Myriad Genetics Announces Expanded Research Collaboration with AstraZeneca
January 03 2018 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that
AstraZeneca will use the Company’s myChoice® HRD Plus in an
exploratory analysis to identify women with advanced ovarian cancer
who may benefit from maintenance treatment with Lynparza (olaparib)
and Avastin (bevacizumab). Financial terms were not
disclosed.
Under the agreement, Myriad will use its myChoice HRD Plus test
to evaluate patients enrolled in an ongoing Phase III trial.
In this collaboration, the companies will use the myChoice HRD Plus
test to identify cases with homologous recombination deficiencies
(HRD).
“As the pioneer in companion diagnostics for PARP inhibitors, we
are excited to continue our collaboration with AstraZeneca and to
apply innovative new technologies like myChoice HRD Plus to
increase the number of patients who may benefit from Lynparza,”
said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad
Genetics. “myChoice HRD Plus is the most comprehensive test
for identifying defects in DNA repair pathways. We are
optimistic that myChoice HRD Plus will identify more women with
ovarian cancer who could benefit from therapy with Lynparza than
previous tests that only identify germline BRCA1/2
mutations.”
The ongoing collaboration with AstraZeneca to develop a novel
companion diagnostic test to identify candidates for treatment with
olaparib began in 2007. In Dec. 2014, Myriad received FDA
approval for BRACAnalysis CDx to help identify patients with
advanced ovarian cancer who are eligible for fourth-line treatment
with olaparib. BRACAnalysis CDx is Myriad’s first
FDA-approved companion diagnostic and was the first-ever laboratory
developed test approved by the FDA.
About Ovarian CancerOvarian cancer has the
lowest survival rate of all female cancers. Ovarian cancer is
diagnosed annually in nearly a quarter of a million women globally,
and is responsible for 140,000 deaths each year. Statistics show
that just 45 percent of women with ovarian cancer are likely to
survive for five years. The majority of patients are only
identified in the advanced stages when the disease becomes more
difficult to treat.
About myChoice® HRD
PlusMyriad's myChoice HRD Plus is the most comprehensive
homologous recombination deficiency test to 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. The myChoice HRD Plus test is a
composite of three proprietary technologies (loss of
heterozygosity, telomeric allelic imbalance and large-scale state
transitions) and up to 90 other genes and molecular markers
including microsatellite instability associated with DNA repair
pathways.
Positive myChoice HRD Plus scores, reflective of DNA repair
deficiencies, are prevalent in all breast cancer subtypes, ovarian
cancer and most other major cancers. It is estimated that 1.4
million people in the United States and Europe who are diagnosed
with cancers annually may be candidates for treatment with
DNA-damaging agents. Learn more:
http://myriadmychoice.com/
About Lynparza Lynparza (olaparib) is an
innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that exploits tumor DNA damage response (DDR) pathway
deficiencies to preferentially kill cancer cells. Lynparza is
the foundation of AstraZeneca’s industry-leading portfolio of
compounds targeting DNA damage response (DDR) mechanisms in cancer
cells. Lynparza is currently approved in the United States for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube or primary peritoneal cancer, who are in a
complete or partial response to platinum-based chemotherapy and for
the treatment of adult patients with deleterious or suspected
deleterious germline BRCA-mutated advanced ovarian cancer who have
been treated with three or more prior lines of chemotherapy.
Patients are selected for therapy based on Myriad’s FDA-approved
companion diagnostic. It is also approved by regulatory health
authorities in the EU for use as monotherapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed
BRCA-mutated (germline and/or somatic) high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
response (complete or partial) to platinum-based
chemotherapy.
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth,
NJ USA announced a global strategic oncology collaboration to
jointly co-develop and co-commercialize Lynparza.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
five strategic imperatives: Stabilizing hereditary cancer
revenue, growing new product volume, expanding reimbursement
coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. 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, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and
Prolaris are trademarks or registered trademarks of Myriad
Genetics, Inc. or its wholly owned subsidiaries in the United
States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to the Company’s expanded research
collaboration with AstraZeneca for the first phase III parp
inhibitor clinical trial to use myChoice HRD Plus as a potential
companion diagnostic in an exploratory analysis to identify women
with advanced ovarian cancer who may benefit from maintenance
treatment with Lynparza (olaparib) and Avastin (bevacizumab); the
use of the myChoice HRD Plus test to evaluate patients enrolled in
an ongoing Phase III trial to identify cases with homologous
recombination repair (HRR) deficiencies; myChoice HRD Plus being
able to identify more women with ovarian cancer who could benefit
from therapy with Lynparza than previous tests that only identify
germline BRCA1/2 mutations; and the Company’s strategic
directives under the caption “About Myriad Genetics.” These
“forward-looking statements” are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those described or implied in the
forward-looking statements. These risks include, but are not
limited to: the risk that sales and profit margins of our existing
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
product portfolio to our new tests; 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 tests and any future tests 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, including but not limited to our acquisition of Assurex,
Sividon and the Clinic; risks related to our projections about the
potential market opportunity for our products; 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; 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; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; 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, 2017, 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.
Media Contact:
Ron Rogers (801) 584-3065rrogers@myriad.com
Investor Contact:
Scott Gleason(801) 584-1143sgleason@myriad.com
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