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Clinical Data Summarizes Progress and Achievements and Updates Strategy and Milestones

Posted on: Tuesday, 21 February 2006, 09:00 CST

Clinical Data, Inc. (NASDAQ: CLDA), a worldwide leader in commercializing pharmacogenomics to guide drug utilization, today reviewed recent achievements and is providing an update on strategy and anticipated operational milestones.

In 2005, Clinical Data completed a number of acquisitions that significantly enhanced the Company's breadth and depth of services provided to customers. In the process, the Company evolved from being solely a traditional diagnostics company providing lab equipment, reagents and support services to medium-size physician practices and smaller laboratories worldwide, to gaining a leadership position in molecular and pharmacogenomics services. The Company is also leveraging its extensive capabilities to develop Therapeutic Diagnostics(TM) that improve the efficacy and safety of drugs in development and optimize the use of therapeutics in specific patient populations. On a dual track, Clinical Data continues to expand its products and services in its Vital Diagnostics division, its diagnostics business.

Key Achievements - Vital Diagnostics

-- Acquired Electa Lab s.r.l. in December 2005 in an all-cash transaction valued at $1.8 million. Electa Lab, headquartered in Forli, Italy, is a leading worldwide supplier of Erythrocyte Sedimentation Rate ("ESR") instrumentation and related consumables with annual sales of more than $3 million. Electa Lab has also developed proprietary technology for the safe decapping of blood collection tubes and is developing instruments and assays for the immunochemistry and coagulation markets, areas highly complementary in nature to the diagnostic products already offered by Clinical Data's domestic and international subsidiaries;

-- Obtained exclusive distribution rights in the United States and Canada for a unique line of hematology analyzers and reagents developed by Melet Schloesing Laboratories that includes four fully automated differential blood cell analyzers for the human diagnostics market. Under the terms of this arrangement, Clinical Data may exclusively manufacture reagents for the analyzers. In August 2005, the Company announced that it received FDA 510(k) market clearance for the Excyte Pro-Diff 5 ("pro-Diff") hematology analyzer. Product launch occurred shortly after FDA clearance was received. In Q3, 2005, the Company shipped in excess of $100,000 worth of equipment to customers;

-- Launched the Envoy 500 benchtop chemistry analyzer in August 2005 leading to the highest quarterly equipment revenues achieved in the past 2 years;

-- Upgraded a majority of ESR analyzers to new (Electalab) ESR technology.

Key Achievements -Molecular and Pharmacogenomics Services

-- Acquired Genaissance Pharmaceuticals in October 2005 in an all-stock transaction valued at approximately $56 million. Genaissance is a leader in the promising areas of pharmacogenomics and molecular services. This acquisition provides a robust business in the target identification and drug development services markets focused on pharmaceutical, biotechnology, academia and government clients. The acquisition also launches Clinical Data into the clinical diagnostics market with unique Therapeutic Diagnostics driven by genetic marker discovery. Genaissance already has tests in the cardiovascular area with tests anticipated soon in CNS;

-- Acquired Icoria in December 2005 in an all-stock transaction valued at approximately $12.5 million. Icoria brings a valuable biomarker discovery platform as well as leading metabolomics and gene expression capabilities that complement the Company's molecular services and pharmacogenomics capabilities. Icoria also strengthens Clinical Data's position in RNA services and molecular profiling;

-- Received FDA approval in January 2006 for a pivotal Phase III study of Vilazodone, a novel compound being studied for treatment of depression. Clinical Data is now embarked on initiating the Phase III trial and parallel response biomarker discovery;

-- Signed deals with Organon, Otsuka and Sankyo to apply our know-how in biomarker development;

-- Accelerated validation of the CARING(TM) test development program that the Company expects will lead to the identification of biomarkers for clozapine-induced agranulocytosis;

-- Added Affymetrix based services that will enable our customers to access gene expression and whole genome array capabilities in a GLP-compliant environment;

-- Achieved significant growth in the adoption of the FAMILION(R) test, the Company's proprietary test for cardiac channelopathies including familial long QT and Brugada syndromes. The Company also signed its first deal with a pharmaceutical partner to utilize FAMILION in its clinical trials;

-- Received an NIAAA Second Phase SBIR contract for alcohol-induced injury biomarkers; three microarray services contracts for up to $1.1 million in revenue over 1-4 years for our microarray laboratory services unit; an NIEHS Second Phase SBIR $1.2 million for drug-induced liver injury; and a collaborative research agreement with the U.S. Army Edgewood Chemical Biological Center to participate in a study on chemical warfare agent detection.

Other Significant Achievements

-- Successfully phased up to the Nasdaq National Market in December 2005;

-- Completed $12 million private placement in November 2005 with a follow-on investment of $3.5 million received by the Company in February 2006 pursuant to the exercise of certain of the warrants issued in the private placement.

Key Goals and Milestones

-- Continue to integrate and expand the molecular and pharmacogenomics services business to provide broader product and service offerings;

-- Continue to build and expand the Vital Diagnostics business product line for physician practices and clinics;

-- Build a leadership position in molecular testing using pharmacogenomics in the clinical care setting. The Company expects to introduce Therapeutic Diagnostics and to have it emerge as a leader in this market through leveraging of the Company's intellectual property, existing test franchises in cardiovascular and CNS, and expertise in the areas of pharmacogenomics and marker discovery;

-- Begin to work with key constituents in the clinical and healthcare services markets to expand awareness of the Company's Therapeutic Diagnostics and related offerings;

-- Introduce new Therapeutic Diagnostics into the clinical setting (where clinicians incorporate these products as tools to help guide treatment/drug decisions in order to improve patient outcomes).

-- Capitalize on operational and other synergies from recent acquisitions;

-- Achieve further growth in Europe;

-- Complete enrollment of pivotal Phase III clinical trial for Vilazodone;

-- Report initial Phase III Vilazodone study by mid-2007;

-- File NDA for Vilazodone with FDA by as early as year-end 2008;

Clinical Data's President and CEO, Israel M. Stein, M.D., said, "Clinical Data has made significant progress in calendar 2005 including our bold strategic repositioning of the Company to take advantage of anticipated growth trends in targeted diagnostics and personalized medicine. We achieved key objectives in our Vital Diagnostics business and the companies we recently acquired each accomplished key objectives in their own right. We have summarized the collective major achievements of the Company's businesses and updated our goals to aid investors and clients in better understanding the focus and expertise of our business going forward."

Dr. Stein continued, "As we continue to integrate our molecular services assets and benefit from positive trends in our traditional diagnostics business, we look forward to accelerating our growth by capitalizing on the significant opportunities offered in our pharmacogenomics and diagnostics businesses."

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing molecular services and clinical diagnostics to improve patient care. Clinical Data's molecular services division is among the largest independent providers of pharmacogenomics and metabolomics services globally and consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. The division is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious therapeutics by finding genetic markers to guide drug development and utilization. These services are marketed to the pharmaceutical, biotech, clinical, academic, government and agricultural marketplaces. 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., which are each focused on the small volume clinical diagnostics market worldwide. Vital Diagnostics' instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has also achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States.

Therapeutic Diagnostics and CARING are trademarks, and FAMILION is a registered trademark of Clinical Data, Inc. ALL RIGHTS RESERVED.

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. 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 vilazodone will advance further in the clinical trials process; whether future clinical trials will warrant continued product development; whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; whether vilazodone will be successfully marketed; 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.

Internet Website: www.clda.com

Source: Business Wire

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