To all persons concerned
November 14, 2018
Ohara Pharmaceutical Co., Ltd.
Adoption as a Practical Realization Development Type of
the Cyclic Innovation for Clinical Empowerment bythe Japan Agency for Medical Research and Development

Ohara Pharmaceutical Co., Ltd. (Head Office: Koka-shi, Shiga Japan; CEO: Seiji
Ohara; hereinafter, referred to as “Ohara”) is pleased to announce that on
October 16, 2018, our development plan for the practical application of OP-724,
a drug for the treatment of hepatic cirrhosis caused by hepatitis B and C viruses
infection, was adopted by the public offering project of the Japan Agency for
Medical Research and Development (hereinafter, referred to as “AMED”), as apractical realization development type in the general-type of the (3rd) “CyclicInnovation for Clinical Empowerment (hereinafter, referred to as “CiCLE”)” inFY2018.
CiCLE, which is implemented by AMED, is a project that mobilizes all of Japan’s
capabilities through industry-academia-government collaboration, with the aim ofpromoting the implementation of research and development that responds
appropriately to medical needs, establishing infrastructure (including humanresources) that fundamentally innovates acceleration of the practical realizationof drug discovery, and creating an environment that strongly promotes open
innovation and venture development in the field of medical research anddevelopment.
An overview of the practical realization development type that has been adopted
by the AMED on this occasion is as follows:
・ Project title: Research and development of an innovative antifibrotic drug that
improves the life prognosis of hepatic cirrhosis
・ Representative company: Ohara Pharmaceutical Co., Ltd.
Website of AMED related to the adoption of CiCLE projects (Japanese only):https://www.amed.go.jp/koubo/07/01/0701C_00001.html
Following this adoption for CiCLE by AMED, Ohara will accelerate thedevelopment of OP-724, so that it can be provided to patients who are sufferingfrom hepatic cirrhosis without further delay.

【About OP-724】
OP-724 is a compound developed by PRISM BioLab (PRISM BioLabDevelopment Code: PRI-724), which acts as a CBP/beta catenin antagonist thatinhibits activation of the Wnt/beta-catenin signaling pathway. Although it wasoriginally developed as an anticancer drug, a study performed at the Tokyo
Metropolitan Institute of Medical Science using a hepatic cirrhosis mouse model
independently developed by the Institute confirmed that OP-724 displays
antifibrotic effects, resulting in an improvement in hepatic histology. Based onthese findings, an investigator-initiated phase I clinical trial has been completed
in patients with hepatic cirrhosis in Japan, at the Tokyo Metropolitan Cancer andInfectious Diseases Center Komagome Hospital, with the support of theAcceleration of Transformative Research for Medical Innovation (ACT-M) ofAMED Medical Research and Development Programs Focused on TechnologyTransfer. Currently, an investigator-initiated clinical trial is underway which iscentered on the Tokyo Metropolitan Cancer and Infectious Diseases Center
Komagome Hospital, with development support provided by the Kyushu
University Center, as Seeds C in the AMED Bridging Research Accelerating
Network Program. On May 24 of the current year, Ohara in-licensed thedevelopment and commercialization rights of OP-724 from PRISM BioLab, andis currently leading its development in Japan. With the support of many medicalinstitutions, Ohara will endeavor to promote the further development of OP-724,
in order to promptly obtain marketing authorization for the treatment of hepaticcirrhosis caused by hepatitis B and C viral infections.

Contact details for inquiries regarding this issue:
Takahiro Iyo, Representative Executive Director and CFO
Yutaka Hayakawa, D.V.M, Ph.D., R&D Division Managing Executive Officer
Ohara Pharmaceutical Co., Ltd.
Tel: 03-6740-7701

FAX: 03-6740-7702