SALT LAKE CITY, Utah, May 30, 2014 - Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics, announced the presentation of new data at the American Society of Clinical Oncology (ASCO) meeting this week that supports the clinical efficacy of its BRACAnalysis CDx™ and HRD™ tests in predicting platinum based therapy response for breast cancer patients. Additionally, the company is providing an update on key commercial milestones that underscore its commitment to the field of companion diagnostics.
"Myriad is committed to advancing the science of companion diagnostics and is currently working with approximately 20 different pharmaceutical companies on companion diagnostic programs," said Mark Capone, president of Myriad Genetic Laboratories. "We believe the future of pharmaceuticals depends on providing therapeutics to patients that are tailored to their individual genetic makeup, and we are investing substantial resources to maintain our global leadership position in this field."
Data on BRACAnalysis CDx in Metastatic Breast Cancer Patients At this week's ASCO meeting, Myriad will present data supporting BRACAnalysis CDx's ability to predict platinum response in metastatic breast cancer patients. In a trial of 86 patients, the response rates to platinum based therapies (carboplatin and cisplatin) for patients with deleterious mutations detected by BRACAnalysis CDx (the Company's proprietary companion diagnostic test for deleterious mutations and large rearrangements in the BRCA1 and BRCA2 genes) was 54.5 percent compared to only 19.7 percent in the non-carrier group. These data underscore the ability of BRACAnalysis CDx to predict patient response to platinum based therapies in a patient population characterized by low overall response rates.
Myriad is making substantial progress toward the commercialization of BRACAnalysis CDx for PARP inhibitors and several of Myriad's commercial pharmaceutical partners have recently made major announcements on the advancement and expansion of their PARP inhibitor programs. Below is a table summarizing the announced, late-stage clinical trials by commercial partners in which Myriad is providing the companion diagnostic test in support of the drug.
|Company||Drug||Clinical Trial Phase/Indications||Timeline||Myriad Test|
|AstraZeneca||olaparib||Phase 3 - platinum sensitive relapsed ovarian cancer|
|Phase 3 - first line maintenance therapy for ovarian cancer|
|Phase 3 - metastatic breast cancer|
|Phase 3 - neoadjuvant breast cancer|
|Phase 3 - adjuvant breast cancer||Expect U.S. FDA and EMA approval for platinum sensitive ovarian cancer in CY15. Expect to file with the FDA for breast cancer in CY16.||BRACAnalysis CDx™|
|Biomarin||BMN-673||Phase 3 - metastatic breast cancer||NA||BRACAnalysis CDx™|
|AbbVie||veliparib||Phase 3 - neoadjuvant treatment of triple negative breast cancer||NA||BRACAnalysis CDx™|
|Tesaro||niraparib||Phase 3 - platinum sensitive ovarian cancer|
|Phase 3 - metastatic breast cancer||NA||BRACAnalysis CDx™|
"In the area of cancer, we are seeing significant progress by our pharmaceutical partners in the advancement of PARP inhibitors toward commercialization in a variety of cancer types and we are excited to be providing best-in-class diagnostics in support of these important therapeutics," said Capone. "Myriad is uniquely positioned as a global diagnostic company to provide these highly complex tests with the accuracy and turnaround times required to have a positive impact on patient care."
New Data on Myriad's Proprietary HRD Test Supports Planned Commercial Launch in FY15 Myriad also will present data looking at the ability of the Company's proprietary HRD tumor test in terms of its ability to predict response among triple negative breast cancer patients. The combination of Myriad's three HRD assays including Loss of Heterogyzosity (LOH), Telomere Allelic Imbalance (TAI), and Large-Scale State Transition (LST) were highly correlated with patient response rates. These data further highlight the likely utility of HRD as a more comprehensive companion diagnostic for DNA damaging agents.
In addition, Myriad announced a new 160 patient randomized study evaluating HRD as a biomarker for prediction of cisplatin and paclitaxel response in triple negative breast cancer patients at diagnosis. This is one of several ongoing clinical trials Myriad is conducting looking at the predictive power of HRD in guiding platinum based therapy. Myriad plans to present data later this year on HRD that will support an early access launch of the test in triple negative breast cancer patients in late fiscal year 2015.
"High HRD scores have been shown in early research to be highly correlated with response rates to DNA damaging agents such as platinum based therapies," said Jerry Lanchbury, chief scientific officer at Myriad Genetics. "We believe that, with further validation, the HRD test has the potential to become the gold standard diagnostic to identify patients who have lost DNA repair function and are most suitable for this class of therapeutics."
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 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: http://www.
Myriad, the Myriad logo, BRACAnalysis CDx, HRD, Prolaris, Myriad myPath, Myriad myPlan and Myriad myRisk 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, including statements relating to the clinical efficacy of the Company's HRD and BRACAnalysis CDx assays in predicting therapy response for cancer patients; the Company's commitment to advancing the science of companion diagnostics and work with multiple pharmaceutical companies on companion diagnostic programs; the Company's belief that the future of pharmaceuticals depends on providing therapeutics to patients that are tailored to their individual genetic makeup, and the Company's investment of substantial resources to maintain our global leadership position in this field; the significant clinical utility of the BRACAnalysis CDx test at predicting response rates to platinum based therapies; the ability of the HRD test to predict response among triple negative breast cancer patients and its utility as a more comprehensive companion diagnostic for DNA damaging agents; the Company's plan for an early access launch of the HRD test in triple negative breast cancer patients in late fiscal year 2015; the Company's belief that with further validation the HRD test has the potential to become the gold standard diagnostic to identify patients who have lost DNA repair function and are most suitable for this class of therapeutics; the statements and information under the caption "Progress With Commercial Partners on 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; risks related to increased competition and the development of new competing tests 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; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic 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 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.