NEW HAVEN, Conn., March 11 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. , a leading developer and user of genetic information to help guide medical therapy, has received a notice of allowance from the U.S. Patent and Trademark Office. The allowed patent, which is co-owned with Duke University, claims testing for a common genetic variant in the CYP3A4 gene to predict poor metabolism of certain drugs. It is estimated at least 50 percent of all drugs, including chemotherapeutic agents and a wide variety of over-the-counter medications, are metabolized by the CYP3A4 enzyme. Individuals with a reduced ability to metabolize these drugs may be exposed to higher levels of the drug, placing them at risk for adverse drug reactions.
The allowed patent, "Methods for Evaluating the Ability to Metabolize Pharmaceuticals," describes the selection of chemotherapeutic agents based on the presence or absence of this variant, which is commonly called CYP3A4*1B. The patent also describes how a mutation in the GSTM1 gene affects drug metabolism.
In addition to the pharmacogenetic uses described above, the CYP3A4*1B variant may also be useful in identifying individuals at risk for prostate and breast cancer. An earlier related patent (U.S. 6,432,639: Isolated CYP3A4 Nucleic Acid Molecules and Detection Methods, which is solely owned by Genaissance) describes the discovery of the CYP3A4*1B variant and its detection.
"This is a significant addition to our intellectual property estate covering key drug-response markers because such a large number of important drugs are metabolized by CYP3A4," notes Kevin Rakin, President and Chief Executive Officer of Genaissance.
Mr. Rakin indicated the company's CYP3A4*1B assay technology may ultimately be incorporated in a simple DNA test that would provide potentially valuable prescribing information to physicians. "The clinical utility would be to appropriately dose medications that could cause harm if not fully metabolized, especially in the elderly or in cases where patients are receiving multiple drugs," he added.
Along with a wide variety of other clinical genetic assays for drug metabolism, Genaissance offers a CYP3A4*1B genotyping service. This service is used by major pharmaceutical companies in their drug development programs.
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 issuance of the patent covering the DecoGen(R) Informatics System, 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.
Genaissance Pharmaceuticals, Inc.
CONTACT: Richard S. Judson, Ph.D., Chief Scientific Officer, Senior VicePresident, R&D of Genaissance Pharmaceuticals, Inc., +1-203-726-3617,firstname.lastname@example.org; or Investors - Rhonda Chiger of Rx Communications,+1-917-322-2569, rchiger@RxIR.com; Media - Tom Redington of Redington, Inc.,+1-203-222-7399, email@example.com, both for GenaissancePharmaceuticals, Inc.