EYLEA® (aflibercept) Submitted for EU Marketing Authorization for
the Treatment of Macular Edema Following Central Retinal Vein
Occlusion
TARRYTOWN, N.Y. and
BERLIN, Dec. 6, 2012 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today
announced that Bayer HealthCare has submitted an application for
marketing authorization in Europe
for EYLEA (aflibercept) Injection for the treatment of macular
edema following Central Retinal Vein Occlusion (CRVO).
"It is our pleasure to announce the filing for EYLEA for the
macular edema following CRVO indication with the European
Regulatory Authority (EMA) immediately after receiving approval for
the treatment of wet age-related macular degeneration. We
hope this will extend the benefits of EYLEA as a new treatment
option to European patients with macular edema secondary to central
retinal vein occlusion," said Kemal
Malik, M.D., Head of Global Development and member of the
Bayer HealthCare Executive Committee. "With 52 weeks results
of two Phase 3 trials showing substantial and sustained improvement
in vision relative to the sham control group, EYLEA has the
potential to provide patients and physicians a new treatment option
for central retinal vein occlusion."
The submission of EYLEA for Macular Edema following CRVO is
based on data from the Phase 3 COPERNICUS and GALILEO studies.
In both studies, the primary efficacy endpoint was the
proportion of patients who gained at least 15 ETDRS letters of Best
Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on
the ETDRS visual acuity charts. The EYLEA 2 milligrams (mg)
monthly group was significantly superior to the sham control group
for the primary endpoint. The effects were largely maintained
until week 52.
EYLEA 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.
EYLEA was approved in the United
States for the treatment of wet AMD in November 2011 and for macular edema following
CRVO in September 2012. EYLEA
was also approved in Europe,
Japan, Australia, and in several other countries
earlier this year for use in wet AMD.
Phase 3 trials are currently under way with EYLEA in the
treatment of diabetic macular edema (DME), branch retinal vein
occlusion (BRVO), and myopic choroidal neovascularization
(mCNV).
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 will share equally the profits from any future sales
of EYLEA.
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. In
Central Retinal Vein Occlusion (CRVO), a blockage occurs in the
main blood vessel that transports deoxygenated blood away from the
retina. VEGF levels are elevated in response contributing to
macular edema.
EYLEA 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 these cognate
VEGF receptors. EYLEA is specially purified and contains
iso-osmotic buffer concentrations, allowing for injection into the
eye.
In the United States, EYLEA is
approved for the treatment of wet AMD and Macular Edema following
CRVO. Phase 3 trials are currently underway with EYLEA for
the treatment of diabetic macular edema (DME) and Macular Edema
following Branch Retinal Vein Occlusion (BRVO).
IMPORTANT U.S. PRESCRIBING INFORMATION FOR EYLEA®
(aflibercept) INJECTION
In the
United States, 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.
In the United States, EYLEA is
also 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 during the post approval 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) reported in
patients receiving 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 Prescribing Information at
www.EYLEA.com.
About Central Retinal Vein Occlusion
(CRVO)
Over 100,000 people in the
United States and more than 66,000 people in major European
countries are estimated to suffer from CRVO. CRVO is caused by
obstruction of the central retinal vein that leads to a back up of
blood and fluid in the retina. The fluid can result in
retinal injury and loss of vision. VEGF levels are elevated
in response to this retinal injury contributing to macular edema.
It is believed that anti-VEGF treatment may help decrease
vascular permeability and edema.
About Regeneron Pharmaceuticals
Regeneron is a fully
integrated biopharmaceutical company that discovers, invents,
develops, manufactures, and commercializes medicines for the
treatment of serious medical conditions. Regeneron markets
three products in the United
States, EYLEA® (aflibercept) Injection,
ZALTRAP® (ziv-aflibercept) Injection for Intravenous
Infusion, and ARCALYST® (rilonacept) Injection for
Subcutaneous Use, ZALTRAP is co-commercialized with
Sanofi. Phase 3 studies are in progress with EYLEA in two
additional indications and with product candidates, sarilumab and
REGN727. Regeneron has active research and development
programs in many disease areas, including ophthalmology,
inflammation, cancer, and hypercholesterolemia. Additional
information and recent news releases are available on the Regeneron
web site at 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 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is represented in more than 100
countries. More information at
www.healthcare.bayer.com.
Regeneron Forward Looking-Statement
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, 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 drug candidates, competing drugs that may be superior
to Regeneron's products and drug candidates, uncertainty of market
acceptance of Regeneron's products and drug candidates,
unanticipated expenses, the costs of developing, producing, and
selling products, the potential for any license or collaboration
agreement, including Regeneron's agreements with Sanofi and Bayer
HealthCare, to be canceled or terminated, 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,
2011 and its Form 10-Q for the quarter ended September 30, 2012. Regeneron does not
undertake any obligation to update publicly any forward-looking
statement, whether as a result of new information, future events,
or otherwise, unless required by law.
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.
Contact
Information:
|
Michael
Aberman, M.D.
|
Peter
Dworkin
|
Investor
Relations
|
Corporate
Communications
|
914.847.7799
|
914.847.7640
|
michael.aberman@regeneron.com
|
peter.dworkin@regeneron.com
|
SOURCE Regeneron Pharmaceuticals