INS.L Regulatory News (INS)

Instem plc

("Instem" or the "Company")

Two contract wins in Asia-Pacific

Instem (AIM: INS.L), a leading provider of IT solutions to the global early development healthcare market, announces that it has won two new contracts in the Asia-Pacific region.

The first is a five-year contract with the National Shanghai Center for Drug Safety Evaluation and Research (NCDSER), a leading Chinese Contract Research Organisation (CRO), which has purchased Instem's integrated Provantis® pre-clinical software suite to automate laboratory processes at their R&D facility in Shanghai, China.

The contract was awarded following a detailed competitive evaluation and is of significant strategic importance as it strengthens the Company's foothold in the Asia-Pacific region. Instem's Provantis solution, which is increasingly being recognised as the industry standard within China and the leading solution around the world, will replace a combination of in-house developed applications and legacy systems to provide streamlined processes. It will be delivered using the SaaS delivery model from Instem's Shanghai-based data center, adding another large and prestigious laboratory to Instem's established hosting data centre client roster.

Commenting on the agreement, Professor Jing Ma, Executive Director at NCDSER, said: "We are extremely pleased to be deploying Provantis at our Shanghai facility. We recognise that Instem and Provantis have fast become the gold standard within China and we look forward to joining the expanding Provantis user community within China and across the globe."

A second contract has been signed with an unnamed, leading Multi-national Corporation, which has purchased Instem's submit™ solution suite to support Clinical Data Interchange Standards Consortium's (CDISC) Standard for Exchange of Nonclinical Data (SEND).

SEND defines the organisation, structure, and format of standard non-clinical tabulation datasets for interchange between organisations such as sponsors and CROs and for submission to the US Food and Drug Administration (FDA). Guidance by the FDA was released earlier in 2014, paving the way for SEND to become a requirement with pre-clinical study submissions.

The submit™ solution, which was launched in 2005 and can be deployed as a traditional on-site system or accessed over the Internet using Instem's SaaS model, creates and manages SEND study datasets throughout their lifecycle and allows sponsors, CROs and regulators to share, visualise and analyse study data more efficiently.

Phil Reason, CEO of Instem, said: "We are delighted to have signed these two agreements in the Asia-Pacific territory. NCDSER is a recognised centre of excellence within Asia-Pacific and the contract is of significant strategic importance in terms of extending our presence within the region. Further to this, the contract with a leading Multi-national corporation illustrates the fact our cutting edge technology is being adopted by an increasing number of respected industry players."

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About Instem

Instem is a leading supplier of IT applications to the early development healthcare market delivering compelling solutionsfor data collection, management and analysis across the R&D continuum. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organisations for data-driven decision making leading to safer, more effective products.

Instem's portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledgethrough the extraction and harmonisation of actionable scientific information.

Instem supports over 400 clients through full service offices in the United States, United Kingdom and China with additional locations in India and a full service distributor based in Japan.

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

About the National Shanghai Center for Drug Safety Evaluation and Research (NCDSER)

Founded in 1993, NCDSER, also known as Shanghai InnoStar Bio-Tech Co. Ltd., is a leading pre-clinical Contract Research Organisation (CRO) based in China. As the first CFDA-certified GLP laboratory and the most comprehensive and experienced Chinese toxicology CRO, NCDSER has submitted numerous high quality safety evaluation studies and IND packages to both CFDA and US FDA. Since being certified by CFDA in 2003, NCDSER has evaluated a total of 506 compounds, including 417 small molecules, 72 biologics and 17 TCMs.

NCDSER is experienced in designing studies following the guidelines of different international regulatory authorities including FDA, OECD and CFDA.

NCDSER serves 300+ clients across North America, Europe and Asia.

More information: http://www.innostarsh.com/enabout.asp