Clinical Data and Affymetrix Announce Marketing Agreement for New Drug Metabolism Service
25 January 2008 - 12:00AM
Business Wire
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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