Regeneron and Bayer Report Positive Phase 3 Results for EYLEA® (aflibercept)
Injection in Myopic Choroidal Neovascularization (mCNV)
TARRYTOWN, N.Y., June 06, 2013
TARRYTOWN, N.Y., June 06, 2013 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Bayer HealthCare today announced positive top-line results
for EYLEA^® (aflibercept) Injection from the Phase 3 MYRROR study in myopic
choroidal neovascularization (mCNV). In this trial, patients receiving EYLEA
at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed
(PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA)
from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in
patients receiving sham injections (p<0.0001). The most common adverse events
observed in the MYRROR trial that occurred with a frequency of 2% or more were
conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis.
"Effective treatment options are urgently needed for patients with myopic
choroidal neovascularization (mCNV)," said Kemal Malik, M.D., member of the
Bayer HealthCare Executive Committee and Head of Global Development. "We are
pleased that the results of this study demonstrate that EYLEA may provide a
treatment option for these patients."
Data from this study will be presented at an upcoming medical conference.
Bayer HealthCare expects to submit the first application for regulatory
approval for this indication in Asia in the second half of 2013.
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. Outside of
the U.S., EYLEA has been approved for use in wet AMD in Japan, Australia,
Europe, and several other countries.
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, except for Japan where Regeneron will receive a royalty on net
About the Phase 3 MYRROR Trial
MYRROR was a double-masked, sham-controlled trial that randomized 122 patients
to receive either EYLEA 2 mg or sham. Patients in the active treatment arm
received one initial 2 mg dose of EYLEA. Patients were evaluated every 4
weeks and were eligible to receive additional EYLEA 2 mg intravitreal
injections on an as-needed (PRN) basis, determined by visual and anatomic
criteria, through 20 weeks. Patients in the sham arm received monthly sham
injections through week 20. Starting at week 24, patients in both arms were
eligible to receive EYLEA 2 mg on a PRN basis through week 44. The primary
endpoint of the study was the mean change at week 24 from baseline in
best-corrected visual acuity (BCVA) as measured on the Early Treatment
Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in
research to measure visual acuity.
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 myopic CNV, 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
receptors. EYLEA contains iso-osmotic buffer concentrations, allowing for
injection into the eye.
IMPORTANT PRESCRIBING INFORMATION FOR EYLEA^® (aflibercept) INJECTION
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 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%) 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 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 15
countries outside the U.S, including Japan and Australia. Bayer HealthCare
has submitted an application for marketing authorization in Europe for Macular
Edema following Central Retinal Vein Occlusion (CRVO).
Regeneron maintains exclusive rights to EYLEA in the United States.
About Myopic Choroidal Neovascularization
Myopic choroidal neovascularization is a disease of the retina where new,
abnormal blood vessels grow into the retina in persons who are severely myopic
(refractive error in excess of -6.00 Diopters). The disease is characterized
by an abnormally elongated eye with a physical stretching of the sclera,
choroid, and retina resulting in degenerative and progressive changes. These
degenerative changes can incite the development of choroidal
Severe myopia is particularly common in Asia. Myopic CNV is associated with
high degrees of myopia and leads to progressive vision loss. Myopic CNV has a
poor prognosis and, if left untreated, can within approximately 10 years
progress to legal blindness in a majority of patients. In East Asia, the
prevalence of myopia is significantly higher than in West Asia, and appears to
have an earlier onset. In Japan, mCNV is the second most common cause of
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 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 55,300 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. 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; 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 March 31, 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.
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:
Peter Dworkin, Tel. 914.847.7640
Your Contact at Bayer:
Doreen Schroeder, Tel. +49 30 468-11399
SOURCE Regeneron Pharmaceuticals, Inc.
Press spacebar to pause and continue. Press esc to stop.