Genaissance (NASDAQ:GNSC)
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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/