April 25, 2019
Ohara Pharmaceutical Co., Ltd.
License and Joint Development Agreement on
Novel Biliary Tract Cancer Treatment

Ohara Pharmaceutical Co., Ltd. (Head office: Shiga, Japan; CEO: Seiji
Ohara; hereinafter, “Ohara”) has entered into a license and joint
development agreement with J-Pharma Co., Ltd, dated April 25, 2019
regarding the novel compound JPH203. (Head office: Kanagawa, Japan;
Representative Director and Chairman: Hitoshi Endou, M.D., Ph.D;
Representative Director and President: Masuhiro Yoshitake; hereinafter,“J-Pharma”).
With the execution of this agreement, Ohara has obtained the exclusive
right to research, develop, commercialize and manufacture JPH203 forthe treatment of advanced biliary tract cancer in Asia, including Japan andChina, as well as Africa. To secure these rights, Ohara will pay J-Pharma
development milestone fees and royalty payments. In addition, Ohara will
support a capital increase by J-Pharma through participation in athird-party allotment of shares to be issued by J-Pharma.
JPH203 is a novel low-molecular compound that induces apoptosis oftumor cells by selectively inhibiting L-type amino acid transporter-1(LAT1), which is specifically expressed in tumor cells, and by inhibiting theuptake of amino acids through LAT1. In phase I clinical trial in patientswith advanced solid tumors, JPH203 was well-tolerated anddemonstrated potential efficacy for biliary tract cancer. A phase II clinical
trial for advanced biliary cancer is currently ongoing.
Ohara is actively expanding its development pipeline to address unmet
medical needs in Japan, and this strategic alliance with J-Pharma is a partof these initiatives. Ohara will promote the development of JPH203, sothat products can be provided to patients suffering from biliary tract
cancer as soon as possible.

[About Ohara Pharmaceutical Co., Ltd.]
Ohara Pharmaceutical Co., Ltd. is a pharmaceutical company focusing on
the businesses of orphan drugs and generic drugs. Its mid-term 3-yearbusiness plan started in FY2018 under the catchphrase “Challenge 2020,”
with the key objective of “addressing unmet medical needs,” to advance
management innovations and make the next leap forward. The company
focuses on the development and marketing of orphan drugs mainly in thefield of pediatric oncology and on the development, manufacture andmarketing of generic drugs that give extra consideration to the preventionof medical accidents. Ohara plans to further expand these businesses into
emerging countries, primarily in the Asian and African regions.

[About J-Pharma]
J-Pharma is a venture company that aspires to contribute the drug
discovery that targets “Transporter” proteins, which mainly exist in cell
membrane and have function as transmembrane substance transporters.
As there are now only a few drugs that target transporters, the mission ofJ-Pharma is to focus on drug discovery targeting such transporters, andto establish a robust integrated portfolio of drugs and diagnostics basedon pioneering research on transporters. The company currently promotes
the development of anticancer drugs JPH203 and OKY-034, which target
LAT1, as well as the novel PET diagnostic, NKO-028.
For details, please visit: http://www.j-pharma.com.

[About the amino acid transporter LAT1]
Amino acid transporters exist in normal cells as nutrition transporters thattransport extracellular nutrients into the cell interior. LAT1 is one suchamino acid transporter that is selectively and highly expressed in tumorcells, and transports large neutral amino acids, including many essential
amino acids. It has been reported that the expression of LAT1 is increasedin many forms of cancer, such as cancers of the colon, lung, prostate,
stomach, biliary tract, pancreas, kidney, pharynx, esophagus and brain
tumors, and that patient groups exhibiting high LAT1 expression have apoor prognosis in biliary tract and pancreatic cancers.
[About biliary tract cancer]
The number of deaths due to biliary tract cancer in Japan is approximately
18,000, and has been increasing in recent years.1) On the other hand, asecond-line chemotherapy that is recommended for patients with biliary
tract cancer who have no response to the standard chemotherapy has yetto be established and there is a high, unmet need for a second-line
chemotherapy.2)

1)

Vital Statistics (Vital Health and Social Statistics Office to the Counsellor for Vital, Health and Social
Statistics to the Director-General for Statistics and Information Policy, Ministry of Health, Labour andWelfare) Cancer Mortality (1958-2016)

2)

Clinical practice guidelines for management of biliary tract cancers, edited by the Publishing committee ofthe evidence-based clinical practice guidelines for the management of biliary tract cancers, JapaneseSociety of Hepato-Biliary-Pancreatic Surgery

Contact details for inquiries regarding this issue:
Takahiro Iyo, Representative Executive Director and CFO
Yutaka Hayakawa, D.V.M, Ph.D., Director, Research and Development Division
Ohara Pharmaceutical Co., Ltd.
Tel: +81-(0)3-6740-7701 FAX: +81-(0)3-6740-7702