Bayer HealthCare and Regeneron Announce Regulatory Submission of EYLEA®
(aflibercept) Injection for the Treatment of Diabetic Macular Edema in Japan
TARRYTOWN, N.Y., March 3, 2014
TARRYTOWN, N.Y., March 3, 2014 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced that Bayer HealthCare's Japanese subsidiary,
Bayer Yakuhin, Ltd., has submitted an application for marketing authorization
for EYLEA^® (aflibercept) Injection for the treatment of patients with
diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and
"Clinically significant DME is a leading cause of vision loss in the
working-age population suffering from diabetes. With increasing rates of
diabetes worldwide, there continues to be a need for new treatment options,"
said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories. "We are pleased with this
regulatory submission and hope that if approved, EYLEA will provide a new
option for the treatment of DME in Japan."
The submission of EYLEA for DME in Japan is based on data from the VISTA-DME,
VIVID-DME and VIVID-Japan studies. In the Phase 3 VIVID-DME and VISTA-DME
trials, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two
months (after 5 initial monthly injections) achieved the primary endpoint of
significantly greater improvement in best-corrected visual acuity (BCVA) from
baseline compared to laser photocoagulation at 52 weeks. In these trials,
EYLEA was generally well tolerated with a similar overall incidence of adverse
events (AEs), ocular serious AEs, and non-ocular serious AEs across the
treatment groups and the laser control group. Arterial thromboembolic events
as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke,
non-fatal myocardial infarction, and vascular death) also occurred at similar
rates across the treatment groups and the laser control group. The most
frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and
VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous
floaters. The most frequent non-ocular TEAEs included hypertension and
nasopharyngitis, which occurred with similar frequency in the treatment groups
and the laser control group.
One-year data from the VIVID-DME and VISTA-DME trials have been presented at
medical congresses in the U.S. and Europe. Full two-year data from the
VISTA-DME trial will be presented at upcoming medical conferences. Two-year
data from the similarly designed VIVID-DME trial are expected later in 2014.
Each of the VISTA-DME and the VIVID-DME trials is expected to continue as
planned up to 148 weeks.
EYLEA was approved in the United States for the treatment of neovascular (wet)
Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema
following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has
also been approved in the European Union (EU) and other countries for use in
wet AMD and Macular Edema following CRVO. Regulatory submissions have also
been made in the U.S. and the EU for EYLEA for the treatment of DME. A
regulatory submission has been made in the U.S. for EYLEA for the treatment of
macular edema following Branch Retinal Vein Occlusion (BRVO).
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 share equally the profits from sales of EYLEA,
except for Japan where Regeneron receives a percentage of net sales.
About the EYLEA^® (aflibercept) Injection Phase 3 DME Program
The global 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 EYLEA 2 mg monthly, EYLEA 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 in the EYLEA groups was
adjunct laser treatment, and in the laser control group it was EYLEA 2 mg.
The primary efficacy endpoint of all three studies is the mean change in BCVA
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-DME studies are ongoing.
About Diabetic Macular Edema (DME)
DME is a common complication of Diabetic Retinopathy, 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 has been steadily climbing and
it is projected that up to seven percent of all patients with diabetes will
develop DME during their lifetime.
About EYLEA^® (aflibercept) Injection for Intravitreal 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, such as wet age-related macular
degeneration, it is also associated with the growth of abnormal new blood
vessels in the eye, which exhibit abnormal increased permeability that leads
to edema. Scarring and loss of fine-resolution central vision often results.
EYLEA, known in the scientific literature as 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 their cognate VEGF
IMPORTANT PRESCRIBING INFORMATION FOR EYLEA^® (aflibercept) INJECTION IN THE
EYLEA^® (aflibercept) Injection is indicated for the treatment of patients
with neovascular (Wet) Age-related Macular Degeneration (AMD). The
recommended dose for EYLEA is 2 mg administered by intravitreal injection
every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg
once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2
mg every 4 weeks (monthly), additional efficacy was not demonstrated when
EYLEA was dosed every 4 weeks compared to every 8 weeks.
EYLEA is indicated for the treatment of patients with Macular Edema following
Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 mg
administered by intravitreal injection every 4 weeks (monthly).
IMPORTANT SAFETY INFORMATION FOR EYLEA^® (aflibercept) INJECTION
EYLEA^® (aflibercept) Injection is contraindicated in patients with ocular or
periocular infections, active intraocular inflammation, or known
hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Intravitreal injections, including those with EYLEA, have been associated with
endophthalmitis and retinal detachments. Proper aseptic injection technique
must always be used when administering EYLEA. Patients should be instructed
to report any symptoms suggestive of endophthalmitis or retinal detachment
without delay and should be managed appropriately. Intraocular inflammation
has been reported with the use of EYLEA.
Acute increases in intraocular pressure have been seen within 60 minutes of
intravitreal injection, including with EYLEA. Sustained increases in
intraocular pressure have also been reported after repeated intravitreal
dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the
optic nerve head should be monitored and managed appropriately.
There is a potential risk of arterial thromboembolic events (ATEs) following
use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal
stroke, nonfatal myocardial infarction, or vascular death (including deaths of
unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD
studies in patients treated with EYLEA was 1.8% during the first year. The
incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in
patients treated with EYLEA compared with 1.4% in patients receiving sham
control during the first six months.
The most common adverse reactions (5% or more) noted in the U.S. prescribing
information for the approved indications of EYLEA were conjunctival
hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and
increased intraocular pressure.
Serious adverse reactions related to the injection procedure have occurred in
<0.1% of intravitreal injections with EYLEA including endophthalmitis,
traumatic cataract, increased intraocular pressure, and vitreous detachment.
Please see the full U.S. Prescribing Information for EYLEA at www.EYLEA.com
About the EYLEA^® (aflibercept) Injection Global Collaboration
Regeneron is collaborating with Bayer HealthCare on the global development of
EYLEA. EYLEA is currently approved for the treatment of wet AMD in
approximately 50 countries outside the U.S., including Japan and Australia and
countries in the EU. EYLEA has also been approved by the European Commission
and in Japan for the treatment of visual impairment due to Macular Edema
secondary to CRVO.
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 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.
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 Diabetic Macular Edema and in the
treatment of Macular Edema following Branch Retinal Vein Occlusion; 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.
Your Investor Relations Contact at Regeneron:
Manisha Narasimhan, Ph.D. Tel. 914.847.5126
Your Media Contact at Regeneron:
Sandy Sexton, Tel. 914.847.3358
SOURCE Regeneron Pharmaceuticals, Inc.
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