Myriad Genetic Laboratories, Inc., a wholly-owned subsidiary of
Myriad Genetics, Inc. (NASDAQ: MYGN), today announced the Japanese
Ministry of Health, Labour, and Welfare has granted a second
manufacturing and marketing approval for Myriad’s
BRACAnalysis
® Diagnostic System (i.e.,
“BRACAnalysis”) as a companion diagnostic with the PARP inhibitor,
Lynparza® (olaparib). Lynparza is marketed by AstraZeneca
(LSE/STO/NYSE: AZN) and MSD (known as Merck & Co., Inc. in the
United States and Canada).
The decision allows physicians to use BRACAnalysis to identify
women with ovarian cancer who have a germline BRCA mutation and are
eligible for first-line maintenance therapy with Lynparza.
BRACAnalysis previously was approved in Japan for use in patients
with unresectable or recurrent breast cancer and is the only
companion diagnostic test for a PARP inhibitor to receive
regulatory approval in Japan.
“The approval of BRACAnalysis for women with ovarian cancer is a
major milestone for precision oncology in Japan,” said Gary A.
King, executive vice president of International Operations, Myriad
Genetics. “We will work with our commercial partners in Japan
to expand access to BRACAnalysis and Lynparza.”
Myriad will continue to commercialize BRACAnalysis in exclusive
partnership with SRL Inc., a subsidiary of Miraca Group, and one of
the largest laboratory service providers in Japan. According to
Japan’s National Cancer Center, there are approximately 10,000
patients diagnosed with ovarian cancer each year.
“The new approval shows the need for women with ovarian cancer
to receive a BRACAnalysis test at the time of diagnosis so they can
know their treatment options,” said Professor Daisuke Aoki, M.D.,
Ph.D., Department of Obstetrics and Gynecology, Keio University
School of Medicine and Chairperson of the Japan Society of
Gynecologic Oncology. “Women who are found to carry a
germline BRCA mutation are candidates for treatment with
Lynparza.”
“The approval of BRACAnalysis as a companion diagnostic for
Lynparza in women with ovarian cancer represents significant
progress in delivering precision medicine to Japanese patients via
our long-standing collaboration with Myriad Genetics Inc.,” said
Ruth March, Ph.D., senior vice president and head of Precision
Medicine, Oncology R&D, AstraZeneca.
About the BRACAnalysis®
Diagnostic
SystemBRACAnalysis is a diagnostic system that classifies
a patient’s clinically significant variants (DNA sequence
variations) in the germline BRCA1 and BRCA2 genes. Variants
are classified into one of the five categories; “Deleterious,”
“Suspected Deleterious,” “Variant of Uncertain Significance,”
“Favor Polymorphism,” or “Polymorphism.” Once the classification is
completed, the results are sent to medical personnel in Japan for
determining the eligibility of patients for treatment with
Lynparza.
Myriad has been collaborating with AstraZeneca since 2007 on the
development of companion diagnostics for Lynparza.
BRACAnalysis CDx® was approved by the United States Food and Drug
Administration (FDA) in December 2014 for patients with advanced
ovarian cancer and again in January 2018 for patients with
HER2-negative metastatic breast cancer. The test is marketed in the
United States as BRACAnalysis CDx®.
About Lynparza (olaparib)Lynparza is the first
approved oral poly ADP-ribose polymerase (PARP) inhibitor and the
first targeted treatment to potentially exploit DNA damage response
(DDR) pathway deficiencies, such as BRCA mutations, to
preferentially kill cancer cells. Specifically, in vitro
studies have shown that Lynparza-induced cytotoxicity may involve
inhibition of PARP enzymatic activity and increased formation of
PARP-DNA complexes, resulting in DNA damage and cancer cell
death. Lynparza is being investigated in a range of
DDR-deficient tumour types and is the foundation of AstraZeneca’s
industry-leading portfolio of compounds targeting DDR mechanisms in
cancer cells. Lynparza® is a registered trademark of
AstraZeneca. In July 2017, AstraZeneca and Merck announced a
global strategic oncology collaboration to jointly co-develop and
co-commercialize Lynparza.
About SLRSince the establishment in 1970, SRL,
Inc., a member of the Miraca Group, Japan-based leading healthcare
group, has been providing comprehensive testing services as the
largest commercial clinical laboratory in Japan. SRL carries
out nearly 400,000,000 tests per year, covering a wide range of
testing services including general/emergency testing,
esoteric/research testing, companion diagnostics tests, genomic
analysis, and etc. For more information, please visit
http://www.srl-group.co.jp/
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: build upon a solid hereditary
cancer foundation, 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, Prolaris,
Foresight and Prequel 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 use of the BRACAnalysis Diagnostic
System as a companion diagnostic with AstraZeneca’s PARP inhibitor;
the Company’s collaboration with its commercial partners to ensure
patients with ovarian cancer have broad access to the BRACAnalysis
Diagnostic System and Lynparza following approval; the number of
patients with ovarian cancer that would be eligible for
BRACAnalysis Diagnostic System testing in Japan, and the estimate
of the number of new cases of ovarian cancer which are diagnosed
each year in Japan; the Company’s continued commercialization of
the BRACAnalysis Device System in partnership with the SRL Inc.;
the approval of BRACAnalysis as a companion diagnostic for Lynparza
in women with ovarian cancer representing significant progress in
delivering precision medicine to Japanese patients; AstraZeneca’s
long-standing collaboration with the Company; 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 set forth in
or implied by forward-looking statements. 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; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in 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 and
our healthcare clinic; risks related to public concern over 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; 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 most recent Annual Report on
Form 10-K for the fiscal year ended June 30, 2018, 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. All information in this press release is as of the date
of the release, and Myriad undertakes no duty to update this
information unless required by law.
Media Contact:
Ron
Rogers
Investor Contact: Scott Gleason
(801) 584-3065
(801)
584-1143
rrogers@myriad.com
sgleason@myriad.com
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