Theradiag Announces Strategic Agreement with Miraca Life Sciences in the USA

Regulatory News:

Theradiag (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER) announced today a strategic licensing agreement with Miraca Life Sciences ("MLS”) to offer in the United States Theradiag’s flagship therapeutic drug monitoring assays, which are marketed in Europe and outside the United States under the LISA TRACKER® brand name.

"Entering the U.S. market is central to Theradiag’s strategy to advance its therapeutic drug monitoring assay globally and could be a game changer for the company,” commented Michel Finance, CEO of Theradiag. "This deal will help to continue our strong growth and market penetration. As a leading specialty pathology laboratory, MLS is the best suited partner for Theradiag in the U.S. We have the utmost confidence that this agreement will increase Theradiag’s overall revenue.”

Under the collaboration, Theradiag will grant MLS an exclusive know-how license for the validation, commercialization and promotion in the U.S. of therapeutic drug monitoring assays.

"This licensing agreement with Theradiag enables MLS to offer testing in the United States that will benefit our clients and their patients. We hope to significantly increase the utilization of biologic drug monitoring across the U.S.,” commented Dr. Frank Basile, CEO of Miraca Life Sciences.

It is estimated more than 330,000 IBD patients in the United States are treated with biologics¹, two times more than in Europe. Theradiag estimates that the U.S. market could represent a major part of the future revenue of its Theranostic business unit.

Under the agreement, MLS will conduct validation studies and market therapeutic drug monitoring tests throughout the U.S. via its specialized sales force. MLS also will promote therapeutic drug monitoring testing with key opinion leaders, laboratories and other advocates in the U.S. healthcare field.

"The interest shown in our assays by MLS, a leading specialty pathology laboratory, brings another strong validation to our theranostic approach. It also speaks to the interest of the corporate healthcare sector and medical community in biotherapy monitoring,” concluded Gérard Tobelem, Chairman of the Board of Theradiag.

Under the terms of the agreement, Theradiag will receive an initial fee followed by additional payments if future tests are licensed. Theradiag will sell raw materials to MLS and will receive royalties on MLS’ sales in the U.S.

¹ Epidemiology of IBD in the US, Datamonitor 2015

About Theradiag

Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag notably markets the Lisa Tracker® range (CE marked), which is a comprehensive multiparameter therapeutic drug monitoring solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of rectal cancer, auto-immune and inflammatory diseases and HIV/AIDS. Theradiag is thus participating in the development of customized treatment, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 75 employees. For more information about Theradiag, please visit our website: www.theradiag.com

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