Genaissance Obtains License to Vanderbilt Patent Linking Genetics to Key Drug Safety Issue
January 26 2005 - 7:30AM
PR Newswire (US)
Genaissance Obtains License to Vanderbilt Patent Linking Genetics
to Key Drug Safety Issue - Method helps identify experimental drugs
that may induce life threatening cardiac arrhythmias before they
are brought to market - NEW HAVEN, Conn., Jan. 26
/PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc.
(NASDAQ:GNSC), 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. 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, 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.
DATASOURCE: Genaissance Pharmaceuticals, Inc. CONTACT: Kevin Rakin,
President and Chief Executive Officer, +1-203-786-3404, , 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) of
Redington, Inc., +1-203-222-7399, Web site:
http://www.genaissance.com/
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