Regeneron to Present Phase 3 Data for EYLEA® (aflibercept) Injection in Diabetic Macular Edema at Upcoming Retina Society

   Regeneron to Present Phase 3 Data for EYLEA® (aflibercept) Injection in
          Diabetic Macular Edema at Upcoming Retina Society Meeting

PR Newswire

TARRYTOWN, N.Y., Sept. 17, 2013

TARRYTOWN, N.Y., Sept. 17, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) today announced that detailed results from the Phase 3
VIVID and VISTA trials of EYLEA^® (aflibercept) Injection in Diabetic Macular
Edema (DME) will be presented at an oral session during the upcoming annual
meeting of the Retina Society to be held September 26-29 in Los Angeles,
United States. These data will be presented on Friday, September 27, at 4:51
PM PDT. Separately, these data are also scheduled to be presented at an oral
presentation on September 27, at 3:58 PM CEST, at the EURETINA Congress in
Hamburg, Germany.

Regeneron will host a webcast investor meeting on Saturday, September 28, at
7:00 AM PDT/10:00 AM EDT to discuss these data. The event will be webcast and
can be accessed at www.regeneron.com or by dialing in via the following
numbers: (888) 660-6127 (U.S. toll free) or (973) 890-8355 (international
dial-in).

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 CRVO in September 2012. EYLEA has also been approved in Europe,
Japan, Australia, and in several other countries for use in wet AMD and in
Europe and selected countries in South America for Macular Edema following
CRVO.

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 share equally the profits from sales of EYLEA,
except for Japan where Regeneron receives 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. In patients with
diabetic macular edema (DME), hyperglycemia-induced vascular dysfunction and
hypoxia result in elevated intraocular VEGF levels in the eye and resultant
blood vessel permeability that leads to macular edema, which can result in
vision loss.

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 their
cognate VEGF receptors. 

IMPORTANT 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.

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 with the 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) 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 U.S. 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 and countries in the
E.U.

Regeneron maintains exclusive rights to EYLEA in the United States.

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.

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. Words such as "anticipate," "expect," "intend,"
"plan," "believe," "seek," "estimate," variations of such words and similar
expressions are intended to identify such forward-looking statements, although
not all forward-looking statements contain these identifying words. 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 and new indications for marketed products, such as the
application of EYLEA^® (aflibercept) Injection in the treatment of Diabetic
Macular Edema; ongoing regulatory obligations and oversight and 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 June 30, 2013. The
reader is cautioned not to rely on any forward-looking statements made by
Regeneron. 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.

Your Investor Relations Contact at Regeneron:
Manisha Narasimhan, Ph.D. Tel. 914.847.5126
E-Mail: manisha.narasimhan@regeneron.com

Your Media Contact at Regeneron:
Sandy Sexton, Tel. 914.847.3358
E-Mail: sandra.sexton@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Website: http://www.regeneron.com
 
Press spacebar to pause and continue. Press esc to stop.