Myriad Genetics Announces Expanded Research Collaboration with AstraZeneca
SALT LAKE CITY, Jan. 03, 2018 (GLOBE NEWSWIRE) -- 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 Cancer
Ovarian 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 Plus
Myriad'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/
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 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: 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 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 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.