ONO PHARMACEUTICAL : Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Additional Indications of Relapsed or Progressed Classical Hodgkin Lymphoma, Locally Advanced Unresectable or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma

October 30, 2017

ONO PHARMACEUTICAL CO., LTD. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") announced that ONO PHARMA TAIWAN CO., LTD. ("OPTW") received the supplemental approval of Opdivo® Intravenous Infusion 20 mg, 100 mg (Generic name: nivolumab; "Opdivo"), a human anti-human PD-1 (programmed cell death-1) monoclonal antibody, on October 27 from the Taiwan Food and Drug Administration (TFDA) in Taiwan, for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, those with locally advanced unresctable or metastatic urothelial carcinoma after failure of prior platinum-containing therapy, and those with unresectable or metastatic melanoma.

Classical Hodgkin lymphoma is a localized or diffuse malignant cell cancer derived from the lymphatic system, with an estimated about 190 patients* diagnosed annually in Taiwan. Urothelial cancer is the most common type of bladder cancer, with an estimated about 2,110 patients* diagnosed annually in Taiwan. The development of a new therapeutic drug has been currently expected for the treatment of patients with previously treated malignant tumor. Melanoma is a type of cancer that develops from the pigment-containing cells known as melanocytes having a capacity to produce melanin deeply related to skin color, with an estimated about 250 patients* annually in Taiwan. This approval allows Opdivo to be used for the treatment of patients with melanoma in combination therapy with ipilimumab (Yervoy®), a human anti-human CTLA-4 monoclonal antibody. While Opdivo has been approved as a mono-therapy for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma and disease progression following ipilimumab and a BRAF inhibitor, this approval also allows Opdivo to be used for the treatment of patients with previously untreated BRAF V600 mutation-positive melanoma.

OPTW is committed to taking measures necessary for proper use of Opdivo by collecting clinical data on the safety and efficacy of Opdivo, so that it can be properly used. In Taiwan, OPTW continues to market Opdivo under the co-promotion with Bristol-Myers Squibb (Taiwan) Ltd., based on the strategic collaboration agreement made between ONO and Bristol-Myers Squibb in July 2014.

*: Cancer Registry Annual Report, 2014 TAIWAN

Outline of Opdivo® Intravenous Infusion 20 mg, 100 mg

* Underlined part shows the revised one according to this approval

Ono Pharma Taiwan Co., Ltd. (OPTW), in Taipei, Taiwan, was established as an ONO's wholly-owned subsidiary in December 2014. OPTW has started to market specialty products such as anti-cancer agents, including Opdivo. OPTW is committed to distributing and bringing its products developed internally for further penetration into the Taiwanese market.

Opdivo is an immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands.

In Japan, ONO launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell cancer in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, and unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017. In addition, ONO is conducting clinical development program including esophageal cancer, esophago-gastric junction cancer, small cell lung cancer, hepatocellular carcinoma, glioblastoma, urothelial cancer, malignant pleural mesothelioma, ovarian cancer, biliary tract cancer, etc. Opdivo is currently approved in more than 60 countries including Japan, South Korea, Taiwan, the US and European Union.

In 2011, through a collaboration agreement with Bristol-Myers Squibb (BMS), Ono Pharmaceutical Co., Ltd. (ONO) granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where ONO had retained all rights to Opdivo except the US at the time. In July 2014, ONO and BMS further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agent and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.

Contact

ONO PHARMACEUTICAL CO., LTD.

Corporate Communications public_relations@ono.co.jp