Regeneron and Bayer Initiate Phase 3 Trial of Eylea (aflibercept) Injection for the Treatment of Diabetic Macular Edema in Asia and Russia
TARRYTOWN, N.Y. and BERLIN, Feb. 19, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that they have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries. The companies are extending their global development program for EYLEA in DME after promising results in the global Phase 2 DME program.
"DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development. "With this new trial, we look forward to potentially bringing another treatment option to patients with DME in Asia and Russia."
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. In Japan EYLEA was approved for use in wet AMD in September 2012. EYLEA was also approved in Europe, Australia, and in several other countries for use in wet AMD last year.
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 sales.
About the Phase 3 DME Program
The VIVID EAST-DME study (VEGF Trap-Eye In Vision Impairment Due to
DME) has three treatment arms. In the first arm, patients will be
treated every month with 2 milligrams (mg) of EYLEA. In the second
arm, patients will be treated with 2mg of EYLEA every two months
after an initial phase of five monthly injections. In the third
arm, the comparator arm, patients will be treated with macular
laser photocoagulation. The primary endpoint is mean change in
visual acuity from baseline to week 52 as measured by the Early
Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard
chart used in research to measure visual acuity. All patients will
be followed for a maximum of one year.
The first Phase 3 trial of EYLEA in DME, named VIVID-DME, is being conducted in Europe and Japan by Bayer HealthCare and is fully enrolled. A second study led by Regeneron, named VISTA-DME, is being conducted in the United States and is fully enrolled as well.
About Diabetic Macular Edema (DME)
DME is the most prevalent cause of moderate vision loss in patients
with diabetes. DME is a common complication of Diabetic Retinopathy
(DR), a disease affecting the blood vessels of the retina.
Clinically significant DME is a leading cause of blindness in
younger adults (under 50). 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. 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.
Additional Phase 3 trials are currently underway with EYLEA in the treatment of myopic choroidal neovascularization (mCNV) in Asia and Macular Edema following Branch Retinal Vein Occlusion (BRVO) in United States, Canada and Japan.
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 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, rheumatoid arthritis,
and asthma. 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
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.
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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 the VIVID EAST-DME Study, 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 and drug candidates
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, 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.
Regeneron Contact:
Corporate Communications
Investor Relations
Peter Dworkin
Michael Aberman, M.D.
Tel: 1 (914) 847-7640
Tel: 1 (914) 847-7799
peter.dworkin@regeneron.com
michael.aberman@regeneron.com
Bayer Contact:
Doreen Schroeder, Tel. +49 30 468-11399
doreen.schroeder@bayer.com
Find more information at www.bayerpharma.com
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SOURCE Regeneron Pharmaceuticals, Inc.
Web Site: http://www.regeneron.com
Posted: February 2013
