Myriad Genetic Laboratories, Inc., a wholly-owned subsidiary of
Myriad Genetics, Inc. (NASDAQ:MYGN), announced today that the
Japanese Ministry of Health, Labour, and Welfare has granted
manufacturing and marketing approval for Myriad’s
BRACAnalysis
® Diagnostic System (hereinafter
referred to as “BRACAnalysis”) to be used as a companion diagnostic
with the PARP inhibitor, Lynparza. Lynparza is marketed by
AstraZeneca and Merck, known as MSD outside the United States and
Canada.
“Our long-standing collaboration with Myriad Genetics Inc. has
now delivered an innovative companion diagnostic to breast cancer
patients in Japan, demonstrating our shared ambition to target
precision medicines to the right patients across the globe,” said
Ruth March, Ph.D., senior vice president, Head of Precision
Medicine and Genomics, AstraZeneca.
AstraZeneca and Merck are seeking approval of Lynparza in Japan
for treating patients with BRCA-mutated metastatic breast cancer.
BRACAnalysis is the first and only diagnostic test for a PARP
inhibitor to receive regulatory approval in Japan. The test
is marketed in the United States as BRCAnalysis CDx®.
“Receiving regulatory approval in Japan is a major milestone for
the company and reflects the high quality standards inherent in all
of our laboratory tests,” said Gary A. King, executive vice
president of International Operations. “As the only approved
test in Japan, we will collaborate with our commercial partners to
ensure patients with metastatic breast cancer have broad access to
BRACAnalysis and Lynparza, once it is approved.”
Currently there are about 40,000 patients with metastatic
disease that would be eligible for BRACAnalysis testing in Japan,
with an estimated 15,000 new cases of HER2-negative breast cancer
diagnosed each year. Myriad will commercialize BRACAnalysis
in exclusive partnership with the SRL Inc., a subsidiary of Miraca
Group, and one of the largest laboratory service providers in
Japan.
“Breast cancer doctors in Japan can offer BRACAnalysis to their
patients with metastatic breast cancer to determine if the carry
germline BRCA1 or BRCA2 gene mutations,” said Johnathan Lancaster,
M.D., Ph.D., gynaecological oncologist and chief medical officer,
Myriad Genetics, Inc. “Importantly, patients who are found to
carry a BRCA mutation could soon be considered for treatment with
Lynparza.”
About the BRACAnalysis®
Diagnostic
SystemBRACAnalysis is a diagnostic system that classifies
a patient’s clinically significant variants (DNA sequence
variations) in the 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.
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 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 use of the BRACAnalysis Diagnostic
System as a companion diagnostic with AstraZeneca’s PARP inhibitor,
Lynparza; AstraZeneca’s seeking approval of Lynparza in Japan for
treating patients with germline BRCA-mutated HER2-negative
metastatic breast cancer; the Company’s collaboration with its
commercial partners to ensure patients with metastatic breast
cancer have broad access to the BRACAnalysis Diagnostic System and
Lynparza following approval; the number of patients with metastatic
disease that would be eligible for BRACAnalysis Diagnostic System
testing in Japan, and the estimate of the number of new cases of
HER2-negative metastatic breast cancer which are diagnosed each
year in Japan; the Company’s commercialization of the BRACAnalysis
Device System in partnership with the SRL Inc., a subsidiary of
Miraca Group; 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: |
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Ron
Rogers(801) 584-3065rrogers@myriad.com |
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Investor
Contact: |
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Scott
Gleason(801) 584-1143sgleason@myriad.com |
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