GNSC Genaissance Pharmaceuticals (MM)

Genaissance Identifies Genetic Markers Implicated in Fatal Side Effects Of Schizophrenia Drug - Findings Underscore Role of Pharmacogenetics In Managing Safety Outcomes Of Drugs That Cause Serious Side Effects In Defined Populations - NEW HAVEN, Conn., Dec. 20 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. (NASDAQ:GNSC) today announced results from its CARING (Clozapine and Agranulocytosis Relationships Investigated by Genetics) study, reporting the discovery of genetic markers that the Company believes predict who is at risk of developing clozapine-induced agranulocytosis, a life-threatening decrease of white blood cells that requires frequent blood testing of patients. The Company said the findings may apply to other drugs that also affect white blood cell counts. "In light of recent drug withdrawals and labeling restrictions due to rare but serious adverse drug events, these results underscore the potential of pharmacogenetics to identify individuals who are at particular risk for developing fatal adverse drug reactions," said Kevin Rakin, President and Chief Executive Officer of Genaissance. "The CARING study is a powerful, cost-effective model for understanding the contribution of genetics to other adverse drug reactions and provides strong evidence of the power of Genaissance's proprietary platform. We believe an appreciable market exists for a genetic diagnostic test for predicting which patients are at-risk for developing agranulocytosis in response to clozapine and other drugs." "Our analyses indicate that genetic variation appears to explain a significant portion of the risk of developing clozapine-induced agranulocytosis," added Carol R. Reed, M.D., Vice President of Medical Affairs of Genaissance. "We believe the sensitivity and selectivity of these markers could support further development of a diagnostic test. Additionally, one of the associations we identified in the HLA (Human Leukocyte Antigen) complex has been previously reported to be associated with clozapine-induced agranulocytosis. Our results confirm this finding, building confidence that our novel findings will be validated in future studies." "Clozapine has long been accepted as one of the most effective medications for treating schizophrenia but has had limited utilization due to the risk of inducing agranulocytosis," said John Kane, M.D., Chairman of the Department of Psychiatry at The Zucker Hillside Hospital, Professor of Psychiatry at Albert Einstein College of Medicine, and co-Chair of the CARING Steering Committee. "These findings have moved us one step closer to realizing an alternative approach in the prescribing of clozapine where a one-time genetic test may someday alleviate the need for continuous blood monitoring for the majority of clozapine treated patients." Genaissance believes that these scientific findings have uncovered new clues to the underlying biological and physiologic mechanisms of drug-induced agranulocytosis and provide a starting point for elucidating a common mechanism across drugs from different classes that carry this rare but devastating side effect. Genaissance is preparing a patent application designed to protect its novel findings and will provide further details after its anticipated filing of this application with the United States Patent and Trademark Office. About Genaissance Genaissance Pharmaceuticals, Inc. is developing innovative products based on its proprietary pharmacogenomic technology and has a revenue-generating business in DNA and pharmacogenomic products and services. Genaissance also markets its proprietary FAMILION(TM) Test, designed to detect mutations responsible for causing Familial Long QT and Brugada Syndromes, two causes of sudden cardiac death. The Company's product development strategy is focused on drug candidates with promising clinical profiles and finding genetic markers to identify a responsive patient population. This strategy enables Genaissance to leverage existing clinical data and, thus, reduce the costs and risks associated with traditional drug development and increase the probability of clinical success and commercialization. The Company's lead therapeutic product, vilazodone for depression, is in Phase II of development. For more information on Genaissance, visit our website at: http://www.genaissance.com/ . This press release contains forward-looking statements, including statements about the expected growth and development of Genaissance's business, such as Genaissance's efforts to build a drug candidate pipeline, the timing and outcome of its genetic testing programs, the ability of Genaissance to apply its technologies to the development, marketing and prescribing of drugs and Genaissance's ability to detect associations between clinical outcomes and genetic variation. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to in such statements, including, but not limited to, the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety, the attraction of new business and strategic partners, the adoption of our technologies by the pharmaceutical industry, the acceptance of our cardiac tests by health care providers, the timing and success of clinical trials, competition from pharmaceutical, biotechnology and diagnostics companies, the strength of our intellectual property rights and those risks identified in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004, filed with the Securities and Exchange Commission on November 15, 2004, and in other filings we make with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein represent the judgment of Genaissance as of the date of this release. Genaissance disclaims any obligation to update any forward-looking statement. DATASOURCE: Genaissance Pharmaceuticals, Inc. CONTACT: Carol Reed, M.D., Vice President, Medical Affairs, +1-203-786-3617 or , or Matthew W. Kalnik, Ph.D., Senior Vice President, Business Development, +1-203-786-3588 or . both of Genaissance Pharmaceuticals, Inc.; or Rhonda Chiger (investors) of Rx Communications, +1-917-322-2569 or for Genaissance Web site: http://www.genaissance.com/

Copyright