Regeneron and Bayer Initiate Phase 3 Trial of EYLEA® (aflibercept) Injection for the Treatment of Diabetic Macular Edema in

 Regeneron and Bayer Initiate Phase 3 Trial of EYLEA® (aflibercept) Injection
        for the Treatment of Diabetic Macular Edema in Asia and Russia

PR Newswire

TARRYTOWN, N.Y. and BERLIN, Feb. 19, 2013

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

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

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).

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

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

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

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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 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            
Bayer Contact:
Doreen Schroeder, Tel. +49 30 468-11399
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SOURCE Regeneron Pharmaceuticals, Inc.

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