INS.L Regulatory News (INS)

Instem plc

 ("Instem", the "Group" or the "Company")

European Medicines Agency Research Grant

Instem plc (AIM: INS), a leading provider of IT solutions to the global life sciences market, announces that it has secured funding as part of a €2.5m European Medicines Agency ("EMA") grant - with the Company receiving c.12.5% of funds invested by the EMA.

As part of an industry and academic consortium of nine beneficiaries, funded by EMA and led by Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Instem is collaborating on a two-year research project to further investigate the mutagenicity of different classes of N-nitrosamines ("NAs"). Humans may be exposed to this class of organic chemical compounds by consuming certain foods, or through tobacco use. Some active pharmaceutical ingredients also carry NAs as impurities from production and/or storage or may cause their formation in the gastrointestinal tract. Consequently, NA related risk has become a focus for pharmaceutical and other regulatory authorities around the world. The project will aim to distinguish highly potent from less potent carcinogens.

Experts from Instem's In Silico Solutions group will be participating in the project, and its Leadscope Model Applier computational toxicology software suite and toxicity and carcinogenicity databases will be used to help the consortium develop novel in silico test systems that will improve risk assessment and derive reference doses such as acceptable intake values.

Renowned for its advanced informatics and prediction technology, together with comprehensive database solutions, Instem's in silico solutions enable organizations around the world to effectively unlock valuable knowledge contained in both public and proprietary sources of research data. Its clients can access over 500,000 toxicology studies for more than 200,000 chemicals, enabling fast, accurate, defendable and regulatory-accepted predictions.

Dr. Glenn Myatt, VP Informatics, Instem commented: "The Leadscope Model Applier software solution includes a comprehensive package of models to meet the growing market demand for in silico solutions. The award of this grant highlights the strength of our product suite, which supports the continued global demand for reliable alternatives to traditional testing methods - with industry and regulators alike increasingly recognizing the huge benefits of computational toxicology approaches.

"We are delighted to have been invited to contribute to this important research program and to have the opportunity to work with leading researchers in developing new testing methodologies to help reduce drug safety risks."

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About Instem

Instem is a leading provider of IT solutions & services to the life sciences market delivering compelling solutions for Study Management, Regulatory Submissions, Clinical Trial Acceleration, and Informatics-based Insight Generation.

Instem solutions are in use by over 700 customers worldwide, including all of the largest 25 pharmaceutical companies, enabling clients to bring life enhancing products to market faster. Instem's portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonisation of actionable scientific information.

Instem products and services address aspects of the entire drug development value chain, from discovery through to market launch. Management estimate that over 50% of all drugs on the market have been through some part of Instem's platform during their development.

To learn more about Instem solutions and its mission, please visit www.instem.com