SALT LAKE CITY, March 17, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq: MYGN) today announced an expansion of the Company's collaboration with BioMarin Pharmaceutical Inc. Under the expanded collaboration, BioMarin will use Myriad's myChoice HRD™ companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib. Financial terms were not disclosed.
Talazoparib is an investigational poly-ADP ribose polymerase (PARP) inhibitor being developed by BioMarin. In the expanded relationship, the companies also will collaborate under FDA regulations and guidelines for the development and potential regulatory approval requirements for both talazoparib and myChoice HRD.
"Myriad is a pioneer in personalized medicine. Our companion diagnostics are providing clinicians with valuable biological data to accelerate and improve healthcare for their patients," said Mark Capone, president of Myriad Genetic Laboratories. "With cancer treatments, there is no one-size-fits-all approach for patients. We are excited to be working with BioMarin to help identify the patients who are most likely to benefit from talazoparib based on their own genetic makeup and biology."
The expansion adds to an ongoing collaboration that began in September 2013, when BioMarin began using Myriad's BRACAnalysis CDx companion diagnostic test in its pivotal Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of talazoparib for advanced or metastatic breast cancer patients carrying BRCA mutations.
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 is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions, and assess risk of disease progression and recurrence. Myriad is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. 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 Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. 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, to BioMarin using the Company's myChoice HRD™ companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib; the Company initiating the FDA premarket approval process for myChoice HRD as a companion diagnostic with talazoparib; the Company's work with BioMarin helping to identify the patients who are most likely to benefit from talazoparib based on their own genetic makeup and biology; and the Company's strategic directives under the caption "About Myriad Genetics." 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 or will not continue to increase at historical rates; risks related to our ability to transition from our existing to new testing services, including unexpected costs and delays; 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 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; 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; 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2014, 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.
