NEW HAVEN, Conn., Jan. 26 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. , a leading developer and user of genetic information to help guide medical therapy, expanded its ability to provide genetic tests for critical variants of key cardiac ion channel proteins involved in drug-induced cardiac arrhythmias. Drug-induced cardiac arrhythmias that are associated with prolongation of the QT interval on the electrocardiogram have led to the withdrawal from the market of such well- known drugs as the heartburn agent Propulsid(R) and the antihistamine Seldane(R).
Vanderbilt University has granted Genaissance exclusive commercial rights to U.S. Patent 6,458,542, which claims screening patients for susceptibility for drug-induced cardiac arrhythmias by testing for the presence of a common polymorphism in KCNE1, an important cardiac ion-channel gene.
"We chose Genaissance to commercialize this patented method because of its proven capability in developing a genetic test for Long QT syndrome, the FAMILION(TM) Test, and its reputation as a leader in pharmacogenetics," said Chris McKinney, Director of the Office of Technology Transfer and Enterprise Development at Vanderbilt University.
"Gaining the right to screen patients for this KCNE1 polymorphism, which increases a patient's risk of developing a drug-induced arrhythmia, is an important addition to our suite of patents with claims for testing for causes of Long QT. This is especially critical for FDA-mandated thorough QT safety trials that now occur in early stages of drug development," stated Richard Judson, Ph.D., Chief Scientific Officer of Genaissance.
"The Vanderbilt license adds a solid component to our clinical trial capabilities, giving us one of the industry's strongest and most complete pharmacogenetics programs for drug-induced QT prolongation," noted Kevin Rakin, President and CEO of Genaissance. "We are very pleased with the prospects for drug development collaborations with pharmaceutical companies in this area, and we would expect the tempo to accelerate once the FDA issues guidelines for pharmacogenomic data submissions."
The patent licensed from Vanderbilt University adds to Genaissance's extensive patent estate for genes associated with Long QT syndrome (LQTS). Episodic cardiac arrhythmia is a cause of sudden death and characteristic of LQTS. LQTS can be inherited (familial) or acquired, as in drug-induced LQT. More than 50 approved prescription drugs in various therapeutic classes are known to prolong the QT-interval, which in some patients leads to these life- threatening arrhythmias. Genaissance has a patent estate of more than 50 issued and pending patents in the United States and other countries relating to five cardiac ion channel genes associated with LQTS: KCNQ1, KCNH2 (HERG), SCN5A, KCNE1, KCNE2. Genaissance is currently marketing its proprietary FAMILION(TM) Test, a genetic test for cardiac channelopathies, including LQTS and Brugada Syndrome, to cardiologists and electrophysiologists, who commonly care for these patients. Genaissance also offers the FAMILION(TM) Test to pharmaceutical customers as a tool to understand the contribution of genetics to QT prolongation seen in clinical trial subjects.
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, the timing of its ability to enter into drug development collaborations with pharmaceutical companies, 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.
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