EYLEA® (aflibercept) Injection Recommended for Approval for the Treatment of
Visual Impairment due to Diabetic Macular Edema in the European Union
TARRYTOWN, N.Y., June 27, 2014
TARRYTOWN, N.Y., June 27, 2014 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced that EYLEA^® (aflibercept) Injection has been
recommended for approval by the European Committee for Medicinal Products for
Human Use (CHMP) for the treatment of visual impairment due to diabetic
macular edema (DME). The decision of the European Commission is expected in
the second half of 2014.
"Diabetes is a growing health concern worldwide and this milestone brings us
one step closer to being able to offer patients and physicians in the European
Union a new therapeutic option for the treatment of diabetic macular edema,"
said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories.
The European Union (EU) submission is based on positive data from the Phase 3
VIVID-DME and VISTA-DME 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) both 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
One-year data from the VIVID-DME and VISTA-DME trials and two-year data from
the VISTA-DME trial have been presented at medical congresses. 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 EU and other countries for use in wet AMD and
Macular Edema following CRVO. Regulatory submissions have been made in Japan,
Asia Pacific, Latin America and the U.S., for the treatment of Diabetic
Macular Edema. In Japan, EYLEA has been additionally submitted for approval to
regulators for the treatment of choroidal neovascularization secondary to
pathologic myopia (mCNV). Regulatory submissions have 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 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. The primary endpoint of
all 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-DME 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 EYLEA^® (aflibercept) Injection for Intravitreal Injection
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in
the body. In patients with diabetic macular edema (DME),
hyperglycemia-induced vascular dysfunction and hypoxia result in elevated
intraocular VEGF levels in the eye and resultant blood vessel permeability
that leads to macular edema, which can result in vision loss.
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 marketed for the treatment of wet AMD in over 50
countries outside the U.S., including Japan and Australia. Bayer HealthCare
has received a positive recommendation for approval by the European Committee
for Medicinal Products for Human Use (CHMP) for the treatment of visual
impairment due to Macular Edema secondary to Central Retinal Vein Occlusion
Regeneron maintains exclusive rights to EYLEA in the United States.
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 commercializes 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 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,"
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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, such as the EYLEA^® (aflibercept) Injection Phase 3
Diabetic Macular Edema program; 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;
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
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Sanofi and Bayer HealthCare, to be cancelled or terminated without any further
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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 fiscal year ended December 31, 2013 and its Form 10-Q
for the quarterly period ended March 31, 2014. 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.
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 www.bayer.com. The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.
Your Investor Relations Contact at Regeneron:
Manisha Narasimhan, Ph.D. Tel. 914.847.5126
Your Media Contact at Regeneron:
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Your Contact at Bayer:
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SOURCE Regeneron Pharmaceuticals, Inc.
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