Printer Friendly
The Free Library
19,595,260 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Clinical Data's Vilazodone Patient Enrollment Over One Third Complete.


NEWTON, Mass. -- Clinical Data, Inc.

Exercises Right to Manufacture Vilazodone Under License Agreement with 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

Meets With FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 to Review Vilazodone Program and Manufacturing Plans

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 ) announced that over 150 patients have now been enrolled in the Company's Phase 3 clinical study of vilazodone for the treatment of depression. The trial is being conducted as a double-blind, placebo-controlled study designed to assess the safety and efficacy of vilazodone for the treatment of depression. The trial will enroll approximately 400 adult patients diagnosed with Major Depressive Disorder Major depressive disorder
A mood disorder characterized by profound feelings of sadness or despair.

Mentioned in: Conduct Disorder

major depressive disorder 
 at nine U.S. centers. As part of the trial, Clinical Data will also seek to discover genetic markers for response to vilazodone.

Separately, the Company announced that its wholly-owned subsidiary, Genaissance Pharmaceuticals, Inc., has exercised its contractual rights A contractual right is a claim, on other persons, that is acknowledged and perhaps reciprocated among the principals associated with that claim. Specialized contractual rights exist as part of a "contract" or agreement between persons to whom these rights belong.  with Merck KGaA of Darmstadt, Germany, to assume the manufacturing technology necessary to produce a commercial supply of vilazodone. Under the terms set forth in its September 2004 agreement with Merck KGaA, Genaissance's exercise of its right to manufacture vilazodone gives rise to a certain milestone payment to Merck KGaA, which will be paid in equity in Clinical Data equivalent in value to EUR EUR

In currencies, this is the abbreviation for the Euro.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 1.25 million Euro (or approximately US $1.60 million). At prevailing market prices, this would result in the issuance of approximately 136,750 shares of Clinical Data common stock. Such shares would be unregistered when issued and 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 through a third party.

Commenting on the news, Carol Reed, M.D., Clinical Data's Senior Vice President and Chief Medical Officer, said, "The vilazodone development program is continuing to progress in accordance with our planned timeline, with more than 150 of 400 patients now enrolled in this Phase 3 trial. We believe that our decision to exercise our right to manufacture vilazodone under our agreement with Merck KGaA is a key step in meeting our timeline and managing costs."

Separately, Clinical Data also announced today that it met voluntarily with representatives of the U.S. Food and Drug Administration (FDA) to discuss the status of its vilazodone development program, including its plans to manufacture vilazodone and to obtain agreement with FDA Staff on certain aspects of the requirements for NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  filing related to both manufacturing processes and the clinical program. These goals were accomplished.

About Vilazodone

Vilazodone is a novel, 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. . 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
 (SSRI SSRI selective serotonin reuptake inhibitor.

SSRI
n.
Selective serotonin reuptake inhibitor; a class of drugs that inhibit the reuptake of serotonin in the central nervous system, used to treat depression and other
) and a 5HT1A partial agonist agonist /ag·o·nist/ (ag´ah-nist)
1. one involved in a struggle or competition.

2. agonistic muscle.

3.
. The compound has been assessed in 15 phase 1 and five phase 2 trials involving a total of 369 healthy subjects and 1163 depressed patients. Vilazodone has been found to have an acceptable safety profile for this stage of development. In previous trials with positive controls, vilazodone failed to demonstrate significant efficacy against placebo but demonstrated efficacy comparable to that of the positive controls that are approved antidepressants Antidepressants
Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics
 in wide use. The rights to develop and commercialize vilazodone were acquired from Merck KGaA in September 2004.

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 (1) (Rapid Transport Protocol) The protocol used in IBM's High Performance Routing (HPR) system.

(2) (Realtime Transport Protocol) An IP protocol that supports real time transmission of voice and video.
 - North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures


Area, 52,586 sq mi (136,198 sq km). Pop.
, Rhode Island Rhode Island, island, United States
Rhode Island, island, 15 mi (24 km) long and 5 mi (8 km) wide, S R.I., at the entrance to Narragansett Bay. It is the largest island in the state, with steep cliffs and excellent beaches.
, 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 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 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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.

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.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Aug 17, 2006
Words:1236
Previous Article:Barnes & Noble Reports Second Quarter Financial Results: Achieves Earnings per Share Guidance; Declares Quarterly Dividend.
Next Article:C-COR Reports Financial Results for Fourth Quarter and Fiscal Year 2006.
Topics:



Related Articles
Guidant Completes Enrollment in International Drug Eluting Stent Clinical Trial; Data from Study Will Support Launch of XIENCE V Coronary Stent...
Guidant Enrolls First Patient in Japan Arm of Drug Eluting Stent Trial; SPIRIT III U.S. Randomized Enrollment Passes Halfway Mark.
Clinical Data Initiates Pivotal Phase III Trial for Novel Antidepressant; First Ever Pharmacogenomic Screening Tool for Antidepressant to be...
ImClone Systems Announces Complete Enrollment of Several Studies Examining Potential Survival Benefit Of ERBITUX(R) In Three Major Cancer Types.
Clinical Data Summarizes Progress and Achievements and Updates Strategy and Milestones; Company Successfully Integrating Molecular Services Assets,...
Clinical Data Initiates Patient Enrollment for Vilazodone Phase 3 Clinical Trial; Top-line Data Anticipated in Mid-2007.
Medtronic Announces Completion of Patient Enrollment in ENDEAVOR IV Clinical Trial; Enrollment Also Complete in ENDEAVOR-Japan and RESOLUTE Clinical...
Clinical Data Completes Vilazodone Manufacturing Technology Transfer Under License with Merck KGaA.
Clinical Data Announces Results for Fiscal Third Quarter 2007 Led by Revenue Growth and Continued Cash Management.
Clinical Data Completes Phase III Enrollment of Vilazodone for Depression.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles