24.01.2008 13:00:00
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Clinical Data and Affymetrix Announce Marketing Agreement for New Drug Metabolism Service
Clinical Data Inc. (NASDAQ:CLDA) and Affymetrix Inc. (NASDAQ:AFFX) today
announced a marketing agreement for a new drug metabolism service using
the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) Early
Access solution. Cogenics and Epidauros Biotechnologie AG, both
subsidiaries of Clinical Data Inc., will offer the DMET services on a
global basis, with limited exclusivity in Europe. Affymetrix (DMET)
Early Access solution is currently the world’s
most comprehensive method for assaying the genetics of drug metabolism.
The service will enable pharmaceutical customers to generate
comprehensive genetic profiles of a patient’s
metabolic status to gain a better understanding of pharmacokinetic drug
response. In a separate release issued today, Affymetrix announced the
availability of its DMET Early Access Solution.
Affymetrix has been working closely with Cogenics to develop the DMET
technology, which directly assays 1,069 total biomarkers in 160
Absorption, Distribution, Metabolism and Excretion (ADME) genes. The kit
includes cytochrome p450 enzymes and drug transporters like MDR1,
genetic biomarkers with which Cogenics and Epidauros have extensive
working experience.
"The Affymetrix DMET Early Access solution is
the only product with comprehensive coverage of all ADME drug metabolism
biomarkers to date. As the first certified DMET commercial provider, we
have analyzed thousands of DMET samples over the last few years and we
are confident that our Early Access service offering will yield
valuable, high-quality data to our pharmaceutical partners on a global
basis,” said Michael Lutz, Global General
Manager of Cogenics and Chief Executive Officer of Epidauros.
"We believe that Cogenics’
and Epidauros’ expertise in genetic biomarker
discovery and history with ADME studies will greatly enhance the DMET
offering by making it more attractive, comprehensive and valuable to
pharmaceutical customers seeking to address drug metabolism issues that
arise in drug development,” said Pratima Rao,
Senior Director of Product Marketing at Affymetrix.
For more information on Cogenics’ and
Epidauros’ DMET solutions, please call
1-877-226-4364 (U.S.) or +49 8158 9985 0 (E.U.), or email sales@cogenics.com
or contact@epidauros.com. About Clinical Data Inc.
Clinical Data, Inc. is unlocking the potential of molecular discovery,
From Targeted Science to Better Healthcare™.
Its PGxHealth™ division focuses on
proprietary biomarker and pharmacogenetic test development as well as
targeted therapeutics to help predict drug safety and efficacy, thereby
reducing health care costs and improving clinical outcomes. Its Cogenics™
division provides a broad range of molecular and pharmacogenomics
services to pharmaceutical, biotechnology, and academic organizations in
both research and regulated environments. Through these divisions,
Clinical Data is leveraging advances in pharmacogenomics to provide
tangible benefits for patients, doctors, scientists and health plans
worldwide. Visit the company's website at www.clda.com
for more information.
About Cogenics and Epidauros
Cogenics, a subsidiary of Clinical Data, offers more than 18 years of
experience as a trusted provider of the broadest range of
pharmacogenomics and molecular biology services available globally.
Cogenics provides integrated services for nucleic acid extraction,
genotyping, sequencing, QPCR, and gene expression, as well as serving as
a biorepository, for both research and regulated environments: GLP, cGMP
and CLIA. Cogenics combines operations from the acquisitions of
Genaissance Pharmaceuticals, Lark Technologies (US & UK), Icoria, Genome
Express (France) and Epidauros (Germany). Its customers include some of
the world’s most respected pharmaceutical and
biotechnology companies, agencies of the US National Institutes of
Health, leading government and academic researchers in the international
life science community, and major agricultural companies and agencies.
For more information, please visit www.cogenics.com.
Epidauros was acquired by Clinical Data in 2007. Before the acquisition,
the company has established itself as a worldwide leading
Pharmacogenetic Research Organization (PRO) providing innovative,
integrated and value-added solutions to an international customer base
consisting of pharmaceutical companies, CROs and other companies acting
in the field of health care. Since its foundation in 1997, Epidauros has
brought together a network of competent partners to do
pharmacogenetic-related research and has established its own
intellectual property base in the field of drug transporters, e.g. MDR1
and cytochrome P450 enzymes. The company is located in Bernried near
Munich. For more information, please visit www.epidauros.com.
About Affymetrix
Affymetrix GeneChip®
microarray technology is the industry-standard tool for analyzing
complex genetic information. After inventing microarray technology in
the late 1980s, Affymetrix scientists have been dedicated to developing
innovative products that provide researchers with a more complete view
of the genome. These products continue to accelerate genetic research
and enable scientists to develop diagnostics and tailor treatments for
individual patients by identifying and measuring the genetic information
associated with complex diseases.
Today, Affymetrix technology is used by the world’s
top pharmaceutical, diagnostic and biotechnology companies, as well as
leading academic, government and not-for-profit research institutes.
More than 1,600 systems have been shipped around the world and more than
10,500 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has
manufacturing facilities in Sacramento, Calif., and Singapore. The
company has about 1,100 employees worldwide and maintains sales and
distribution operations across Europe and Asia. For more information
about Affymetrix, please visit: www.affymetrix.com.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995 Forward-looking Statements of Clinical Data, Inc. This press release contains certain forward-looking information about
Clinical Data that is intended to be covered by the safe harbor for "forward-looking
statements” provided by the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. Words such as "expect(s),” "feel(s),” "believe(s),” "will,” "may,” "anticipate(s)”
and similar expressions are intended to identify forward-looking
statements. These statements include, but are not limited to statements
regarding: our ability to successfully integrate the operations,
business, technology and intellectual property obtained in our
acquisitions; our ability to obtain regulatory approval for, and
successfully introduce our new products; our ability to expand our
long-term business opportunities; our ability to maintain normal terms
with our customers and partners; financial projections and estimates and
their underlying assumptions; and statements regarding future
performance. All of such statements are subject to certain risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of the Company, that could cause actual results to
differ materially from those expressed in, or implied or projected by,
the forward-looking information and statements. These risks and
uncertainties include, but are not limited to: whether and to what
extent the DMET offering will be accepted by the market; the extent to
which genetic markers (haplotypes) are predictive of clinical outcomes
and drug efficacy and safety; our ability to achieve the expected
synergies and operating efficiencies from all of our acquisitions; the
strength of our intellectual property rights; competition from
pharmaceutical, biotechnology and diagnostics companies; the development
of and our ability to take advantage of the market for pharmacogenetic
and biomarker products and services; general economic downturns; and
other risks contained in our various SEC reports and filings, including
but not limited to our Annual Report on Form 10-K for the fiscal year
ended March 31, 2007, our Quarterly Report on Form 10-Q for the fiscal
quarter ended September 30, 2007, and our Current Reports on Form 8-K
filed with the Securities and Exchange Commission. Readers are cautioned
not to place undue reliance on these forward-looking statements that
speak only as of the date hereof, and we do not undertake any obligation
to revise and disseminate forward-looking statements to reflect events
or circumstances after the date hereof, or to reflect the occurrence of
or non-occurrence of any events. Forward-looking Statements of Affymetrix, Inc. All statements in this press release that are not historical are "forward-looking
statements” within the meaning of Section 21E
of the Securities Exchange Act as amended, including statements
regarding Affymetrix’ "expectations,” "beliefs,” "hopes,” "intentions,” "strategies”
or the like. Such statements are subject to risks and uncertainties that
could cause actual results to differ materially for Affymetrix from
those projected, including, but not limited to: risks and uncertainties
relating to commercial success of the marketing agreement between
Affymetrix, Clinical Data, Cogenics and Epidauros Biotechnologie AG
discussed in this press release; risks of the company’s
ability to achieve and sustain higher levels of revenue, higher gross
margins and reduced operating expenses; uncertainties related to
technological approaches, manufacturing and product development;
personnel retention; uncertainties related to cost and pricing of
Affymetrix products; dependence on collaborative partners; uncertainties
related to sole-source suppliers; risks associated with acquisitions;
uncertainties relating to FDA and other regulatory approvals;
competition; risks relating to intellectual property of others and the
uncertainties of patent protection and litigation. These and other risk
factors are discussed in Affymetrix’ Form
10-K for the year ended December 31, 2006, and other SEC reports,
including its Quarterly Reports on Form 10-Q for subsequent quarterly
periods. Affymetrix expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Affymetrix’
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
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