INS.L Regulatory News (INS)

4th April 2016

Instem plc

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

Four SEND related contract wins

Growing adoption of submit™ with maiden SEND related orders in Japan since incorporating the Tokyo office.

Instem plc (AIM: INS), a leading provider of IT solutions to the global early development healthcare market, announces four new contract wins for its submit™ solution suite and related consultation services, worth a combined value of over US$0.8 million.

Contract Wins

The largest of the four wins is with a global top ten pharmaceutical company, which is an existing Instem customer. The organisation has purchased Instem's entire submit™ solution suite with software licences being deployed immediately.

Two of the other three contracts are for companies in Japan developing new products that they anticipate submitting to the US Food & Drug Administration ("FDA") for regulatory approval. The remaining contract is with a leading Contract Research Organisation in China, which is already receiving requests from its clients regarding provision of SEND data sets at the conclusion of contracted studies.

In aggregate, all four contracts are comprised of a mixture of perpetual software licence fees, annual support and professional service fees. The combined total is in excess of US$0.8 million and will be largely recognised in the current financial year.

SEND Submit™

The FDA's SEND ("Standard for Exchange of Nonclinical Data") initiative was ratified in December 2014 and its implementation is now a market imperative for the entire drug development industry.

SEND experts at Instem, who have been instrumental in the development of the standard over the last 10 years, have been in high demand advising teams across the drug development community over the past 18 months on the implications of this new regulatory mandate. This frequently results in organisations implementing some, or all, of Instem's submit™ solution suite to create, manage, review, store and transfer SEND data for accurate submissions to the FDA, or to contract with Instem to convert their study data into fully compliant SEND data sets, ready for submission.

Phil Reason, CEO of Instem plc, commented; "We are delighted to have extended our relationship with a top ten global pharmaceutical company while securing our first SEND related contracts in Japan since incorporating an office in Tokyo in 2015. These contracts, plus the one in China, underpin our expectations for the Group for the year and further illustrate how Instem is cementing deeper, longer lasting relationships with its clients as the Company continues to benefit from the FDA mandate requiring pre-clinical study submissions to comply with SEND."

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About Instem plc

Instem is a leading supplier of IT applications to the early development healthcare market, delivering compelling solutions for 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 knowledge through the extraction and harmonisation of actionable scientific information.

Instem supports over 400 clients from offices in the United States, the United Kingdom, India, China and Japan, with an additional presence in France.

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