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Press Release

Myriad Receives Pre-Market Approval for its BRACAnalysis® Diagnostic System in Japan


Posted on: 02 Apr 18

SALT LAKE CITY, April 02, 2018 (GLOBE NEWSWIRE) -- 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 System
BRACAnalysis 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 SLR
Since 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 Genetics
Myriad 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 Statement
This 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:     Ron Rogers
(801) 584-3065
rrogers@myriad.com
     Investor Contact:     Scott Gleason
(801) 584-1143
sgleason@myriad.com
       
GlobeNewswire
globenewswire.com

Last updated on: 02/04/2018

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