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Clinical Data Completes Vilazodone Manufacturing Technology Transfer Under License with Merck KGaA.


NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: CLDA CLDA California Lyme Disease Association ) today announced that it has completed the transfer of the manufacturing technology necessary to produce a commercial supply of vilazodone, its dual serotonergic se·ro·to·ner·gic or se·ro·to·ni·ner·gic
adj.
Activated by or capable of liberating serotonin, especially in transmitting nerve impulses.



serotonergic

containing or activated by serotonin.
 antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy.  currently in pivotal Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The company's wholly-owned subsidiary, Genaissance Pharmaceuticals, Inc., acquired the rights to develop and commercialize vilazodone from Merck KGaA This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article.  of Darmstadt, Germany in September 2004. Under the terms of the license agreement, the company was required to make a milestone payment to Merck for the transfer of the vilazodone manufacturing technology in Clinical Data Common Stock equivalent in value to [euro]1.25 million Euro. The milestone payment has been made through the issuance of an aggregate of 102,588 shares of Clinical Data Common Stock, 24,947 of which shares were issued at the time of the exercise of the company's right to transfer the manufacturing technology in August of this year, and 77,641 of which shares were issued on December 20, 2006, when the transfer was completed. All of the shares issued to Merck are unregistered but carry certain demand and incidental registration rights as provided under the license agreement. The company intends to conduct aspects of the manufacturing of the clinical development and commercial supply of vilazodone through a third party.

About Vilazodone

Vilazodone is a dual serotonergic antidepressant in pivotal Phase III clinical trials that Clinical Data is developing with a companion biomarker, which will act as a genetic-based, predictive screening tool to guide the use of this novel antidepressant. It is both a Selective Serotonin Reuptake Inhibitor selective serotonin reuptake inhibitor
n.
SSRI.


Selective serotonin reuptake inhibitor (SSRI)
A class of antidepressants that work by blocking the reabsorption of serotonin in the brain, raising the levels of
 and a 5HT1A partial agonist agonist /ag·o·nist/ (ag´ah-nist)
1. one involved in a struggle or competition.

2. agonistic muscle.

3.
 that has been found to have an acceptable safety profile for this stage of development. As approximately one-half of depressed patients do not achieve satisfactory results with current first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy.  options, Clinical Data hopes to develop a product that combines a genetic test with vilazodone, to assist physicians in matching patients with a treatment that is likely to work for that patient in the first instance. The rights to develop and commercialize vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004.

About Clinical Data, Inc.

Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and pharmacogenomics services to both research and regulated environments. Its Vital Diagnostics division offers in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin.  solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide.

SAFE HARBOR Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  OF 1995

This press release contains certain forward-looking information about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. 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 regarding: our ability to successfully integrate the operations, business, technology and intellectual property obtained in our 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. All of such statements are subject to certain risks and uncertainties, many 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 and whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether vilazodone will be successfully marketed if approved; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; our ability to achieve the expected synergies and operating efficiencies from all of our acquisitions; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended September 30, 2006, and our subsequent Current Reports on Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
 filed with the 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, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Internet Website: www.clda.com
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Dec 22, 2006
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