Exercises Right to Manufacture Vilazodone Under License Agreement with Merck KGaA of Darmstadt, Germany
Meets With FDA to Review Vilazodone Program and Manufacturing Plans
Clinical Data, Inc. (NASDAQ: CLDA) 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 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 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 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 filing related to both manufacturing processes and the clinical program. These goals were accomplished.
Vilazodone is a novel, dual serotonergic antidepressant. It is both a Selective Serotonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist. 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 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 - 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.
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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.
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