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Agreements

Date: 2017-03-28

Type of information: Licensing agreement

Compound: LISA TRACKER® monitoring assays

Company: Theradiag (France) Miraca Life Sciences (USA - TX)

Therapeutic area:

Type agreement: licensing

Action mechanism: theranostic test

Disease:

Details:

  • • On November 18, 2015, Theradiag announced a strategic licensing agreement with Miraca Life Sciences 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. Under the collaboration, Theradiag will grant  Miraca Life Sciences an exclusive know-how license for the validation, commercialization and promotion in the U.S. of therapeutic drug monitoring assays. Under the agreement,  Miraca Life Sciences will conduct validation studies and market therapeutic drug monitoring tests throughout the U.S. via its specialized sales force.  Miraca Life Sciences also will promote therapeutic drug monitoring testing with key opinion leaders, laboratories and other advocates in the U.S. healthcare field.

Financial terms:

  • 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 Miraca Life Sciences' sales in the U.S.

Latest news:

  • • On March 28, 2017, Theradiag announced further progress in bringing its LISA TRACKER® monitoring tests to the US market as part of its agreement with Miraca Life Sciences.The Simponi® (golimumab) monitoring kit supplements the InformTx ™ range and increases to six the number of tests available in the US market for biotherapies treating inflammatory bowel disease .
  • • On December 1, 2016, Theradiag announcing the launch of its Stelara® (ustekinumab) monitoring test in the US market, as part of its partnership with Miraca Life Sciences. Theradiag’s Stelara® monitoring kit expands Miraca Life Sciences’ InformTx™ service in the US market, allowing monitoring of biotherapies for the treatment of inflammatory bowel disease. InformTx™ now features five Theradiag monitoring tests. Miraca Life Sciences started marketing and promoting the service in June 2016, initially with four tests (see below).
  • • On June 16, 2016, Theradiag announced that four tests from its LISA TRACKER® range have been launched in the US market,under the licensing agreement with Miraca Life Sciences that was announced in November 2015. Miraca Life Sciences will start to market and promote four tests under the name “InformTx™” that utilize technology and raw materials from Theradiag's LISA TRACKER® range. These four biotherapy monitoring tests (infliximab/Remicade®, adalimumab/Humira®, certolizumab/Cimzia® and vedolizumab/Entyvio®) deal mainly with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis.  It is estimated more than 330,000 IBD patients in the United States are treated with biologics, twotimes more than in Europe. Theradiag will sell the required materials and will receive royalties on Miraca Life Sciences' sales in the USA.

Is general: Yes