EYLEA® (aflibercept) Injection Approved for the Treatment of Wet Age-Related Macular Degeneration in Europe

 EYLEA® (aflibercept) Injection Approved for the Treatment of Wet Age-Related
                        Macular Degeneration in Europe

PR Newswire

TARRYTOWN, N.Y., Nov. 27, 2012

TARRYTOWN, N.Y., Nov. 27, 2012 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced that EYLEA^® (aflibercept) Injection has been
approved by the European Commission for the treatment of patients with
neovascular (wet) age-related macular degeneration (wet AMD). According to
the European Medicines Agency (EMA) approved Summary of Product
Characteristics, EYLEA treatment is initiated with one 2 milligram (mg)
injection per month for three consecutive months, followed by one injection
every two months. There is no requirement for monitoring by the physician
between injections. After the first twelve months of treatment with EYLEA,
the treatment interval may be extended based on visual and anatomic outcomes.
In such cases, the frequency of monitoring visits is determined by the
treating physician and may be more often than the schedule of injections. 

"We are pleased with the approval of EYLEA in the E.U.," said George D.
Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President
of Regeneron Laboratories. "We, along with our partner, Bayer HealthCare,
look forward to providing this new treatment option which will allow for every
other month dosing, following three initial monthly injections, to wet AMD
patients in the European Union."

EYLEA was approved for the treatment of neovascular (wet) AMD in the United
States in November 2011 andin Japan, Australia, Switzerland, and other
countries this year.Bayer HealthCare plans to launch EYLEA
inthesecountries later in 2012and into 2013.In the United States, EYLEA
was also approved for the treatment of Macular Edema following Central Retinal
Vein Occlusion (CRVO) in September 2012.

Bayer HealthCare and Regeneron are collaborating on the global development of
EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.
Bayer HealthCare has licensed the exclusive marketing rights outside the
United States, where the companies will share equally the profits from sales
of EYLEA, except for Japan where Regeneron will receive a royalty on net
sales.

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). Bayer HealthCare plans to
submit an application for marketing authorization in the CRVO indication in
Europe towards the end of 2012.

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 the EYLEA^® (aflibercept) Injection Global Collaboration
Regeneron is collaborating with Bayer HealthCare on the global development of
EYLEA. Some of the key markets where EYLEA has been approved for the
treatment of patients with wet AMD include Japan, Australia, Brazil and
Colombia.

Bayer HealthCare will market EYLEA 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.
Regeneron maintains exclusive rights to EYLEA in the United States.

About Wet AMD
Age-related macular degeneration (AMD) is a leading cause of acquired
blindness. Macular degeneration is diagnosed as either dry (non-exudative) or
wet (exudative). In wet AMD, new blood vessels grow beneath the retina and
leak blood and fluid. This leakage causes disruption and dysfunction of the
retina creating blind spots in central vision, and it can account for
blindness in wet AMD patients. Wet AMD is the leading cause of blindness for
people over the age of 65 in the U.S. and Europe.

About Central Retinal Vein Occlusion

Over 100,000 people in the United States 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. This causes retinal damage and loss of
vision. Release of vascular endothelial growth factor (VEGF) contributes to
increased vascular permeability in the eye and macular edema. It is believed
that anti-VEGF treatment may help decrease vascular permeability and edema in
the retina in patients with CRVO.

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.

Contact Information:
Manisha Narasimhan, Ph.D.              Peter Dworkin
Investor Relations  Corporate Communications
914.847.5126 914.847.7640
                                                      
manisha.narasimhan@regeneron.com               peter.dworkin@regeneron.com



SOURCE Regeneron Pharmaceuticals, Inc.

Website: http://www.regeneron.com
 
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