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Life Technologies to Collaborate with Merck Serono for Companion Diagnostics Development and Commercialization
, July 16, 2013
/PRNewswire/ -- Life Technologies Corporation
(NASDAQ:LIFE - News
) 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
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
About Life Technologies
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions is secured by more than 5,000 patents and licenses that span the entire biological spectrum -- scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.
Life Technologies' Safe Harbor Statement
This press release includes forward-looking statements about Life Technologies' anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
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SOURCE Life Technologies Corporation