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EYLEA® (aflibercept) Injection Approved For The Treatment of Macular Edema Following Central Retinal Vein Occlusion In Japan



  EYLEA® (aflibercept) Injection Approved For The Treatment of Macular Edema
              Following Central Retinal Vein Occlusion In Japan

PR Newswire

TARRYTOWN, N.Y., Nov. 22, 2013

TARRYTOWN, N.Y., Nov. 22, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced that EYLEA^® (aflibercept) Injection has
received approval for the treatment of Macular Edema Following Central Retinal
Vein Occlusion (CRVO) from the Japanese Ministry of Health, Labour and
Welfare.

"We are pleased with the approval of EYLEA in Japan in the macular edema
following CRVO indication, a significant cause of visual impairment in
adults," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories.  "This approval reflects
our commitment, along with our partner Bayer HealthCare, to bring EYLEA to
patients worldwide."

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.  EYLEA has
also been approved in the European Union (EU), Japan, Australia, and in
several other countries for use in wet AMD.  EYLEA has also been approved by
the European Commission for the treatment of visual impairment due to macular
edema following CRVO, as well as in selected countries in Asia and Latin
America.  Regulatory submissions have also been made in the U.S. and the EU
for EYLEA in Diabetic Macular Edema.

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 Central Retinal Vein Occlusion (CRVO)
Over 66,000 people in major European countries, more than 100,000 people in
the United States, and about 140,000 patients in Japan, over the age of 40 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 has been shown that anti-VEGF treatment may help
decrease vascular permeability and edema in the retina in patients with CRVO.

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, 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, 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. 

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 approved for the treatment of wet AMD in
approximately 50 countries outside the U.S., including Japan and Australia and
countries in the EU.  EYLEA has also been approved by the European Commission
for the treatment of visual impairment due to macular edema secondary to CRVO.

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, 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 54,900 employees (Dec
31, 2012) and is represented in more than 100 countries.  More information at
www.healthcare.bayer.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, including serious complications
or side effects in connection with the use of Regeneron's product candidates
in clinical trials; 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 Macular Edema following Central
Retinal Vein Occlusion; ongoing regulatory obligations and oversight impacting
Regeneron's research and clinical programs and business; 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 and commercial success 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 its Form 10-Q for the
quarterly period ended September 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.

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
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
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