Food and Drug Administration (FDA) and Clarivate Extend Material Transfer Agreement for Three Additional Years

Partnership enables agency-wide access to OFF-X translational safety intelligence solution

LONDON, May 23, 2023 /PRNewswire/ -- Clarivate Plc (NYSE: CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the extension of the Material Transfer Agreement (MTA) with the FDA for an additional three years. The extension will ensure continued agency-wide access to OFF-X™ by Clarivate, which provides integrated preclinical toxicity, clinical and post-marketing adverse event data, visualizations and analytics.

The success of clinical research can be jeopardized by unexpected safety issues. It is critical to identify potential safety liabilities as early as possible in the drug research and development (R&D) process. A translational approach to drug safety data can reduce patient burden and support increased success by harmonizing preclinical and clinical data.

As the collaboration enters its sixth year, the FDA will continue using OFF-X as a solution to identify potential adverse events associated with molecular targets and new and marketed drugs and its utility in the regulatory review process. The agreement enables the continued support of the FDA's mission of protecting public health by evaluating approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets.

Gavin Coney, Vice President, Partnerships at Clarivate, said: "Clarivate draws on in-depth data, insights and expertise to enable life science partners to anticipate and overcome barriers to delivering innovative treatments to patients. The agreement between the FDA and Clarivate will enable increased preparedness as researchers and drug safety professionals look to anticipate and monitor potential safety liabilities across all phases of drug R&D and post market."

OFF-X covers targets and drugs in all stages of R&D from emerging targets and first-in-class therapies to those that have reached the market. OFF-X helps to promptly identify toxicology and safety liabilities, de-risk R&D programs and facilitate the analysis of pharmacovigilance signals. Updated daily with expertly curated safety data from multiple origins, the portal covers a range of over 15,000 targets and more than 32,000 drugs & biologics and is populated with over 2 million expertly curated safety alerts associated to 12,000+ adverse effects and toxicity endpoints.

About FDA/CDER

FDA/CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. FDA/CDER's mission is to protect and promote public health by helping to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients.

About Clarivate

Clarivate™ is a leading global information services provider. We connect people and organizations to intelligence they can trust to transform their perspective, their work and our world. Our subscription and technology-based solutions are coupled with deep domain expertise and cover the areas of Academia & Government, Life Sciences & Healthcare and Intellectual Property. For more information, please visit www.clarivate.com.

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