To all persons concerned
April 26, 2019
Ohara Pharmaceutical Co., Ltd.
Announcement of the signing of a joint R & D agreement andcommencement of development activities regarding“Research and development of innovative antifibrotic drugs
to improve the life prognosis of cirrhosis”

Ohara Pharmaceutical Co., Ltd. (Head Office: Koka-shi, Shiga Japan; CEO: Seiji
Ohara; hereinafter, referred to as “Ohara”) announced the commencement ofresearch and development activities for the its drug candidate OP-724 for thetreatment of cirrhosis caused by hepatitis C and B. This research anddevelopment project was adopted as a practical realization development type in
the general-type of the (3rd) “Cyclic Innovation for Clinical Empowerment(hereinafter, referred to as “CiCLE”)” in year 2018 (Heisei 30), sponsored bythe
Japan Agency for Medical Research and Development (hereinafter, referred toas “AMED”). At present, we will conclude a joint research and development
commission contract agreement between our company and each research
execution organization, and will proceed under industry-government-academia
collaboration.
The two key goals of this activities are as listed below, with the ultimate goal ofobtaining regulatory approval for the use of OP-724 as a treatment for cirrhosis.
・ Confirmation of the treatment concept based on the antifibrotic action of OP724
・ Practical application of non-invasive fibrotic markers that lead to clinicalendpoints of liver cirrhosis
Going forward, Ohara will lead the implementation of non-clinical and clinicalstudies, with the support of the following research institutions who will collaborate
to conduct basic research and clinical research to search for non-invasive
markers of liver fibrosis.
・Metropolitan Cancer and Infectious Diseases Center Komagome Hospital・Tokyo Metropolitan Institute of Medical Science
・National Center for Global Health and Medicine
・National University Corporation Kyushu University
・National University Corporation Kanazawa University

【About OP-724】
OP-724 is a CBP/beta-catenin antagonist that inhibits the activation of theWnt/beta-catenin signaling pathway (PRISM BioLab Co., Ltd. development code:PRI-724). OP-724 was originally developed as an anticancer drug, but a study at
the Tokyo Metropolitan Institute of Medical Science using a liver cirrhosis mousemodel independently developed by the institute confirmed that OP-724 has
antifibrotic effects showed improvement in liver histology. The study wasconducted with the support of the Acceleration of Transformative Research for
Medical Innovation (ACT-M) Basic Scheme sponsored by the AMED. An
investigator-initiated phase I clinical trial wascompleted in patients with livercirrhosis in Japan. The study was conducted at the Tokyo Metropolitan Cancerand Infectious Diseases Center Komagome Hospital. Currently, an investigatorinitiated clinical trial is underway which is centered 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 AMEDBridging Research Accelerating Network Program.
We obtained development rights to OP-724 from PRISM BioLab Co., Ltd. on May
24th of this year and are now continuing the development efforts originally led by
PRISM BioLab Co., Ltd.

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

FAX: 03-6740-7702