deCODE genetics (NASDAQ:DCGN) and Celera Corporation
(NASDAQ:CRA) today announced the signing of agreements under which
deCODE has granted Celera non-exclusive worldwide licenses to
deCODE�s genetic markers for increased risk of major cardiovascular
and metabolic diseases, including heart attack, stroke, atrial
fibrillation (AF) and type 2 diabetes (T2D). These markers can be
incorporated into laboratory tests for assessing and managing
individual risk of these diseases.
The deCODE markers include single letter variations in the human
genome (SNPs) on chromosome 9p21 linked to increased risk of heart
attack and aortic aneurysm, SNPs on chromosome 4q25 conferring risk
of AF and stroke, and SNPs in the TCF7L2 gene linked to increased
risk of T2D. Studies by deCODE and independent academic groups have
demonstrated the utility of testing for these markers to better
understand individual risk and to inform more effective and
personalized prevention and therapy.
Individuals who carry two copies of the at-risk SNPs on
chromosome 9p21 are at an approximately 60% greater than average
risk of early-onset heart attack1, and physicians could use this
information and expert opinion to optimize the appropriate
lifestyle, dietary and drug treatments for their patients2.
Carrying two copies of the SNPs on 4q25 correlates to both an
increased risk of stroke and up to twice the average risk of AF3, a
common cardiac arrhythmia and a major cause of cardiogenic stroke.
Testing for this risk factor provides a new means of identifying
stroke patients who could most benefit from outpatient cardiac
monitoring. The SNPs in TCF7L2 are the most important genetic risk
factor yet found for type 2 diabetes4. Testing individuals with
borderline elevated glucose (prediabetes) can identify those who
are most likely to progress rapidly to full-blown T2D, and testing
can also help to predict therapeutic response to sulfonylureas.
Under the terms of the agreements, deCODE will receive an
upfront payment and royalties on sales of testing products
incorporating its markers. Additional financial details were not
disclosed.
�This is an excellent opportunity to broaden the clinical
application and commercialization of our discoveries of high-impact
genetic risk factors for major diseases. The markers included in
these agreements are among the most widely replicated genetic risk
factors for cardiovascular and metabolic disease, and they provide
a natural complement to the biomarker services already offered by
Berkeley HeartLab, Celera�s subsidiary. In Celera we have a partner
with a global reputation in human genetics and a large and
effective outreach and sales force. We are pleased to have the
chance to work with them to build upon our discovery and testing
platforms and to accelerate the adoption of personalized medicine,�
said Kari Stefansson CEO of deCODE.
�We believe access to these highly replicated markers, which
complement our internal proprietary genetic discoveries in
cardiovascular disease such as KIF6 and LPA, furthers Celera�s
commitment to be a leading provider of genetic tests used routinely
in personalizing disease management,� said Kathy Ordo�ez, CEO of
Celera. �We expect Berkeley HeartLab to incorporate these markers
into future laboratory service offerings, and Celera plans to
ultimately commercialize them globally as new molecular diagnostic
tests through our Products business. We believe these markers that
predict risk of coronary heart disease and drug response could
produce highly differentiated, proprietary, and compelling tests
that personalize cardiovascular disease management.�
About deCODE
deCODE is a biopharmaceutical company developing drugs and
DNA-based tests to improve the treatment, diagnosis and prevention
of common diseases. Its lead therapeutic programs, which leverage
the company�s expertise in chemistry and structural biology,
include DG041, an antiplatelet compound being developed for the
prevention of arterial thrombosis; DG051 and DG031, compounds
targeting the leukotriene pathway for the prevention of heart
attack; and DG071 and a platform for other PDE4 modulators with
therapeutic applications in Alzheimer�s disease and other
conditions. deCODE is a global leader in human genetics, and has
identified key variations in the genome (SNPs) conferring increased
risk of major public health challenges from cardiovascular disease
to cancer. Based upon these discoveries deCODE has brought to
market a growing range of DNA-based tests for gauging risk and
empowering prevention of common diseases. Through its
CLIA-registered laboratory, deCODE is offers deCODE T2� for type 2
diabetes; deCODE AF� for atrial fibrillation and stroke; deCODE MI�
for heart attack; deCODE ProstateCancer� for prostate cancer;
deCODE Glaucoma� for a major type of glaucoma; and deCODE
BreastCancer, for the common forms of breast cancer. deCODE is
delivering on the promise of the new genetics.SM Visit us on the
web at www.decode.com; on our diagnostics site at
www.decodediagnostics.com; for our pioneering personal genome
analysis service and new focused disease scans, integrating the
genetic variants included in these tests and those linked to
another twenty common diseases, as well as for our new deCODEme
Cardio� and deCODEme Cancer�, at www.decodeme.com; and on our blog
at www.decodeyou.com.
