Myriad and BioMarin Expand Collaboration to Evaluate myChoice HRD(TM) as a Companion Diagnostic for Talazoparib
March 17 2015 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced an expansion of
the Company's collaboration with BioMarin Pharmaceutical Inc. Under
the expanded collaboration, BioMarin will use Myriad's myChoice
HRD™ companion diagnostic test to prospectively identify patients
with metastatic breast, ovarian and potentially other tumor types
that may be sensitive to talazoparib. Financial terms were not
disclosed.
Talazoparib is an investigational poly-ADP ribose polymerase
(PARP) inhibitor being developed by BioMarin. In the expanded
relationship, the companies also will collaborate under FDA
regulations and guidelines for the development and potential
regulatory approval requirements for both talazoparib and myChoice
HRD.
"Myriad is a pioneer in personalized medicine. Our
companion diagnostics are providing clinicians with valuable
biological data to accelerate and improve healthcare for their
patients," said Mark Capone, president of Myriad Genetic
Laboratories. "With cancer treatments, there is no
one-size-fits-all approach for patients. We are excited to be
working with BioMarin to help identify the patients who are most
likely to benefit from talazoparib based on their own genetic
makeup and biology."
The expansion adds to an ongoing collaboration that began in
September 2013, when BioMarin began using Myriad's BRACAnalysis CDx
companion diagnostic test in its pivotal Phase 3 EMBRACA and Phase
2 ABRAZO clinical studies of talazoparib for advanced or metastatic
breast cancer patients carrying BRCA mutations.
About myChoice HRD™
Myriad's myChoice HRD is the first homologous recombination
deficiency test that can detect when a tumor has lost the ability
to repair double-stranded DNA breaks, resulting in increased
susceptibility to DNA-damaging drugs such as platinum drugs or PARP
inhibitors. High myChoice HRD scores reflective of DNA repair
deficiencies are prevalent in all breast cancer subtypes, ovarian
and most other major cancers. In previously published data,
Myriad showed that the myChoice HRD test predicted drug response to
platinum therapy in certain patients with triple-negative breast
and ovarian cancers. It is estimated that 1.8 million people
in the United States and Europe who are diagnosed with cancers
annually may be candidates for treatment with DNA-damaging
agents.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions, and
assess risk of disease progression and recurrence. Myriad is
focused on strategic initiatives to grow existing markets,
diversify through the introduction of new products, including
companion diagnostics, and expand internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung
Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks
or registered trademarks of Myriad Genetics, Inc. in the United
States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, to BioMarin using the Company's myChoice HRD™ companion
diagnostic test to prospectively identify patients with metastatic
breast, ovarian and potentially other tumor types that may be
sensitive to talazoparib; the Company initiating the FDA premarket
approval process for myChoice HRD as a companion diagnostic with
talazoparib; the Company's work with BioMarin helping to identify
the patients who are most likely to benefit from talazoparib based
on their own genetic makeup and biology; and the Company's
strategic directives under the caption "About Myriad Genetics."
These risks and uncertainties include, but are not limited to: the
risk that sales and profit margins of our molecular diagnostic
tests and pharmaceutical and clinical services may decline or will
not continue to increase at historical rates; risks related to our
ability to transition from our existing to new testing services,
including unexpected costs and delays; risks related to changes in
the governmental or private insurers' reimbursement levels for our
tests or our ability to obtain reimbursement for our new tests at
comparable levels to our existing tests; risks related to increased
competition and the development of new competing tests and
services; the risk that we may be unable to develop or achieve
commercial success for additional molecular diagnostic tests and
pharmaceutical and clinical services in a timely manner, or at all;
the risk that we may not successfully develop new markets for our
molecular diagnostic tests and pharmaceutical and clinical
services, including our ability to successfully generate revenue
outside the United States; the risk that licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical services and any future tests and services are terminated
or cannot be maintained on satisfactory terms; risks related to
delays or other problems with operating our laboratory testing
facilities; risks related to public concern over our genetic
testing in general or our tests in particular; risks related to
regulatory requirements or enforcement in the United States and
foreign countries and changes in the structure of the healthcare
system or healthcare payment systems; risks related to our ability
to obtain new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; the
risk that we or our licensors may be unable to protect or that
third parties will infringe the proprietary technologies underlying
our tests; the risk of patent-infringement claims or challenges to
the validity of our patents or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical services
and patents or enforcement in the United States and foreign
countries, such as the Supreme Court decision in the lawsuit
brought against us by the Association for Molecular Pathology et
al; risks of new, changing and competitive technologies and
regulations in the United States and internationally; and other
factors discussed under the heading "Risk Factors" contained in
Item 1A of our Annual Report on Form 10-K for the fiscal year ended
June 30, 2014, which has been filed with the Securities and
Exchange Commission, as well as 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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