Celltrion and Medidata

Worldwide Leader in Biosimilars Development Adopts Medidata’s Cloud Based Technology to Enhance Clinical Research Programs for Ailments Including Rheumatoid Arthritis, Respiratory Diseases and Cancer

NEW YORK, N.Y. and SEOUL, KOREA – January 20, 2016 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, and Korean biopharmaceutical company Celltrion (KOSDAQ: 068270) today announced that the Seoul-based organization has adopted Medidata's industry-leading technology platform. A global leader in biosimilars R&D, Celltrion will rely on the Medidata Clinical Cloud^® to enhance the speed, efficiency and accuracy of its clinical trials.

“Celltrion conducts more multi-regional clinical trials than any other life sciences company in Korea, and Medidata will provide powerful and scalable technology to ensure the success of our biosimilars development programs,” said Sang-Joon Lee, Celltrion’s vice president. “Celltrion is researching the therapeutic impact of large and complex molecules, which, by their very nature, involve numerous complicated clinical trials. This makes it even more important for us to have flexibility and simplicity in our research technology platforms. That is exactly what Medidata’s cloud-based technology will provide. We believe Medidata can help Celltrion in its effort to accelerate and expand access to advanced therapeutics for patients around the world.” 

Celltrion specializes in the research, development and manufacturing of biosimilars and innovative treatments for a number of chronic diseases, including rheumatoid arthritis, respiratory disease and cancers. Celltrion strives to provide more affordable biosimilar monoclonal antibodies (mAbs)-which are designed in the laboratory to produce the same effects as natural antibodies-to patients with limited access to advanced therapeutics. By partnering with Medidata’s professional services team and implementing its cloud-based technology for electronic data capture and management (Medidata Rave^®), medical coding (Medidata Coder^®) and randomization and trial supply management (Medidata Balance^®), Celltrion is enhancing its in-house data management capabilities and the operational efficiencies of its biosimilars clinical trials.

“Our technology will provide Celltrion with unmatched visibility into the direction and success of its growing pipeline worldwide,” said Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific (APAC) region. “The life sciences industry is rapidly growing in Asia, especially in the burgeoning field of biosimilars, and Medidata is excited to be partnering with a company like Celltrion that is at the forefront of this growth.” 

About Celltrion

Celltrion, headquartered in Korea is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion previously received EMA approval for Remsima^® which is the world’s first biosimilar mAb to receive approval from a regulatory agency in a developed country.

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.