Press Release

Japanese Biotech JCR Pharmaceuticals Selects Medidata’s Cloud-Based Platform to Power Rare Disease Clinical Research in Japan

06/24/2015

Innovative Specialty Biopharma Adopts Medidata Technology to Bring Operational Efficiencies and Greater Speed to Cutting-Edge Research on Fabry Disease

NEW YORK, N.Y. – June 24, 2015 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that its cloud-based technology platform has been adopted by JCR Pharmaceuticals Co., Ltd. The Japanese pioneer in biotherapeutics is leveraging the Medidata Clinical Cloud® to support research on a therapy for the treatment of Fabry disease, bringing greater speed and operational efficiencies to the organization’s development program in Japan.

With a primary focus on biotherapeutics that use recombinant DNA (rDNA) technology to address significant unmet medical needs, JCR Pharmaceuticals is developing therapeutic enzymes to treat lysosomal storage diseases (including Fabry disease), a group of rare genetic diseases that occur in very small patient populations.  For its clinical study on a Fabry disease treatment, JCR Pharmaceuticals has selected Medidata’s cloud-based technology for electronic data capture and management (Medidata Rave®) to streamline clinical trial operations.

“Fabry disease is an inherited and progressive condition, with approximately 5,000-10,000 diagnosed patients in the world and 300 in Japan alone,” said Hideaki Hirai, data science group manager, clinical intelligence department, development division, JCR Pharmaceuticals. ”The broad adoption of Medidata’s cloud-based technology solutions, including Rave, across Japan allows us to be agile in our studies and efficient with our resources, while ensuring investigator engagement in our research efforts. We look forward to better data and faster trials—which our partnership with Medidata is enabling—and working together to quickly deliver a value-added treatment option to Fabry patients in need.”

Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific region, said, “With more and more sponsor companies adopting Medidata Rave for their clinical trials, investigators and CRCs (clinical research coordinators) are increasingly able to quickly and efficiently begin using the technology at sites across Japan. By incorporating the Medidata platform into its research program, JCR is helping to modernize the field of rare and orphan disease drug development while ensuring investigative sites remain engaged. We’re proud to partner with such a forward-thinking organization and support its longstanding commitment to developing valuable treatment options for under-served patient communities around the world.”

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About JCR Pharmaceuticals Co., Ltd. (JCR)
JCR (TSE 1st Section, Code: 4552) is a specialty pharma engaged in the research, development, manufacture and marketing of biopharmaceuticals and regenerative medicine with a focus on rare diseases. Its philosophy, “Contributing towards people’s healthcare through pharmaceutical products” drives JCR to create innovative pharmaceutical products as value-added treatment options for the under-served patient community.

About Medidata
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

JCR Pharma contact
Corporate Strategy Department: ir-info@jcrpharm.co.jp

Medidata Contacts
Investor: Hulus Alpay, Medidata Solutions, +1 212-419-1025, halpay@mdsol.com
Media Contact – Americas & EMEA: Nicole Pariser, Medidata Solutions, +1 212-659-1069, npariser@mdsol.com
Media Contact – APAC: Masako Ishida, Medidata Solutions, +81 3-4588 0400, mishida@mdsol.com