EYLEA® (aflibercept) Injection Submitted for EU Marketing Authorization for
the Treatment of Diabetic Macular Edema
TARRYTOWN, N.Y., Nov. 7, 2013
TARRYTOWN, N.Y., Nov. 7, 2013 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has
submitted an application for marketing authorization in the European Union
(EU) for EYLEA^® (aflibercept) Injection for the treatment of patients with
Diabetic Macular Edema (DME). Regeneron has submitted a supplemental BLA for
EYLEA in this indication to the U.S. Food and Drug Administration (FDA).
"Diabetes is a growing, worldwide health concern and DME is a major cause of
vision loss in those with diabetic retinopathy," 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 in a third
indication for EYLEA in Europe and, if approved, hope to be able to offer
physicians and patients a new treatment option."
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 both trials have been
presented at medical conferences. The VISTA-DME and VIVID-DME trials are
planned to continue 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, Japan, Australia, and in several
other countries for use in wet AMD. EYLEA has also been approved by the
European Commission for the treatment of visual impairment due to macular
edema secondary to CRVO, as well as in selected countries in Asia and Latin
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 royalty on 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 (in Russia, China and other Asian countries),
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 milligrams (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.
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
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 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
for the treatment of visual impairment due to macular edema secondary to CRVO.
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 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 18.6 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 at
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; ongoing
regulatory obligations and oversight impacting Regeneron's research and
clinical programs and business; 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, 2012 and its Form 10-Q for the quarterly period ended September
30, 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.
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:
Sandy Sexton, Tel. 914.847.3358
SOURCE Regeneron Pharmaceuticals, Inc.
Press spacebar to pause and continue. Press esc to stop.