Healthcare Industry News: Age-related Macular Degeneration
News Release - January 17, 2014
Sequenom Laboratories grants Nicox exclusive promotion and marketing rights for its RetnaGene(TM) AMD test in North AmericaNicox further expands North American diagnostic portfolio with access to the RetnaGene AMD test, a genetic laboratory-developed test to predict the risk of progressing to late-stage or "wet" Age-related Macular Degeneration (AMD)
SOPHIA ANTIPOLIS, France and SAN DIEGO, Jan. 16, 2014 -- (Healthcare Sales & Marketing Network) -- Nicox S.A. (NYSE Euronext Paris: COX), and Sequenom, Inc. (SQNM), today announced that their affiliate companies (Nicox Inc. and Sequenom Laboratories) have entered into an exclusive agreement in the Age-related Macular Degeneration (AMD) field. As part of this agreement, Nicox has been granted the North American promotional rights to the Sequenom Laboratories RetnaGene™ AMD laboratory-developed test, for the evaluation of a patient's risk of AMD disease progression within 2, 5 and 10 years. The RetnaGene AMD test will be promoted by the same Nicox U.S. sales force which recently launched Sjo™, an advanced diagnostic panel for the early detection of Sjogren's Syndrome. Nicox expects to begin promoting the RetnaGene AMD test in the United States in the first half of 2014.
Jerry St. Peter, Executive Vice President and General Manager of Nicox Inc., said, "AMD affects approximately 15 million people in the United States and is a leading cause of vision loss in Americans aged 60 and over1. The ability to identify those patients most at risk of progressing to wet AMD represents a major opportunity to optimize the management of their disease. We are delighted to have formed this agreement with Sequenom Laboratories to market the RetnaGene AMD test, which fits perfectly within our diagnostics portfolio, and potentially other novel genetic tests in the future. With Sjo™, AdenoPlus® and now the RetnaGene AMD test, Nicox is further strengthening its position with ophthalmic diagnostics by continually bringing innovative tests to eye care professionals in North America."
"We are pleased to collaborate with Nicox to expand access to the RetnaGene AMD test to clinicians and their patients, and we are confident in Nicox's ability to leverage its growing sales team and expertise in the ophthalmic arena to successfully market the test," said William Welch, President and COO of Sequenom, Inc.
Terms of the agreement
Under the terms of the agreement, Sequenom Laboratories will grant Nicox exclusive rights to promote the RetnaGene AMD laboratory-developed test to eye care practitioners in North America (United States, Canada, Puerto Rico and Mexico) and co-exclusive rights towards specialized retina physicians. Sequenom Laboratories will provide the sample collection materials and will perform the testing in its CLIA-certified laboratory at an agreed price to Nicox. Further, Sequenom Laboratories will contribute existing commercial and clinical expertise, and marketing intelligence to expedite increased market demand and uptake within the general ophthalmology and optometry segments. Nicox will be responsible for all marketing and promotional activities, and will directly promote the RetnaGene AMD testing service to eye care practitioners.
The agreement also grants Nicox exclusive rights to an additional AMD laboratory-developed test currently in late-stage development and as well an exclusive option on further laboratory-developed tests developed by Sequenom Laboratories that are applicable in the ophthalmic space.
About the RetnaGene AMD test
The RetnaGene AMD test is a laboratory-developed test developed and validated exclusively by Sequenom Laboratories to evaluate the risk of early or intermediate Age-related Macular Degeneration (AMD) progressing to choroidal neovascularization (CNV), also known as wet AMD, within 2, 5 and 10 years. Wet AMD is characterized by abnormal growth and leakage of blood vessels in the macula, the center of the retina, leading to a loss of central vision.
The RetnaGene AMD test is an accurate, safe and noninvasive test that uses a DNA sample collected from a buccal (cheek) swab. The patient's risk of progressing to advanced choroidal neovascular disease within 2, 5 and 10 years is assessed based on four risk factors: genotype, phenotype (severity of the existing symptoms), age and environment (smoking status). Up to 70% of disease risk is inherited and predominantly caused by variations in a handful of genes discovered over the last 5 to 10 years. Most of the affected genes have been identified in regulatory proteins contained within the alternative complement system involved in innate immunity. Sequenom Laboratories' RetnaGene AMD test includes all of the major single nucleotide polymorphisms (SNPs) that have been proven to have the most significant effect on the risk of developing advanced AMD disease. The RetnaGene AMD test is the only test to date with 100% of SNPs validated using the Age Related Eye Disease Study (AREDS) patient samples, one of the largest clinical trials on AMD, which was sponsored by the National Eye Institute2. The results of the test will provide a clinician with an individual's risk score for progression to CNV, in order to optimize patient management with the goal of preserving vision.
About Age-related Macular Degeneration (AMD)
AMD is a progressive eye disorder which starts with small yellow deposits on the retina and can evolve in two different advanced forms called dry AMD and wet AMD. In the dry AMD form, geographic atrophy is considered the late stage of the disease. Wet AMD (also called neovascular AMD) is characterized by abnormal growth of fragile and leaky blood vessels, known as choroidal neovascularization in the macula (the small area at the center of the retina, where vision is keenest) in response to chronic inflammatory stress. Wet AMD causes profound loss of central vision and is a leading source of legal blindness in people over age 50 in the developed world. Late stage AMD represents 10 to 15% of all AMD cases and is estimated to affect at least 1.75 million patients in the US3.
1 Global prevalence of Age-related Macular Degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis, Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY, The Lancet Global Health, Early Online Publication 3 January 2014.
2 Inclusion of genotype with fundus phenotype improves accuracy of predicting choroidal neovascularization and geographic atrophy, Perlee LT, Bansal AT, Gehrs K, Heier JS, Csaky K, Allikmets R, Oeth P, Paladino T, Farkas DH, Rawlings PL, Hageman GS. Ophthalmology. 2013 Sep;120(9):1880-92
3 The prevalence of age-related eye diseases and visual impairment in aging: current estimates. Klein R, Klein BE. Invest Ophthalmol Vis Sci. 2013 Dec 13;54(14):ORSF5-ORSF13.
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. (SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
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 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 technologies.
SEQUENOM®, MaterniT21™ PLUS, SensiGene™, HerediT™, NextView™, 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 Nicox 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 2012 » filed with the French Autorite des Marches Financiers (AMF) on March 22, 2013 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 (including Sequenom, Inc. and Sequenom Laboratories) expectations regarding performance under, or the benefits or impact of the agreement with Nicox on Sequenom, physicians, patients, and healthcare, 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 reliance upon the collaborative efforts of Nicox, Sequenom and Sequenom Laboratories ability to develop and commercialize new technologies and products, particularly new technologies such as opthalmic, prenatal and other diagnostics and 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, government regulation particularly with respect to diagnostic products and laboratory-developed tests, obtaining or maintaining regulatory approvals, ongoing litigation including patent litigation, and other risks detailed from time to time in Sequenom, Inc.'s most recent Quarterly and Annual Reports on Securities and Exchange Commission Forms 10-Q and 10-K, respectively, 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.
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