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Genaissance allowed patent for method of testing individuals for genetic predisposition to reduced metabolism of drugs.

Genaissance Pharmaceuticals, Inc. (New Haven, CT), a leading developer and user of genetic information to help guide medical therapy, has received a notice of allowance from the United States 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 (United States Patent 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 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.

Genaissance Pharmaceuticals, Inc.

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Comment:Genaissance allowed patent for method of testing individuals for genetic predisposition to reduced metabolism of drugs.
Publication:BIOTECH Patent News
Geographic Code:1USA
Date:Mar 1, 2005
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