February 15, 2019
Ohara Pharmaceutical Co., Ltd.
License Agreement on Novel Gliomas Treatment
Ohara Pharmaceutical Co., Ltd. (Head office: Shiga, Japan; CEO: Seiji
Ohara; hereinafter, “Ohara”) has entered into a license, development andcommercialization agreement in Japan dated January 29, 2019
concerning the novel compound ONC201 (Development No. OP-10) with
Oncoceutics, Inc. (Head office: Philadelphia, PA, USA; CEO: Wolfgang
Oster; hereinafter, “Oncoceutics”).
In this agreement, Ohara has acquired not only the license for thedevelopment and commercialization of ONC201 in Japan, but also theright of first refusal of ONC 201 in China, Asia and West Africa, and theright of first refusal of next generation compound ONC 206 in Japan,China, Asia and West Africa. In return for the license and future rights,
Ohara will make a multi-part payment to Oncoceutics including upfront
payments, milestone payments, payment for purchase of the drug forre-sale, and royalties. In addition, Ohara will make a significant equity
investment into Oncoceutics.
ONC 201 is a novel small molecule compound that acts as an antagonist
to the dopamine D 2 receptor and leads to tumor cells to apoptosis.
ONC201 has demonstrated anti-cancer activity and safety in preclinicalmodels and in several ongoing clinical trials, including clinical trials inadult and pediatric patients with high grade gliomas ＊1. In November
2018, the US Food and Drug Administration (FDA) has granted Fast Track
Designation ＊ 2 to ONC 201 for the treatment of adult recurrent
H3K27M-mutant high-grade glioma.
Ohara will advance clinical development in Japan so that ONC 201 canbe delivered as a new treatment option to patients with H3 K27M-mutant
high-grade glioma.

Ohara Pharmaceutical Co., Ltd.

[About Ohara Pharmaceutical Co., Ltd.]
Ohara Pharmaceutical Co., Ltd. is one of the few Japanesepharmaceutical companies that engage in both the orphan drug andgeneric drug business. Its 3-year “Challenge 2020” business plancommenced in fiscal 2018, with one key objective of this plan being tochallenge and address unmet medical needs. The company develops andmarkets orphan drugs mainly in the field of pediatric oncology and also
operates an innovative generic drug business which takes carefulconsideration to prevent medical accidents. Ohara Pharmaceutical Co.,
Ltd. plans to further expand these businesses into emerging countries,
primarily in the Asian region.
[About Oncoceutics, Inc.]
Oncoceutics, Inc. is a clinical-stage drug discovery and development
company with a novel class of compounds, called “imipridones,” that
selectively target G protein-coupled receptors for oncology. The first leadcompound to emerge from this program is ONC201, an orally active small
molecule DRD2 antagonist. The company is supported by grants from NCI,
FDA, Musella Foundation, XCures, Cancer Commons, and a series ofprivate and public partnerships.
For details, please visit: http://oncoceutics.com/＊1：Glioma is a generic term for tumors arising from numerous glial cells
existing in the brain / spinal cord. The number of new annual
patients in Japan is approximately 4,000 to 5,000 people. Among
gliomas, Diffuse midline glioma, H3K27M-mutant is WHO grade IV
and has a very low survival rate.
＊2：Fast Track Designation is a system whereby FDA preferentially judges
new drugs with high necessity.

Contact details for inquiries regarding this issue:
Takahiro Iyo, Representative Executive Director and CFOYutaka Hayakawa, D.V.M, Ph.D., R&D Division Managing Executive Officer
Ohara Pharmaceutical Co., Ltd.
Tel: 03-6740-7701 FAX: 03-6740-7702

Ohara Pharmaceutical Co., Ltd.