GNSC Genaissance Pharmaceuticals (MM)

Genaissance Study Sheds Light on Mechanism of Heart Disease Risk by Linking Genetic Variation to the Effect of Hormone Replacement Therapy on C-Reactive Protein Findings Add to Question of Risk-Benefit Ratio of Hormone Replacement Therapy NEW HAVEN, Conn., Jan. 24 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. (NASDAQ:GNSC), a leading developer and user of genetic information to help guide medical therapy, said a study it conducted on 674 subjects suggests that women with a genetic predisposition to protective levels of C-reactive protein (CRP) lose that benefit when taking hormone replacement therapy (HRT). The results of this study were published in the December 2004 issue of the journal Atherosclerosis. The study, a pioneering look at how genetic markers might be responsible for differential response to statin drugs for lowering cholesterol, found that women who were on HRT lost the protective benefits of certain genetic variants that would normally predispose them to lower levels of CRP, an established marker for fatal coronary disease. The results of this study are the first published result from Genaissance's STRENGTH (Statin Response Examined by Genetic Haplotype Markers) study, the largest prospective pharmacogenetic study ever undertaken to find genetic markers responsible for differential response to statin drugs for lowering cholesterol. The eight-month study of 315 men and 359 women also was designed to find genetic markers responsible for pre-treatment levels of important biomarkers such as low-density lipoprotein (LDL), high-density lipoprotein (HDL) and CRP. Several studies by leading academic/medical centers have shown that CRP levels may be more important than cholesterol levels for predicting cardiovascular events such as heart attacks. In particular, these studies have shown that elevated CRP is a risk factor that is independent of cholesterol levels. It had previously been shown that HRT caused elevated levels of CRP and of heart attacks and strokes (Women's Health Initiative). The current study shows that the protective effect of a key genetic variant may be overwhelmed by the use of these drugs. "The finding is a milestone in the field of pharmacogenetics because it shows how a widely used class of drugs and common genetic variants can interact, thereby determining risk for a widespread, life threatening disease," stated Richard Judson, Ph.D., Chief Scientific Officer of Genaissance. The results give lifestyle guidance to women who would like to preserve the protective benefits conferred by favorable genetic variations, and may ultimately lead to new or modified drugs. The study showed that men and women with common variants in the apolipoprotein E (APOE) gene on average have naturally lower levels of CRP. In the case of women, however, the study indicates that this beneficial effect may be largely neutralized by HRT, allowing CRP levels to potentially increase to dangerous levels. The study results are the second released by Genaissance in recent months that demonstrate an important role for the technology of pharmacogenetics in equipping healthcare professionals with information about the influence of genetic variations on the safety of widely prescribed medicines. Last month, the company reported the discovery of genetic markers that it believes predict who is at risk of developing clozapine-induced agranulocytosis, a life- threatening decrease of white blood cells that requires frequent blood testing. The company believes the findings may apply to other drugs that also affect white blood cell counts. 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 ability to detect associations between clinical outcomes and genetic variation, the ability to assess how genetic variation can affect drug response, efforts to build a drug candidate pipeline, the timing and outcome of its genetic testing programs and 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: Richard S. Judson, Ph.D., Chief Scientific Officer and Senior Vice President, R&D, +1-203-786-3617 , , or Matthew W. Kalnik, Ph.D., Senior Vice President, Business Development, +1-203-786-3588, , both of Genaissance Pharmaceuticals, Inc.; or Rhonda Chiger, investors, of Rx Communications, +1-917-322-2569, ; or Tom Redington, media, Redington, Inc. +1-203-222-7399, both for Genaissance Pharmaceuticals, Inc. Web site: http://www.genaissance.com/

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