Sequenom Licenses Worldwide Rights To Develop Age-Related Macular Degeneration Diagnostic Test

Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics;  Genetics;  Pharma Industry / Biotech Industry
Article Date: 10 Feb 2010 - 1:00 PDT

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Sequenom, Inc. (Nasdaq: SQNM), announced an exclusive worldwide licensing agreement with Optherion, Inc. Under the agreement, Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM), obtained the rights to develop and commercialize diagnostic tests to predict genetic predisposition to late stage age-related macular degeneration (AMD).

The license agreement covers extensive intellectual property rights for the most significant AMD-related genetic variants that have been confirmed in multiple clinical studies around the world. The portfolio of intellectual property being licensed has been consolidated from major US universities who have spearheaded genetic and clinical AMD research during the last decade.

Upon successful development of the test, Sequenom CMM intends to market a laboratory developed test under its SensiGene™ brand name for genetic tests. The laboratory anticipates launching the new test early in 2011.

"This opportunity is an excellent fit for Sequenom," said Ronald M. Lindsay, PhD, senior vice president of research and development at Sequenom. "The format of the assay that we plan to develop is optimal for our MassARRAY technology. Indeed, our platform has already been used in several of the key published studies that have firmly validated the link between AMD and the genetic variants that we expect to form the basis of our planned test. The addition of this licensed technology to our portfolio is an important step toward our aspiration to develop and commercialize a portfolio of meaningful proprietary genetic tests driven by unmet clinical needs."

Colin J. Foster, president and CEO of Optherion, said, "The licensing agreement with Sequenom adds significantly to our ability to push forward in developing both diagnostics and ultimately disease-modifying treatments for dry AMD. Our agreement with Sequenom not only gives us access to an exquisite platform, the MassARRAY system, but also could ultimately lead to companion diagnostics for our recombinant 'protective' human complement factor H protein therapeutic."

About AMD

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. The end stage of this condition, called neovascular or 'wet AMD', develops in 10 to 20% of all cases, causes profound loss of central vision and is the leading source of legal blindness in people over age 50 in the developed world. It is caused by abnormal growth of fragile and leaky blood vessels (choroidal neovascularization or 'CNV') in the macula (a small area where vision is keenest at the center of the retina) in response to chronic inflammatory stress.

Although no curative therapies for AMD exist today, treatments are available that help to slow the progression or even partially reverse vision loss, provided diagnosis is made in the initial stages of wet AMD. Since loss of visual acuity in one eye is compensated by the fellow eye, patients with advanced AMD run the risk of not being diagnosed until they develop irreversible loss of central vision. This apparent failure to diagnose AMD before the development of CNV can be attributed to the insufficient time intervals of routine screening exams for high risk individuals, and potentially the failure to catch all emerging CNV cases early enough in cases involving rapid progression of disease.

A predictive test that identifies patients at higher than average risk to progress to wet AMD, should improve clinical management by transforming surveillance protocols and improve therapeutic decision-making.

"Given the demographics of an aging US population driving an increased incidence of AMD, the ability to assess the genetic risk of disease progression will not only help steer our current management strategies but also accelerate the development of novel genetically guided therapeutics that could drastically reduce, or even eliminate, the devastating loss of vision that accompanies AMD," commented Michael J. Tolentino, MD, Center for Retina and Macular Disease, Winter Haven, FL. "Genetic information may also predict response to currently available therapies and may be useful in classifying patients who will respond favorably or unfavorably to current treatments for wet AMD."

Approximately 75% of disease risk is inherited and predominantly caused by variations in a handful of genes discovered over the last five years. Most of the affected genes have been identified in regulatory proteins contained within the alternative complement system involved in innate immunity. Sequenom's goal is to develop a simple non-invasive DNA test to be performed once, that will provide a clinician with genetic information specific to an individual's risk of progression to late stage CNV in order to optimize patient management to preserve vision.

A patient's knowledge about being at higher risk also makes it easier to take certain preventative steps such as no longer smoking, and switching to a healthier diet rich in vitamins, antioxidants, certain carotenoids, and omega-3 fatty acids. Smoking and diet are among the most important modifiable risk factors that have been proven in clinical studies to delay onset and progression of late stage disease.

Incidence of AMD

AMD affects 15-20 million people in the US, over 2.5 million people in Canada, and more than 50 million worldwide. In North America there are 2 million people with vision loss and more than 600,000 that are legally blind due to the disease. The worldwide incidence of the disease increases from 1 in 10 people over the age of 60 to more than 1 in 4 people over the age of 75. According to the AMD Alliance, macular degeneration is more common than Parkinson's disease, Alzheimer's disease, breast cancer and prostate cancer combined.

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets.

About Sequenom Center for Molecular Medicine

Sequenom Center for Molecular Medicine® (Sequenom CMM), a CAP accredited and CLIA-certified molecular diagnostics laboratory, is developing a full range of advanced prenatal diagnostics. Branded under the name SensiGene™, these genetic tests provide earlier patient management alternatives for obstetricians, geneticists and maternal fetal medicine specialists. Sequenom CMM is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.

Sequenom®, Sequenom Center for Molecular Medicine® and MassARRAY® are registered trademarks of Sequenom, Inc. SensiGene™ is a trademark of Sequenom, Inc.

About Optherion

Optherion, Inc. is a biotechnology company that is developing diagnostic and disease-modifying therapeutics for the management and treatment of early-stage age-related macular degeneration (AMD), atypical hemolytic uremic syndrome (aHUS), and other chronic diseases involving the alternative complement cascade.

Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's plans and ability to develop and commercialize diagnostic tests, including plans to develop and market a laboratory developed test, to predict genetic disposition to late stage age-related macular degeneration (AMD), the Company's anticipated launch of a laboratory developed test early in 2011, the format of the assay and other features of the Company's planned test, the Company's goal to develop and deliver to the market a portfolio of meaningful proprietary genetic tests driven by unmet clinical needs, the impact of the licensing agreement on Optherion's ability to develop diagnostics and causative treatments for AMD, the impact of a predictive test on clinical management and the development of therapeutics to reduce or eliminate loss of vision, the role of genetic information in predicting patient response to currently available therapies and the use of genetic information for patient classification, the Company's goal to develop a simple non-invasive DNA test to be performed once, that will provide a clinician with genetic information specific to an individual's risk of progression to late stage choroidal neovascularization in order to optimize patient management to preserve vision, and development of a full range of advanced prenatal diagnostics by Sequenom CMM, 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 research and development and commercialization of new technologies and products, particularly new technologies such as molecular diagnostics and laboratory developed tests, market demand for and acceptance and use by customers of new diagnostic or laboratory developed tests, the Company's financial position, the Company's ability to manage its existing cash resources or raise additional cash resources, ongoing litigation and investigations involving the Company, the Company's ability to position itself for product launches and growth, reliance upon the collaborative efforts of other parties, 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, and other risks detailed from time to time in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 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 the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Source: Sequenom, Inc

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