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Myriad Genetics, Inc. (MYGN) Announces Diabetes Collaboration With Sanofi (France) (SAN.PA)



12/11/2012 7:08:17 AM

SALT LAKE CITY, Dec. 10, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics (MYGN) announced today that Myriad RBM, a wholly owned subsidiary of Myriad Genetics, has entered into a research collaboration with Sanofi, a global and diversified healthcare leader, and Population Health Research Institute (PHRI) at Hamilton Health Sciences and McMaster University. Through this collaboration, Myriad RBM will perform protein biomarker research for the Outcome Reduction with Initial Glargine Intervention (ORIGIN) study, the world's longest and largest randomized clinical trial in pre- and early diabetes. The relationship between the biomarker results and clinical outcomes will be analyzed by investigators at PHRI.

As part of the agreement, Myriad RBM will analyze over 8,000 serum samples collected in the ORIGIN study using its DiscoveryMAP(R) 250+ quantitative immunoassay panel. Sanofi conceived of the application of Myriad RBM's technology to ORIGIN with a goal of identifying biomarker profiles that may optimize treatment and improve patient care.

"We are pleased to be partnering with Sanofi and PHRI, world leaders in diabetes research, on this critical study," said Craig Benson, President of Myriad RBM. "We believe this collaboration will result in better care for millions of patients with diabetes; a global epidemic that remains a critical unmet medical need."

Funded by Sanofi and directed and managed by PHRI, ORIGIN is a unique, six-year landmark cardiovascular (CV) outcomes trial, that evaluated Lantus(R) (insulin glargine) versus standard care in over 12,500 individuals at high CV risk with pre-diabetes or early type 2 diabetes mellitus. Spanning 40 countries worldwide, it was the world's longest and largest randomized clinical trial of its type in this population.

"This biomarker project using DiscoveryMAP is a logical extension of the landmark ORIGIN study," said Dr. Matt McQueen, Research Laboratory Director, PHRI. "The measurement of hundreds of relevant proteins in metabolic, inflammatory and other important pathways has the potential to improve treatment protocols for diabetes."

This collaboration could represent up to $10 million in companion diagnostic service revenue for Myriad over the next two fiscal years. Additionally, this agreement was contemplated in the Company's Companion Diagnostic Service revenue revised guidance for fiscal 2013 which was previously communicated on November 5, 2012.

About Myriad RBM

Myriad RBM's biomarker discovery platform provides clinical researchers, physicians and healthcare providers with reproducible, quantitative, multiplexed data for hundreds of proteins to advance drug development and patient care. The company's proprietary Multi Analyte Profiling (MAP) technology offers pre-clinical and clinical researchers broad, cost-effective analyses of multiple proteins from a single, small sample volume. MAP technology also supports Myriad RBM's drive to develop companion diagnostics in areas of unmet medical need such as neuropsychiatry, nephrology, and immunology. Myriad RBM is a wholly owned subsidiary of Myriad Genetics. More information about Myriad RBM is located at www.myriadrbm.com.

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, Myriad RBM, DiscoveryMAP 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 timing, scope, goals, completion, and anticipated outcomes of the collaboration and study to perform protein biomarker discovery on over 8,000 serum samples from patients with pre-diabetes or type 2 diabetes; the Company's belief that this collaboration will result in better care for millions of patients with diabetes; the expectation of this collaboration representing, and the Company realizing, over $10 million in companion diagnostic service revenue for the Company over the next two fiscal years; the inclusion of this agreement in the Company's Companion Diagnostic Service revenue revised guidance for fiscal 2013; and the Company's strategic directives under the captions "About Myriad RBM" and "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 existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; the risk that we may be unable to expand into new markets outside of the United States; 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 and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 healthcare payment systems; risks related to our ability to obtain new corporate collaborations 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 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 and invalidity claims or challenges 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.

Contact:

Myriad Contacts:

Investor Relations

Jim Evans, Chief Financial Officer

(801) 584-1143

investors@myriad.com

Myriad RBM

Chris Martin, Director of Communications

(212) 275-2623

chris.martin@myriadrbm.com

Media Relations

Stephanie Ashe

Continuum Health Communications

sashe@continuumhealthcom.com


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