Myriad and AstraZeneca Expand Research Collaboration on Lynparza
SALT LAKE CITY, April 1, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the expansion of its companion diagnostic collaboration with AstraZeneca. Under the terms of the expanded agreement, Myriad's BRACAnalysis CDx test will be used to prospectively identify which patients with metastatic pancreatic cancer may respond to treatment with Lynparza™ (olaparib).1 Lynparza is a PARP (poly-ADP ribose polymerase) inhibitor being developed by AstraZeneca. More than 48,000 people are diagnosed with pancreatic cancer and more than 40,000 will die from the disease each year in the United States.2
"Pancreatic cancer is one of the few cancers for which survival has not improved substantially in the last 40 years, and the average life expectancy after diagnosis with metastatic disease is three to six months," said Mark Capone, president, Myriad Genetic Laboratories. "Our collaboration with AstraZeneca is a big step forward in the fight against pancreatic cancer and in ensuring that personalized medicine becomes reality. BRACAnalysis CDx has the potential to quickly and accurately identify those patients who may be candidates for treatment with Lynparza and hopefully to accelerate better health outcomes."
In December 2014, the U.S. Food and Drug Administration (FDA) approved BRACAnalysis CDx to identify ovarian cancer patients with germline mutations in BRCA1/2 who may be appropriate for treatment with Lynparza. The approval of BRACAnalysis CDx was the first time the FDA has approved a complex laboratory developed test (LDT) under the premarket approval application process and was the first-ever approval of an LDT companion diagnostic test.
1 A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy. (https://clinicaltrials.gov/ct2/show/NCT02184195?term=olaparib+pancreatic+cancer&rank=2)
2 American Cancer Society website. Data accessible online at: www.cancer.org/cancer/pancreaticcancer/detailedguide/pancreatic-cancer-key-statistics
About BRACAnalysis CDx™
BRACAnalysis CDx™ is an FDA-approved in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens.
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
Note to Editors:
Lynparza is a trademark of AstraZeneca.
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 BRACAnalysis CDx testing being used in clinical trials of patients with pancreatic cancer to prospectively identify which patients may respond to treatment with Lynparza; the BRACAnalysisCDx test improving patient care by identifying candidates for treatment with Lynparza; 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.
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