ONO PHARMACEUTICAL Selects Medidata to Power Clinical Trials Exploring Additional Cancer Indications for Immunotherapy Drug OPDIVO® (nivolumab)

ONO PHARMACEUTICAL Selects Medidata to Power Clinical Trials Exploring Additional Cancer Indications for Immunotherapy Drug OPDIVO® (nivolumab)

Japan-Based Pharma Deploys Medidata Rave® to Capture, Manage and Report Patient Data for Clinical Trials Testing OPDIVO Against Broad Range of Cancers

January 26, 2016 05:30 PM Eastern Standard Time

NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, announced today that ONO PHARMACEUTICAL CO., LTD. ("ONO") has expanded its adoption of the Medidata Clinical Cloud® to include all clinical trials testing the use of OPDIVO® (nivolumab) against a broad range of cancers. The Japan-based company will leverage Medidata's industry-leading electronic data capture and management technology (Medidata Rave®) to evaluate additional indications for OPDIVO, a cutting-edge immunotherapy drug that was initially approved to treat metastatic melanoma.

OPDIVO is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and provides anti-tumor activity across malignant tumors.

"At ONO, we are pushing medical and scientific frontiers with the goal of making patients' lives better," said Satoru Fukimbara, Ph.D., Manager of Data Science Department, Clinical Development Division. "Working with Medidata, we've been able to demonstrate the efficacy of OPDIVO for a select group of aggressive cancers. Now, we look forward to expanding use of the Medidata platform as we further explore the potential for immunotherapy to transform oncology care."

OPDIVO, which ONO is co-developing under license agreement with Bristol-Myers Squibb (BMS), works by enabling the patient's immune system to better attack cancer cells. The immunotherapy—the first PD-1 immune checkpoint inhibitor used to treat cancer—was initially approved in Japan and the US in 2014 for patients with extremely poor prognoses for unresectable or metastatic melanoma. In 2015, OPDIVO was approved for untreated advanced-stage malignant melanoma, non-small cell lung cancer (NSCLC) and advanced-stage renal cell carcinoma in the US, as well as for malignant melanoma and advanced squamous cell lung cancer in Europe. OPDIVO also recently received a manufacturing and marketing partial amendment approval for treating patients with unresectable, advanced or recurrent NSCLC in Japan.

To strengthen its immuno-oncology portfolio and address the unmet medical needs of cancer patients worldwide, ONO is embarking on a series of clinical trials in Japan to assess the safety and efficacy of using OPDIVO for a wide range of additional indications, including head and neck cancer; gastric and esophageal cancer; urothelial cancer; hepatocellular carcinoma; Hodgkin's lymphoma and Glioblastoma, among others.

A Medidata customer since 2012, ONO utilizes Rave to support its Phase II and III clinical trials in oncology, cancer anorexia/cachexia and diabetes. ONO's R&D team has used Medidata technology to improve operational efficiencies, enhance workflows and accelerate overall study timelines throughout the drug development process. ONO will now exclusively use Rave as its enterprise EDC solution for current and upcoming OPDIVO-focused trials.

"Cancer immunotherapy is one of the most exciting and fastest growing areas of medical research and we're proud to work with ONO, a true pioneer in this field," said Takeru Yamamoto, Medidata's managing director of the Asia-Pacific region. "Our cloud technology platform will give ONO more actionable information and more insight into how patients with various cancers are responding to OPDIVO. It's a critically important tool to help ONO achieve its goal of developing more and better treatment options for cancer patients around the world."

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About ONO PHARMACEUTICAL CO., LTD.

ONO PHARMACEUTICAL CO., LTD., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the diabetes and oncology areas. For more information, please visit the company's website at http://www.ono.co.jp/eng/index.html.

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.

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