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Clinical Data and Quintiles Enter Strategic Alliance to Promote and Expand Clinical Data's Drug-Induced Long QT Pharmacogenomics Services

Posted on: Tuesday, 7 November 2006, 00:01 CST

Clinical Data, Inc. (NASDAQ: CLDA) and Quintiles Transnational Corp. today announced a strategic alliance to offer to Quintiles' customers CLDA's proprietary services related to the evaluation of drug-induced QT prolongation. The pharmacogenomics analyses are performed in the New Haven, CT, laboratories of Clinical Data's service division, Cogenics™. As part of the alliance, the two companies may also collaborate on the study of drug-induced QT prolongation for potential development of new products or services. This multi-year agreement will help sponsors and regulatory agencies further the understanding of the contribution of genetics to the QT-prolonging effects of drugs. Financial terms of the agreement were not disclosed.

Carol R. Reed, MD, Senior Vice President and Chief Medical Officer, commented, "We are very pleased to enter into this collaboration with Quintiles, a highly respected leader in providing clinical research services including expertise in the design and conduct of Thorough QT studies. Thorough QT (TQT) studies are designed to demonstrate the propensity of new molecular entities to cause prolongation of the QT interval on the ECG. This prolongation has been associated with fatal arrhythmias and has been the cause of the eventual withdrawal from the market of several otherwise efficacious compounds. This partnership will offer sponsors a unique spectrum of services to evaluate the contribution of genetics to QT prolongation and to comply with the recommendations of ICH guidelines which encourage genetic testing in conjunction with TQT trials."

Dhiraj Narula, MD, MRCP UK, FACC, Medical Director of Quintiles ECG Services, commented, "We believe that integration of genotype testing is essential to safety evaluation of molecules under development. Genotype testing holds great promise in helping us select or exclude subjects from clinical trials and in advancing our understanding of the genetic correlates of drug toxicity. It may also help revive the development of useful molecules with undesired effects on repolarization, by serving as a screening test for eligibility for therapy. We are excited about the potential for collaborative research with Clinical Data, Inc., a leader in the field of pharmacogenomic analyses, and about the opportunities this partnership offers to our sponsors."

About Long QT Testing Services

Drug-induced QT (DI-LQT) prolongation is a leading cause of delays in drug development and drug withdrawals from the market. Over the past few years, several drugs have been pulled from the market as a result of adverse effects related to cardiac safety. In response, regulatory agencies are requesting a definitive or Thorough QT (TQT) study prior to marketing approval. These studies are meant to prevent development expense by either confirming a drug's negligible effect on QT or identifying drugs that seriously impact QT at an early stage. In the event of a positive TQT, ICH E14 recommends that outliers be evaluated for risk factors including genotyping for LQTS to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome.

Clinical Data's Long QT Testing Services utilize intellectual property from CLDA's proprietary FAMILION test. The test is performed on blood and identifies mutations in people with inherited cardiac channelopathies by examining the sequences of five cardiac ion channel genes that have been shown to cause disorders.

About Quintiles Transnational Corp.

Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, information, financial partnering and commercialization for the pharmaceutical and biotechnology industries. With 16,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's Web site at www.Quintiles.com.

About Clinical Data, Inc.

Clinical Data, Inc., a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care, is organized under three worldwide divisions segmented by service offerings and varying client constituents: PGxHealth™; Cogenics™; and Vital Diagnostics™. The Pharmacogenomics and Molecular Services™ division, Cogenics, consolidates operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc., Icoria, Inc., and Genome Express SA to provide a comprehensive range of molecular biology and pharmacogenomics services to pharmaceutical, biotech, academic, 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. PGxHealth builds upon existing assets and know-how acquired from Genaissance Pharmaceuticals, Icoria, and Genome Express in the areas of genomics-based, genetic tests and therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth develops, validates and commercializes novel Therapeutic Diagnostics™, in some instances in combination with new and existing therapeutics, to improve patient care. In addition, PGxHealth has a therapeutic drug candidate, vilazodone, currently in late stage clinical trials for the treatment of depression. Vital Diagnostics 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 and 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 is headquartered in Newton, Mass. with operations in Texas, Connecticut, North Carolina, Rhode Island, and California as well as internationally in the UK, France, the Netherlands, Italy and Australia.

Please visit our website www.clda.com for more information.

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-K for the fiscal year ended March 31, 2006, and fiscal 2005, 2006, and 2007 quarterly reports on Forms 10-QSB and 10-Q.

Source: Business Wire

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