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Company News: Molecular Health Licenses SafetyMAP™ to the U.S. Food and Drug Administration (FDA)

Molecular Health has entered into a commercial license to provide the FDA with use of its SafetyMAP^TM software – formerly known as Molecular Analysis of Side Effect information (MASE^TM), to provide a comprehensive and dynamic analytical solution for the detection and molecular analysis of drug-induced adverse events for all marketed drugs and for predicting safety issues of new drug candidates.  The license supplies the FDA with access to SafetyMAP for 10 concurrent users for a period of one year and can be extended for two additional years at the discretion of the FDA.

Lutz Voelker, CEO of Molecular Health said, “This FDA User License validates the importance of having the robust drug safety analytics that Molecular Health’s SafetyMAP uniquely provides.”

Following the acceptance of a proposal submitted in response to the FDA’s Request for Quotation, RFQ-1146774, “Molecular Health User Licenses for MASE (or Equal)”, Molecular Health and the FDA entered into a commercial license agreement. Prior to issuing the RFQ, the FDA had been evaluating this technology under the terms of a five-year research collaboration agreement with Molecular Health that began in 2012.

The FDA described in its RFQ the important capability that Molecular Health’s technology provides:

Drug safety prediction and the evaluation of post-marketing signals depend on the ability to find scientific data that can confirm relationships among drugs, drug targets, toxicity mechanism, patient susceptibility and clinical response. This requires the ability to interrogate a wide variety of data sources, including the FAERS database, MEDLINE, gene and protein databases, FDA drug product labels, patents and other document repositories to uncover hidden relationships between scientific findings and adverse events. The creation of molecular target adverse event profiles is advancing safety science. This capability is mission critical for assessing the importance of possible safety issues pre- and post-approval and for supporting our regulatory science mission at FDA.  Over the past three years we have been using the MASE platform to achieve the goals outlined above.  A large number of FDA safety issues have been evaluated and labeled using MASE data mining capabilities.  This software has provided valuable, accurate and reliable information [emphasis added].

Leveraging Molecular Health’s platform technology of biomedical and molecular databases, analytical methods and visualization tools, SafetyMAP was developed by integrating clinical information from five million adverse event reports (FAERS), with molecular information about targets and drug mode action at the level of target pathways.  This drug-centric data integration process enables the molecular transformation of clinical information, such that human clinical information can now be analyzed from the perspective of molecular parameters (e.g., targets or pathways).

Molecular Health is also marketing SafetyMAP to the pharmaceutical industry and to pharmacy benefit managers.