deCODE and Celera Partner to Expand use of deCODE Risk Markers for Heart Attack, Stroke and Diabetes
/PRNewswire-FirstCall/ — 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
attack(1), and physicians could use this information and expert opinion to
optimize the appropriate lifestyle, dietary and drug treatments for their
patients(2). Carrying two copies of the SNPs on 4q25 correlates to both an
increased risk of stroke and up to twice the average risk of AF(3), 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 diabetes(4). 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
Ordoñez, 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(TM) for type 2 diabetes; deCODE AF(TM)
for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE
ProstateCancer(TM) for prostate cancer; deCODE Glaucoma(TM) 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 http://www.decode.com; on our diagnostics site at
http://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(TM) and deCODEme Cancer(TM), at
http://www.decodeme.com; and on our blog at http://www.decodeyou.com.
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
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,” “should,” “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,
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.
Contacts:
deCODE genetics
Edward Farmer
+44(0)7796-010107
edward.farmer@decode.is
Joy Bessenger
+1-212-481-3891
ir@decode.is
Celera
David Speechly, Ph.D.
+1-510-749-1853
David.Speechly@celera.com
SOURCE deCODE genetics Inc