Nicox and Sequenom announce the launch of expanded access to RetnaGene™ test
portfolio in the U.S.
SOPHIA ANTIPOLIS, France, and SAN DIEGO, June 19, 2014
SOPHIA ANTIPOLIS, France, and SAN DIEGO, June 19, 2014 /PRNewswire/ -- Nicox
S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, and
Sequenom, Inc. (NASDAQ:SQNM), a life sciences company providing innovative
genetic analysis solutions, today announced that Nicox's subsidiary, Nicox
Inc. is launching expanded access to Sequenom Laboratories' RetnaGene™
portfolio of laboratory-developed genetic tests in the United States (U.S.).
The RetnaGene portfolio includes RetnaGene AMD and RetnaGene LR, specialized
genetic tests, which assess an individual's risk for advanced age-related
macular degeneration (AMD).
"Expanding access to the RetnaGene portfolio of tests is an important
milestone in the progress of the Nicox Ophthalmic Diagnostics franchise in the
U.S.," commented Jerry St. Peter, Executive Vice President and General Manager
of Nicox Inc. "AMD is a leading cause of blindness in the U.S. and is
estimated to affect over 15 million Americans, including 10 to 15% suffering
from an advanced form of the disease.^1,2 The RetnaGene tests allow for
improved patient management, by examining the most relevant genetic markers
for a more accurate prediction of advanced AMD risk. Both the RetnaGene tests
and our groundbreaking test for the early detection of Sjogren's syndrome,
Sjo™, will be supported by our rapidly expanding specialist sales force."
RetnaGene™ – A portfolio of laboratory-developed tests that advances AMD risk
AMD is the most common cause of visual impairment and the leading cause of
blindness in the elderly population in the developed world. The RetnaGene
portfolio includes two laboratory-developed genetic tests performed
exclusively by Sequenom Laboratories that evaluate an individual's risk of
advanced AMD. The RetnaGene AMD test assesses the risk for wet AMD (also
called choroidal neovascularization, CNV) within two, five and ten years in
patients aged 55 and older with early or intermediate dry AMD. The RetnaGene™
LR test assesses the lifetime risk of advanced AMD (wet or dry) in patients
who have not been diagnosed with AMD, aged 55 and older and/or with a family
history of AMD. The RetnaGene tests evaluate genotype and other known risk
factors, giving a more complete assessment of a patient's individual risk for
developing advanced AMD than with current phenotype-based standards.
"Currently there is much debate in the medical community surrounding the best
way to incorporate genetic testing for AMD into clinical practice. Expanded
access to the RetnaGene tests will provide broader use and education to
clinicians about this important technology," said Quan Dong Nguyen, MD, MSc,
who holds the McGaw Memorial Endowed Chair in Ophthalmology and is the
Inaugural Director of the Truhlsen Eye Institute, University of Nebraska
In January 2014, Sequenom Laboratories granted Nicox Inc. exclusive promotion
and marketing rights for its RetnaGene tests. Nicox Inc. has significantly
strengthened its field force to support the expanded access of the RetnaGene
portfolio, which is now available to its customers in the U.S.
"We believe the new offering of the RetnaGene tests by Nicox will help to fuel
the momentum in the field while also developing enhanced opportunities for
clinical trials and research to continue to investigate the utility of genetic
testing services for AMD," said Diana Do, MD, Associate Professor of
Ophthalmology and Director of the Carl Camras Center for Innovative Clinical
Research in Ophthalmology at the Truhlsen Eye Institute, University of
Nebraska Medical Center.
Both RetnaGene tests offer a quick and simple method for collecting DNA
specimens with an easy-to-use in-office buccal swab. The RetnaGene tests were
developed, validated and are performed exclusively by Sequenom Laboratories
and are available through contract with Nicox. U.S. eye care practitioners can
obtain more information and order specimen collection materials for the
RetnaGene test by calling +1.855.MY.NICOX (+1.855.696.4269). Additional
information can be found on Nicox's new website specifically intended for a
U.S. audience: www.mynicox.com. The Nicox Inc. team will be available at the
Optometry's Meeting® (117th Annual AOA Congress & 44th Annual AOSA Conference)
being held from June 25 to 29, 2014 in Philadelphia, Pennsylvania, to discuss
its ophthalmic diagnostics offering, including RetnaGene™ and Sjo™ (booth
"We are pleased with the timely progress of our partnership with Nicox and we
are confident in Nicox's ability to successfully expand access to the
RetnaGene portfolio of tests in the ophthalmic arena in the U.S.," stated
William Welch, Chief Executive Officer of Sequenom, Inc.
