TARRYTOWN, N.Y., Jan. 13, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Geisinger Health System (Geisinger), one of the largest integrated health systems in the United States serving approximately 3 million residents, today announced a major research collaboration focused on studying the genetic determinants of human disease.
Beginning only ten years after the sequence of the first complete human genome was published, this new research collaboration will include one of the largest United States populations of participants for the analysis and sequencing of genetic material and comparison to long-term health outcomes.
During the initial five-year collaboration term, Geisinger plans to collect samples from more than 100,000 consented patient volunteers, while Regeneron, through its wholly-owned subsidiary, Regeneron Genetics Center LLC, will perform sequencing and genotyping to generate de-identified genomic data. The size and scope of the study are meant to allow great precision in identifying and validating the associations between genes and human disease.
"For Geisinger, this relationship is about the potential to improve individualized patient care," commented David H. Ledbetter, Ph.D., Executive Vice President and Chief Scientific Officer of Geisinger Health System. "We expect that many of our patients will directly benefit from their participation in this research because of Geisinger's ability to validate and return clinically actionable results to them, and all of our patients will benefit from the knowledge we gain in how to help set the standard for genomically informed care. This collaboration has the potential to provide Geisinger with tools to transform our ability to foresee disease before the onset of symptoms, diagnose chronic and potentially fatal conditions before it's too late to intervene, and determine how best to optimize the health and well-being for each of our patients."
"Genetics has been at the core of our research efforts at Regeneron since its early days," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer and President, Regeneron Laboratories. "In fact, our first FDA-approved therapy treats a rare genetic disorder, and the target of one of our product candidates in late stage development that acts to lower LDL cholesterol was identified using human genetics.1 With the tremendous recent advances in DNA sequencing, we believe that now is the time to increase our commitment to, and investment in, human genetics research. We believe that Geisinger is the best partner for addressing remaining limitations in making human genetic discoveries, and our proprietary VelociGene® and VelocImmune® technologies may provide the best way to advance these discoveries."
The collaboration will benefit from Geisinger's state of the art sample collection and storage capabilities, the MyCode™ biorepository, and extensive electronic medical records. Regeneron has built a team and an infrastructure to support sequencing and genotyping over the term of the collaboration. Regeneron intends to use its translational research and functional biology capabilities, including its VelociGene® technology, to validate observed human genetic associations.
"We are pleased to be embarking on this next generation human genetic sequencing project with Geisinger, a renowned integrated health care delivery system known for its innovation," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.
"Research is a core part of Geisinger's mission, and there is no more important medical research being done today than in genomics," added Glenn D. Steele, Jr., M.D., Ph.D., President and Chief Executive Officer of Geisinger Health System. "The combination of Geisinger and Regeneron brings together a unique set of assets and expertise that allow us to conduct research of this size and scope. I believe the long term benefits to human health and patient care will be tremendous."
About The Regeneron-Geisinger Genetic Research Collaboration Next-generation DNA sequencing technology is enabling genetic research on a larger scale than ever before. The Regeneron-Geisinger Genomics Sequencing Study is designed to leverage de-identified, clinical information and molecular data for medically relevant associations in a blinded fashion that preserves patients' privacy. The intent of the collaboration is to build a high-throughput platform for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs. For Regeneron, this collaboration is the first step in a planned expansion in the use of human genetics in the research process. For Geisinger, this collaboration is meant to further its ongoing mission to improve population health and individualized care through clinical innovation and cutting edge, world-class research.
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 Geisinger Health System Geisinger Health System is an integrated health services organization widely recognized for its innovative use of the electronic health record and the development of innovative care models such as ProvenHealth Navigator® and ProvenCare® . As the nation's largest rural health services organization, GHS serves more than 3 million residents throughout 44 counties in central and northeastern Pennsylvania. The physician-led system is comprised of more than 20,800 employees, including a 1,100-member multi-specialty group practice, seven hospital campuses, two research centers and a 448,000-member health plan, all of which yield an estimated $6.1 billion positive impact on the Pennsylvania economy. The health system and the health plan have repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, GHS has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or follow the latest GHS news and more on Twitter and Facebook.
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 the planned genetic research collaboration with Geisinger Health System, Regeneron's translational research and functional biology capabilities, and the planned expansion in the use of human genetics in Regeneron's research process; unforeseen safety issues resulting from the administration of products and product candidates in patients; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates; ongoing regulatory obligations and oversight impacting Regeneron's research and clinical programs and business, including those relating to patient privacy; 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 quarter 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.
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1 Cohen JC. N Engl J Med 2006;354:1264-72
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