Forward Looking Statements - deCODE
Any statements contained in this presentation that relate to
future plans, events or performance are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are subject to a number
of risks and uncertainties that could cause actual results, and the
timing of events, to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
among others, those relating to our ability to obtain sufficient
financing to continue as a going concern,, the effect of a
potential delisting of our common stock from The Nasdaq Capital
Market, our ability to develop and market diagnostic products, the
level of third party reimbursement for our products, risks related
to preclinical and clinical development of pharmaceutical products,
including the identification of compounds and the completion of
clinical trials, our ability to form collaborative relationships,
the effect of government regulation and the regulatory approval
processes, market acceptance, our ability to obtain and protect
intellectual property rights for our products, dependence on
collaborative relationships, the effect of competitive products,
industry trends and other risks identified in deCODE�s filings with
the Securities and Exchange Commission, including, without
limitation, the risk factors identified in our most recent Annual
Report on Form 10-K and any updates to those risk factors filed
from time to time in our Quarterly Reports on Form 10-Q or Current
Reports on Form 8-K. deCODE undertakes no obligation to update or
alter these forward-looking statements as a result of new
information, future events or otherwise.
About Celera
Celera is a healthcare business delivering personalized disease
management through a combination of products and services
incorporating proprietary discoveries. Berkeley HeartLab, a
subsidiary of Celera, offers services to predict cardiovascular
disease risk and improve patient management. Celera also
commercializes a wide range of molecular diagnostic products
through Abbott and has licensed other relevant diagnostic
technologies developed to provide personalized disease management
in cancer and liver diseases. Information about Celera Corporation,
including reports and other information filed by the company with
the Securities and Exchange Commission, is available at
http://www.celera.com.
Forward-Looking Statements - Celera
Certain statements in this press release are forward-looking.
These may be identified by the use of forward-looking words or
phrases such as �believe,� �expect,� �will,� �could,� �anticipate,�
�plan,� and �intend,� among others. These forward-looking
statements are based on Celera�s current expectations. The Private
Securities Litigation Reform Act of 1995 provides a "safe harbor"
for such forward-looking statements. In order to comply with the
terms of the safe harbor, Celera notes that a variety of factors
could cause actual results and experience to differ materially from
the anticipated results or other expectations expressed in such
forward-looking statements. The risks and uncertainties that may
affect the operations, performance, development, and results of our
business include, but are not limited to, the risks and
uncertainties that: (1) Celera is using novel and unproven methods
to discover markers for the development of new diagnostic products,
which may not be successful; (2) the diagnostic industry is very
competitive, and new diagnostic products may not be accepted and
adopted by the market; (3) demand for diagnostic products may be
adversely affected if users of these products cannot receive
adequate reimbursement for these products from third party payors
such as private insurance companies and government insurance plans;
(4) potential product liability or other claims against Celera as a
result of the testing or use of its products; and (5) uncertainty
of the availability to Celera of intellectual property protection,
limitations on its ability to protect trade secrets, the risk to it
of infringement claims, and the possibility that it may need to
license intellectual property from third parties to avoid or settle
such claims. The foregoing list sets forth some, but not all, of
the factors that could affect Celera's ability to achieve results
described in any forward-looking statements. For additional
information about the risks and uncertainties that Celera faces and
a discussion of its financial statements and footnotes, see
documents filed by Celera with the SEC, including its transition
report on Form 10-KT and all subsequent periodic reports. All
information in this press release is as of the date of the release,
and Celera does not undertake any duty to update this information,
including any forward-looking statements, unless required by
law.
Selected references
1. Helgadottir, A., et al., �A common variant on chromosome 9p21
affects the risk of myocardial infarction,� Science (2007) 8;316
(5830):1491-3.
2. Brautbar, A, et al., �Impact of adding a single allele in the
9p21 locus to traditional risk factors on reclassification of
coronary heart disease risk and implications for lipid-modifying
therapy in the Atherosclerosis Risk in Communities (ARIC) study.
Circulation: Cardiovascular Genetics (2009). Published online ahead
of print, April 21, 2009.
3. Gudbjartsson, D.F., et al., �Variants conferring risk of
atrial fibrillation on chromosome 4q25,� Nature (2007) 448:353-57;
Gulcher J, Gretarsdottir S, Thorleifsson G, et al., Abstract 1171:
�Risk variants for atrial fibrillation on chromosome 4q25 associate
with non-cardiogenic stroke suggesting that AF is a much greater
cause of stroke than previously recognized,� Circulation
(2008);118:S_652.
4. Grant, et. al., "Variant of transcription factor 7-like 2
(TCF7L2) gene confers risk of type 2 diabetes," Nature Genetics
(2006) 38, 320 - 323; Florez, et. al., "TCF7L2 Polymorphisms and
Progression to Diabetes in the Diabetes Prevention Program," N Engl
J Med (2006); 355:241-250.
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