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Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for
Treatment of Diabetic Macular Edema in the EU
Berlin, November 7, 2013 - Bayer HealthCare has submitted an application
for marketing authorization of VEGF Trap-Eye (aflibercept solution for
injection) for the treatment of patients with diabetic macular edema (DME)
to the European Medicines Agency (EMA). Regeneron has submitted a
supplemental BLA (‘Biologics License Application’) for VEGF Trap-Eye in
this indication to the Food and Drug Administration (FDA).
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. and in selected countries in Asia and Latin America for the treatment
of macular edema following CRVO.
"The number of patients suffering from diabetes on a worldwide basis
continues to increase, and with it the need for new treatment options. DME
affects many patients, including those under the age of 50. Whatever a
person`s age, vision impairment impacts everyday tasks and has a
detrimental effect on quality of life", said Kemal Malik, M.D., Member of
the Bayer HealthCare Executive Committee and Head of Global Development.
"With this filing, Bayer and Regeneron hope to make a significant
contribution towards alleviating the impact of this disease in the future."
The submission of EYLEA for DME is based on data from the positive Phase 3
VISTA-DME and VIVID-DME studies. 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.
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 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-DME, 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.
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,
VIVID-EAST-DME, and VIVID-Japan 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, allergic asthma, and atopic dermatitis. For
additional information about the company, please visit
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
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Bayer 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. 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 for DME;
unforeseen safety issues resulting from the administration of products and
product candidates in patients; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage product
candidates; 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 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, 2012
and Form 10-Q for the quarter ended June 30, 2013. 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, unless
required by law.
Doreen Schröder, Tel. +49 30 468-11399
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