. Both trials are planned to continue up to 148
weeks. 
VEGF Trap-Eye has been approved under the brand name EYLEA® in Europe,
Japan, Australia, the United States, 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 central retinal vein
occlusion (CRVO) as well as in Japan, in selected countries in Asia, Latin
America and the U.S. for the treatment of macular edema following CRVO.
Regulatory submissions have also been made in the EU, the U.S., and other
countries, for EYLEA for the treatment of Diabetic Macular Edema, and in
Japan additionally for the treatment of choroidal neovascularization
secondary to pathologic myopia (mCNV). 
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 percentage of net sales. 
About the Phase 3 DME Program
The Phase 3 DME program consists of three double-masked trials: VIVID-DME,
VISTA-DME, and VIVID-EAST, and one open label single arm safety trial in
Japanese patients (VIVID-Japan). All three double masked studies have three
treatment arms, where patients are randomized to receive either VEGF
Trap-Eye 2 mg monthly, VEGF Trap-Eye 2 mg every two months (after 5 initial
monthly injections), or the comparator treatment of laser photocoagulation.
Based on protocol specified criteria, patients were eligible to receive
rescue treatment from week 24 onwards. Rescue treatment was adjunct laser
treatment for both VEGF Trap-Eye arms and VEGF Trap-Eye 2mg for the laser
group. The primary endpoint of these three studies is the mean change in
best-corrected visual acuity from baseline, as measured on the Early
Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart
used in research to measure visual acuity. The VIVID-DME, VISTA-DME and
VIVID-EAST studies are ongoing. 
About Diabetic Macular Edema (DME)
DME is a common complication of Diabetic Retinopathy (DR), a disease
affecting the blood vessels of the retina. Clinically significant DME
occurs when fluid leaks into the center of the macula, the light-sensitive
part of the retina responsible for sharp, direct vision. Fluid in the
macula can cause severe vision loss or blindness. 
DME is the most frequent cause of blindness in young and mid-aged adults.
The treatable population for DME globally is estimated at about 6.2 million
people. According to the American Diabetes Association, over 18 million
Americans currently suffer from diabetes, and many more are at risk for
developing diabetes. The incidence of diabetes is steadily climbing and it
is projected that up to seven percent of all patients with diabetes will
develop DME during their lifetime. 
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. It is also associated with the growth of abnormal new
blood vessels in the eye, which exhibit abnormal increased permeability
that leads to edema. 
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 their cognate VEGF receptors. 
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in
Tarrytown, New York that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other
areas of high unmet medical need, including hypercholesterolemia, oncology,
rheumatoid arthritis, asthma, and atopic dermatitis. For additional
information about the company, please visit 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 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 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. 
Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks
and uncertainties relating to future events and the future performance of
Regeneron, and actual events or results may differ materially from these
forward-looking statements. Words such as "anticipate," "expect," "intend,"
"plan," "believe," "seek," "estimate," variations of such words and similar
expressions are intended to identify such forward-looking statements,
although not all forward-looking statements contain these identifying
words. These statements concern, and these risks and uncertainties include,
among others, the nature, timing, and possible success and therapeutic
applications of Regeneron's products, product candidates, and research and
clinical programs now underway or planned, including without limitation
EYLEA®(aflibercept) Injection; unforeseen safety issues resulting from the
administration of products and product candidates in patients, including
serious complications or side effects in connection with the use of
Regeneron’s product candidates in clinical trials; the likelihood and
timing of possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed products,
such as the application of EYLEA® (aflibercept) Injection in the treatment
of Macular Edema following Branch Retinal Vein Occlusion and in the
treatment of Diabetic Macular Edema; ongoing regulatory obligations and
oversight impacting Regeneron’s research and clinical programs and
business, including those relating to patient privacy; determinations by
regulatory and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or commercialize
Regeneron's products and product candidates; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success of
Regeneron's products and product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and product
candidates; coverage and reimbursement determinations by third-party
payers, including Medicare and Medicaid; unanticipated expenses; the costs
of developing, producing, and selling products; the ability of Regeneron to
meet any of its sales or other financial projections or guidance and
changes to the assumptions underlying those projections or guidance; the
potential for any license or collaboration agreement, including Regeneron's
agreements with Sanofi and Bayer HealthCare, to be cancelled or terminated
without any further product success; and risks associated with third party
intellectual property and pending or future litigation relating thereto. A
more complete description of these and other material risks can be found in
Regeneron's filings with the United States Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2013.
The reader is cautioned not to rely on any forward-looking statements made
by Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new information,
future events, or otherwise. 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2014-0070-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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