Sophia Antipolis, France, and San Diego, California, United States.

Nicox S.A. (NYSE Euronext Paris: COX), and Sequenom, Inc. (NASDAQ: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 Sjö™, an advanced diagnostic panel for the early detection of Sjögren’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 Sjö™, 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.

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References

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.