About AMD, a leading cause of blindness in the U.S.
AMD is an insidious, progressive eye disorder that starts with relatively
harmless tiny yellow deposits on the retina (the light sensitive tissue in the
eye) and increases in prevalence and severity with age. It is estimated that
AMD currently affects approximately 15 million people in the United States and
is a leading cause of vision loss in Americans aged 60 and over.^1 Advanced
AMD represents 10 to 15 percent of all AMD cases and is estimated to affect at
least 1.75 million patients in the U.S.^2
Geographic atrophy is considered the advanced stage of the dry form of AMD.
Another advanced form of AMD is neovascular or 'wet AMD', which causes
profound loss of central vision and is the leading source of legal blindness
in people over age 50 in the developed world. Wet AMD is caused by abnormal
growth of fragile and leaky blood vessels, known as choroidal
neovascularization (CNV) in the macula (a small area where vision is keenest
at the center of the retina) in response to chronic inflammatory stress.
Genetics are highly influential in the development of AMD, with up to 71
percent of heritability for advanced AMD.^3 The advanced "wet" form of the
disease accounts for approximately 90 percent of severe vision loss associated
with the disease.^4,5 Conversion to wet AMD can be sudden, with vision loss
being rapid and severe. A missed conversion can lead to delayed therapeutic
intervention and the potential for irreversible central vision loss. On the
contrary, an early risk assessment may enable patients to benefit from a
personalized patient management plan with the goal of preserving vision.
Exclusive agreement between Nicox Inc. and Sequenom Laboratories for RetnaGene
Under the terms of the agreement signed in January 2014, Sequenom's affiliate
Sequenom Laboratories granted Nicox Inc. exclusive rights to promote the
RetnaGene AMD and RetnaGene LR laboratory-developed tests to eye care
practitioners in North America (United States, Canada, Puerto Rico and Mexico)
and co-exclusive rights towards specialized retina physicians. Sequenom
Laboratories provides the sample collection materials and performs the testing
exclusively in its CLIA-certified laboratory at an agreed price to Nicox.
Further, Sequenom Laboratories contributes existing commercial and clinical
expertise, and marketing intelligence to expedite increased market demand and
uptake within the general ophthalmology and optometry segments. Nicox is
responsible for all marketing and promotional activities, and is directly
promoting the RetnaGene tests to eye care practitioners.
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an emerging international
company focused on the ophthalmic market. With a heritage of innovative R&D,
business development and commercial expertise, the Nicox team is building a
diversified portfolio of therapies and diagnostic tools that can help people
to enhance their sight. The Company's commercial portfolio and near-term
pipeline already include several innovative diagnostic tests intended for eye
care professionals, as well as a range of eye care products. Nicox's key
proprietary asset in ophthalmology is latanoprostene bunod, a novel compound
based on Nicox's proprietary nitric oxide (NO)-donating R&D platform,
currently in Phase 3 clinical development in collaboration with Bausch + Lomb
for the potential treatment of glaucoma and ocular hypertension. Further
NO-donors are under development, notably through partners.
Nicox is headquartered in France, with research capabilities in Italy, a
growing commercial infrastructure in North America and in the major European
markets and an expanding international presence through partners. Nicox S.A.
is listed on Euronext Paris (Compartment B: Mid Caps). For more information on
Nicox or its products please visit www.nicox.com.
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to
improving healthcare through revolutionary genomic and genetic analysis
solutions. Sequenom develops innovative technology, products and diagnostic
tests that target and serve molecular diagnostic markets. Website:
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular
diagnostics laboratory, has developed a broad range of laboratory-developed
tests, with a focus on prenatal and ophthalmological diseases and conditions.
