Life Technologies to Collaborate with Merck Serono for Companion Diagnostics Development and Commercialization
17 Jul 2013

Life Technologies Corporation today announced that the company has signed an agreement to collaborate with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for current and future companion diagnostics projects. The current agreement constitutes the first collaboration between the two companies and represents another step in Life Technologies’ strategy to develop its diagnostic business through internal development, collaborations and select acquisitions.

The non-exclusive agreement covers an initial project for oncology and provides for a long-term collaboration across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas. Financial terms of the agreement were not disclosed.

“Life Technologies’ combination of platforms and capabilities are unique in the companion diagnostics space, particularly in oncology,” said Ronnie Andrews, President, Genetic & Medical Sciences at Life Technologies. “With our recent acquisition of Compendia Bioscience, we possess bioinformatics solutions and cancer biomarker expertise to collaborate with pharma on each phase of the drug development process, from biomarker hypothesis to assay development concurrently with drugs to approved diagnostic tests.”

“By helping pharma target the right cancer patients in clinical trials,” said Andrews, “we believe that we have the potential to rapidly accelerate cancer drug development and this is good for everyone – for Life Technologies and our pharma partners, and most importantly, for patients.”

The collaboration will seek to combine the biomarkers identified by Merck’s translational research with Life Technologies’ proprietary platform technologies and to develop companion diagnostics concurrently with Merck’s drug development programs. The collaboration will also work to simultaneously seek regulatory approval of Merck’s drug and Life Technologies’ companion diagnostic. Life Technologies offers a variety of platform technologies that support the development of new diagnostics. These technologies span both genetic and proteomic analysis, including next-generation sequencing, Sanger sequencing, qPCR and flow cytometry, some of which have already received clearance by the Food and Drug Administration (FDA). If successful, the agreement will be followed by a commercialization agreement under which Life Technologies will commercialize the companion diagnostic in agreed upon territories.

“Life Technologies is uniquely positioned to provide pharma a flexible, cost effective means to manage the evolution of the of companion diagnostic assays through the drug development process,” said Andrews.

According to FDA, a companion diagnostic is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapy. In 2011, the FDA released draft guidance addressing the use of companion diagnostics in clinical development and the review and approval process for diagnostics and associated new therapies.1 In addition the European Medicines Agency (EMA) has recently announced it is updating the guideline on evaluation of anticancer medicines to include companion diagnostics.2

References
1. Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices, Issued July 14, 2011. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262292.htm, accessed 15 March 2013
2. European Medicines Agency updates guideline on evaluation of anticancer medicines, 11 January 2013. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/12/news_detail_001679.jsp&mid=WC0b01ac058004d5c1, accessed 15 March 2013

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