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Clinical Data and Duke University in Pharmacogenomics Research and Commercialization Collaboration

Posted on: Friday, 12 May 2006, 09:07 CDT

Clinical Data to Non-exclusively Share STRENGTH Studies Data With Duke Researchers in Return for First Right to Negotiate Commercial Licenses

Clinical Data, Inc. (NASDAQ: CLDA), a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care, announced today that it has entered into a 5-year research collaboration agreement with the Institute for Genome Sciences & Policy (IGSP) at Duke University. Under terms of the agreement, Clinical Data's PGxHealth division will provide IGSP with non-exclusive, confidential access to its STRENGTH studies conducted to discover genetic variants associated with baseline lipid parameters and the response of these parameters to statins (used to treat elevated levels of cholesterol). In return, Clinical Data receives the right to evaluate the commercial potential of any findings derived from studies where either the STRENGTH clinical and/or genetic databases are utilized in IGSP studies. Should Clinical Data be interested in any such findings, the Company also receives first right to negotiate a commercial license relating to any and all of the findings.

Researchers at Duke IGSP are planning a series of studies to find and validate associations between genetic variants and responses to drugs used for dyslipidemia (or "hypercholesterolemia") in a family practice setting and are also carrying out similar studies in the areas of hypertension and asthma. Duke researchers, their staff and named collaborators will use PGxHealth's STRENGTH data to help plan, validate and analyze findings from these studies.

Carol Reed, M.D., Senior Vice President and Chief Medical Officer of Clinical Data, said, "We are very pleased to enter into this agreement with Duke IGSP, a true leader in medical innovations and genomic medicine. We expect that these new studies will deepen our understanding of how genetics plays a role in the efficacy of pharmaceutical products for hypercholesterolemia, potentially leading to improved efficacy and safety of treatments for these common chronic diseases."

David Goldstein, Ph.D., of Duke IGSP, said, "This collaboration provides Duke with powerful leads generated by Clinical Data to identify and evaluate gene variants that make a real difference to how to better treat patients with hypercholesterolemia. In addition, with Clinical Data's commercial footprint in this area, they make an ideal partner for us to advance genomics into medical practice. We are pleased to have reached this agreement in which patients and physicians, as well as both parties, have the potential for significant benefit."

Drew Fromkin, Executive Vice President of Clinical Data, said, "IGSP research will open up new commercialization opportunities derived both from our investment in STRENGTH and from the research expertise and strong scientific capabilities of the Duke University investigators. We are very excited about this opportunity, PGxHealth's role in advancing this research, and the relationship that has been established with Duke University and its leadership."

As previously announced, the Clinical Data STRENGTH studies involved evaluating the response of 679 patients to atorvastatin, pravastatin, simvastatin, lovastatin and cerivastatin; and genotyped approximately 175 genes. Approximately 700 additional patients were evaluated at baseline. Clinical Data researchers have completed SNP- and haplotype-based association analyses of response to statins as measured by changes in lipid parameters and for baseline variables.

About the Institute for Genome Sciences & Policy at Duke University

The Duke Institute for Genome Sciences & Policy conducts focused research in the areas of pharmacogenetics, genomic medicine, population genomics, evolutionary genomics, genome technology, computational biology, bioinformatics, genome ethics, law, and policy. Through interdisciplinary investigations, the IGSP uses genome sciences and policy together to understand and improve human health, life and experience. The IGSP partners with industry to develop and translate novel therapies and predictive biomarkers into clinical research and practice to optimize efficiency, effectiveness and success in bringing the right therapy to the right patient at the right time. For more information, go to www.genome.duke.edu.

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care. The Company, founded in 1972, is organized under three worldwide divisions segmented by service offerings and varying client constituents: PGxHealth(TM); Cogenics(TM); and Vital Diagnostics(TM). Clinical Data's Therapeutic Diagnostics(TM) division, PGxHealth, builds upon existing assets and know-how acquired from Genaissance Pharmaceuticals in the areas of genomics-based, genetic tests and therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth plans to develop and introduce novel Therapeutic Diagnostics in some instances in combination with new and existing therapeutics. Clinical Data's Pharmacogenomics and Molecular Services(TM) division, Cogenics, consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005, and Genome Express SA, acquired in 2006. Cogenics provides a comprehensive range of molecular and pharmacogenomics services to pharmaceutical, biotech, academia, agricultural, and government clients. These services are offered in both research and regulated environments and have applications across the lifecycle of pharmaceutical product development including pharmacovigilance requirements post-launch. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l. This division serves the clinical laboratory in the traditional in-vitro diagnostics market worldwide with a focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States. Clinical Data currently employs a staff of over 430. The Company is headquartered in Newton, Massachusetts with operations in Texas, Connecticut, RTP - North Carolina, Rhode Island, and California as well as internationally in the UK, France, the Netherlands, Italy and Australia. Furthermore, Clinical Data has numerous distribution, licensing, development and other collaborations with key partners.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to successfully integrate the operations, business, technology and intellectual property obtained in our recent acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q.

Source: Business Wire

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