AstraZeneca Advances PARP Inhibitor Into Phase 3 Trial With BRACAnalysis(R)
Myriad to Seek FDA Approval for BRACAnalysis as Companion Diagnostic
SALT LAKE CITY, June 1, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that AstraZeneca will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States.
"We are pioneers in personalized medicine and believe the future of drug development is using companion diagnostics to identify responders and non-responders to therapy," said Peter D. Meldrum, president and CEO of Myriad. "BRACAnalysis testing has shown significant potential as a companion diagnostic to select which patients will respond to PARP inhibitors, and we look forward to collaborating with AstraZeneca on the clinical program for olaparib."
While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer™ for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic -- following review by FDA -- to help select patients who are likely to respond to poly ADP ribose polymerase (PARP) inhibitors, a novel, targeted class of promising cancer therapeutics.
Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
"Myriad has a proven track record with high-quality BRAC mutation testing for hereditary breast and ovarian cancer, and we are excited by the potential for BRACAnalysis to be useful as a companion diagnostic that will help clinicians to select cancer patients who are appropriate candidates for receiving olaparib," said Ruth March, vice president and head of Personalised Healthcare and Biomarkers at AstraZeneca.
BRACAnalysis is a genetic test that confirms the presence of a BRCA1 or BRCA2 gene mutation. BRCA mutations are responsible for the majority of hereditary breast and ovarian cancers. People with a mutation in either the BRCA1 or BRCA2 gene have risks of up to 87% for developing breast cancer and up to 44% for developing ovarian cancer by age 70. Mutation carriers previously diagnosed with cancer also have a significantly increased risk of developing a second primary cancer. Genetic testing, specifically the BRACAnalysis test, identifies patients who have these mutations.
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's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding 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, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. 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 Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib; the submission and approval of BRACAnalysis testing for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for BRACAnalysis testing to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States; the replacement of BRACAnalysis testing with myRisk Hereditary Cancer™ for hereditary cancer testing, and the offering of BRACAnalysis testing as a companion diagnostic -- following review by FDA -- to help select
patients who are likely to respond to poly ADP ribose polymerase (PARP) inhibitors; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present 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 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 companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic
services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; 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 in our most recent Annual Report on Form 10-K 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.
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Source: Myriad Genetics, Inc.
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