Myriad Expands Diagnostic Research Collaboration with TESARO and Merck
Myriad Expands Diagnostic Research Collaboration with TESARO and Merck
Companion Diagnostic Portfolio to Evaluate Treatment Response in Patients with Triple Negative Breast Cancer or Ovarian Cancer
SALT LAKE CITY, UTAH, Feb. 22, 2016 – Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced a strategic research collaboration with TESARO and Merck, known as MSD outside the U.S. and Canada, to help identify potential responders to an investigational combination drug therapy using TESARO's PARP inhibitor (niraparib) plus KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.
Under the terms of the agreement, the companies will use Myriad's myChoice HRD™ test and new tumor tests to evaluate treatment response in a clinical trial evaluating the combination of niraparib plus pembrolizumab in patients with triple negative breast cancer (TNBC) or ovarian cancer. Other terms of the deal were not disclosed.
"The combination of a PARP inhibitor and anti-PD-1 antibody may offer a novel way to treat women with triple negative breast cancer or ovarian cancer," said Mary Lynne Hedley, Ph.D., president and COO of TESARO. "Our goal is to use Myriad's assays to help enrich for those patients who will respond to the treatment and have the best chance for success."
"Treatment options for patients with triple negative breast cancer are extremely limited," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics, Inc. "We are very excited to expand our collaboration with TESARO and Merck to determine if our novel companion diagnostic assays can optimize the potential for this experimental combination therapy."
The new agreement builds upon a collaboration with TESARO that began in March 2014. Since then, Myriad has been working with TESARO to use the myChoice HRD test to identify ovarian cancer patients who may respond to niraparib, which is in Phase 3 clinical development.
About myChoice HRD™
Myriad's myChoice HRD is the first homologous recombination deficiency test that can 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. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.
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 three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. 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, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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 related to the Company's proprietary companion diagnostic tests; the use of the Company's companion diagnostic tests to identify responders to an investigational combination drug therapy using niraparib plus pembrolizumab; the Company's support of, and successful outcome of, a clinical trial evaluating the combination therapy in patients with triple negative breast cancer (TNBC) or ovarian cancer; 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; 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, 2015, 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.