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Myriad Genetics Receives Second Insurance Reimbursement Decision for its BRACAnalysis® Diagnostic System in Japan

1107 Days ago

BRACAnalysis Is Now Indicated as a Companion Diagnostic for Lynparza® (olaparib) in Women with Ovarian Cancer

SALT LAKE CITY, June 19, 2019 (GLOBE NEWSWIRE) -- 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 System
BRACAnalysis 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 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, 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 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; 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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