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2015-09-09

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

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| CAMBRIDGE, Mass., Sept. 9, 2015 (GLOBE NEWSWIRE) -- Molecular Health has |
|entered into a commercial license to provide the FDA with use of its |
|SafetyMAPTMsoftware - formally known as Molecular Analysis of Side Effect |
|information (MASETM), 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. |
| |
|About Molecular Health |
| |
| |
| |
|Molecular Health is a leading biomedical company that is transforming |
|molecular data and medical knowledge into actionable clinical information for |
|more efficient and safe targeted therapies for each individual patient. |
|SafetyMAPTMis a content and analytics solution for drug de-risking and drug |
|safety analysis, for research by regulatory authorities and the |
|pharmaceutical and health insurance industries. Molecular Health's |
|TreatmentMAPTMgenerates an individualized tumor analysis and clinical |
|interpretation for evidence-based targeted therapy identification based upon |
|published medical knowledge in a clinical context. This analysis is offered |
|in the U.S. utilizing an end-to-end CLIA laboratory test grounded in |
|next-generation sequencing technology. In Europe, Molecular Health's |
|TreatmentMAP is the first registered medical device of its kind for |
|personalized cancer medicine. Molecular Health Inc., headquartered in |
|Cambridge, Massachusetts, with a laboratory and support center in Greater |
|Houston, Texas, is a wholly owned subsidiary of Molecular Health GmbH, |
|headquartered in Heidelberg, Germany. To learn more, please |
|visit:www.molecularhealth.com. CONTACT: Media Contacts |
| |
| U.S.: |
| Mark Rodgers |
| 832-247-3068 |
| mark.rodgers@molecularhealth.com |
| |
| EU: |
| Carla Mertens |
| +49 6221 43851-2275 |
| carla.mertens@molecularhealth.com |
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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Molecular Health via Globenewswire

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