Branded under the names SensiGene®, MaterniT21™ PLUS, HerediT™, NextView™ and
RetnaGene™, these molecular genetic laboratory-developed tests, performed
exclusively by Sequenom Laboratories, provide early patient management
information for obstetricians, geneticists, maternal fetal medicine
specialists and ophthalmologists. Sequenom Laboratories is changing the
landscape in genetic disorder diagnostics using proprietary cutting edge
Sequenom®, MaterniT21™ PLUS, SensiGene®, HerediT™, NextView™, and RetnaGene™
are trademarks of Sequenom, Inc. All other trademarks and service marks are
the property of their respective owners.
This press release contains certain forward-looking statements. Although the
Company believes its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated
in the forward-looking statements.
Risks factors which are likely to have a material effect on Nicox's business
are presented in the 4th chapter of the < Document de reference, rapport
financier annuel et rapport de gestion 2013> filed with the French Autorite
des Marches Financiers (AMF) on April 2, 2014 and available on Nicox's website
(www.nicox.com) and on the AMF's website (www.amf-france.org).
Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Sequenom's, Nicox's, and
healthcare provider expectations related to expanded access to the RetnaGene
portfolio of tests and the impact, effects, and benefits of such tests on
Sequenom, Nicox, healthcare providers, and patients, Sequenom's and Nicox's
expectations regarding future performance under the agreement between Sequenom
and Nicox and the expected or potential benefits and impact of the agreement
on Sequenom, Nicox, healthcare providers and patients, Sequenom's commitment
to improving healthcare through revolutionary genomic and genetic analysis
solutions, and Sequenom Laboratories's changing the landscape in genetic
disorder diagnostics, are forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform Act of
1995. These forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including the risks and
uncertainties associated with market demand for and acceptance and use of
technology and tests such as the RetnaGene portfolio of tests, reliance upon
the collaborative efforts of other parties such as Nicox, healthcare providers
and others, Sequenom or other parties obtaining or maintaining regulatory
approvals that impact Sequenom's business, government regulation particularly
with respect to diagnostic products and laboratory developed tests,
publication processes, the performance of designed product enhancements,
Sequenom's ability to develop and commercialize technologies and products,
particularly new technologies such as laboratory developed tests, Sequenom's
financial position, the timing and amount of reimbursement that Sequenom
Laboratories receives from payors for its laboratory developed tests,
Sequenom's ability to manage its existing cash resources or raise additional
cash resources, competition, intellectual property protection and intellectual
property rights of others, litigation involving Sequenom, and other risks
detailed from time to time in Sequenom's most recently filed reports on Form
8-K, its most recently filed Quarterly Report on Form 10-Q and its Annual
Report on Form 10-K/A and 10-K for the year ended December 31, 2013, and other
documents subsequently filed with or furnished to the Securities and Exchange
Commission. These forward-looking statements are based on current information
that may change and you are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this press
release. All forward-looking statements are qualified in their entirety by
this cautionary statement, and Sequenom undertakes no obligation to revise or
update any forward-looking statement to reflect events or circumstances after
the issuance of this press release.
1. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular
degeneration and disease burden projection for 2020 and 2040: a systematic
review and meta-analysis. The Lancet Global Health 2014, 2(2): e106-e116.
2. Klein R, Klein BEK. The prevalence of age-related eye diseases and
visual impairment in aging: current estimates. Invest Ophthalmol Sci. 2013;
3. Seddon JM, Cote J, Page WF, et al. The US twin study of age-related
macular degeneration: relative roles of genetic and environmental influences.
Arch Ophthalmol. 2005; 123(3):321-327.
4. Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N
Engl J Med. 2008;358(24):2606-2617.
5. Ferris FL, Fine SL, Hyman L. Age-related macular degeneration and
blindness due to neovascular maculopathy. Arch Ophthalmol. 1984;
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SOURCE Sequenom Laboratories
Contact: Sequenom, Carolyn Beaver, Chief Financial Officer, Sequenom, Inc.,
858-202-9028, email@example.com; or Rachel Kennedy, Media
Contact, Chandler Chicco Agency, 858-449-9575,
firstname.lastname@example.org; or Nicox, Gavin Spencer, Executive Vice
President Corporate Development, +33 (0)4 97 24 53 00,
email@example.com, Media Relations, United States, Pascale
Communications, Mike Elofer, +1 484 620 6167, firstname.lastname@example.org,
United Kingdom, Jonathan Birt, +44 7860 361 746, email@example.com,
France, Caroline Courme, Communication Manager, +33 (0)4 97 24 53 43,
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