Global Development Projects

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2 Global Development Projects 1/9 Development code ONO-4641 Target Disease Overseas* Japan* Renal cell carcinoma, Melanoma, Non-small cell lung cancer etc Multiple sclerosis III (BMS) 海外 ( 欧米 ) で 2 化合物以上の上市 ( 導出 ) 現在のグローバル開発品状況一覧表 III III under preparation (with Merck KGaA) ONO-6950 Bronchial asthma II I ONO-4053 Allergic rhinitis II - ONO-2952 Irritable bowel syndrome (IBS) II - ONO-9054 Glaucoma, ocular hypertension I - ONO-7746 Thrombocytopenia I - ONO-4059 B-cell lymphoma I - ONO-8055 Underactive bladder I - ONO-8539 Gastroesophageal reflux disease I *the most advanced stage is shown ONO-2160 Parkinson s disease - I

3 Product name/product candidate name/development code Planned indication Japan ONO-4164SC (Orencia SC) Development pipeline list (Japan) 2/9 Rheumatoid arthritis 国内で 10 品以上の上市 現在の国内開発品状況一覧表 P a s s e d E v a l u a t i o n C o m m i t t e e Glactiv 12.5mg Tablets (additional formulation) Type II diabetes with severe renal dysfunction F i l i n g Onoact (additional indication) Tachyarrhythmia in low cardiac function F i l i n g Glactiv (additional indication) Type 2 diabetes (combination therapy with rapid-acting SU) III Glactiv (FDC with Metformin) Type 2 diabetes III Proemend (pediatric) Chemotherapy-induced nausea and vomiting III Rivastach Patch (Additional dosing regimen) Alzheimer s disease III Renal cell carcinoma III ONO-2745 General anetsthesia II / III ONO-7165 (Stimuvax) Non-small cell lung cancer II ONO-4641 Multiple sclerosis (International study including Japan) II ONO-3849 Opioid-induced constipation II ONO-7643 Cancer cachexia II Melanoma II Non-small cell lung cancer II ONO-2745 ICU sedation II ONO-5163 Secondary hyperparathyroidism I / II ONO-7057 Multiple myeloma I / II ONO-6950 Bronchial asthma I ONO-7056 Pancreatic cancer I ONO-7628 MX1 Hepatic cell carcinoma I ONO-1162 Chronic heart failure I ONO-2160 Parkinson s disease I

4 Product Name/Development code Target disease Overseas Japan ONO-7057 (Carfilzomib) ONO-3849 Cancer/Cancer-related projects 3/9 Multiple myeloma Opioid-induced constipation Launched in US (Onyx) Launched (Progenics) Renal cell carcinoma III (JP/US/EU, with BMS) Melanoma III (BMS ) II Non-small cell lung cancer III (BMS ) II ONO-7165 (Stimuvax) Non-small cell lung cancer III (Merck KGaA) II ONO-7643 Cancer cachexia III (Helsinn) II Proemend (pediatrics) Chemotherapy-induced nausea and vomiting II (Merck) III I/II II Hematologic malignancies B cell lymphoma, T cell lymphoma, Multiple myeloma, Hodgkin lymphoma, Chronic leukemia I (BMS) hepatocellular carcinoma I (BMS) ONO-7746 Chemotherapy-induced thrombocytopenia I - ONO-7056 (Salirasib) Pancreatic cancer etc I (Kadmon) I ONO-7268MX1 Hepatic cell carcinoma etc - I ONO-7058 (ONX0912) Cancer I (Onyx) - ONO-4059 B cell lymphoma I -

5 Development status of (nivolumab) 4/9 Development code Target disease Overseas Japan Renal cell carcinoma III (JP/US/EU, with BMS) Melanoma III (BMS) II Non-small cell lung cancer III (BMS) II hematologic malignancies B cell lymphoma, T cell lymphoma, Multiple myeloma, Hodgkin lymphoma, Chronic leukemia I (BMS) hepatocellular carcinoma I (BMS) Melanoma ( combination with Ipilimumab ) Non-small cell lung cancer ( combination with chemotherapy ) Renal cell carcinoma ( combination with sunitinib, pazopanib, or ipilimumab ) I (BMS) I (BMS) I (BMS) I

6 Outline : Drug Therapy Flow Chart for Non-Small Cell Lung Cancer Patients naïve to chemotherapy Approx % Approx % Non-Squamous cell cancer Squamous cell cancer Approx % Approx % EGFR gene mutation positive EGFR gene mutation negative/unknown 5/9 1 st line EGFR-TKI Combination with platinum-doublet 2 nd line 3 rd line Combination with platinum-doublet EGFR-TKI Decetaxel, gemcitabine, pemetrexed etc Decetaxel, gemcitabine, pemetrexed etc : Population aimed to obtain the indication for (monotherapy) this time : Population aimed to obtain the indication for (combination or monotherapy) in the future EGFR : Epidermal Growth Factor Receptor, TKI: Tyrosine Kinase Inhibitor * ALK inhibitors are recommended for ALK-rearranged non-small cell lung cancer

7 Treatment Flow for Renal Cell Carcinoma in Japan 6/9 Advanced or metastatic renal cell carcinoma ( low or middle risk) Lung metastasis only Tyrosine kinase inhibitor (snitinib, sorafenib) IFN-α Tyrosine kinase inhibitor (snitinib, sorafenib) mtor inhibitor (everolimus) Clinical study etc : Population aimed to obtain the indication for (monotherapy) this time : Population aimed to obtain the indication for (combination or monotherapy) in the future * axitinib is not reflected in Japanese guideline 2011 yet.

8 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Interim Analysis in Clinical Trials ) 7/9 Non-small cell lung cancer (NSCLC) Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS ; ) in patients (pts) with previously treated advanced nonsmall cell lung cancer (NSCLC). A phase I study of nivolumab (anti-pd-1; BMS , ) plus platinumbased doublet chemotherapy (PTdoublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts). Renal cell carcinoma (mrcc) Survival, safety, and response duration results of nivolumab (Anti-PD-1; BMS ; ) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mrcc): Long-term patient follow-up. Melanoma Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab (anti-pd-1; BMS ; ). Safety and clinical activity of nivolumab (anti-pd-1, BMS , ) in combination with ipilimumab in patients (pts) with advanced melanoma (MEL). Peripheral and tumor immune correlates in patients with advanced melanoma treated with combination nivolumab (anti-pd-1, BMS , ) and ipilimumab. Phase I/II trial of PD-1 antibody nivolumab with peptide vaccine in patients naive to or that failed ipilimumab. Safety and efficacy of adjuvant anti-pd1 therapy (nivolumab) in combination with vaccine in resected high-risk metastatic melanoma. Other Association of tumor PD-L1 expression and immune biomarkers with clinical activity in patients (pts) with advanced solid tumors treated with nivolumab (anti-pd-1; BMS ; ). Nivolumab (anti-pd-1; BMS ; ) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.

9 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Study design 1 ) 8/9 Non-small cell lung cancer (NSCLC) A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC). A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus docetaxel in patients with previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). Renal cell carcinoma (mrcc) A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus everolimus in patients (pts) with advanced or metastatic renal cell carcinoma (mrcc) previously treated with antiangiogenic therapy. A phase I study of nivolumab (anti-pd-1; BMS ; ) in combination with sunitinib, pazopanib, or ipilimumab in patients (pts) with metastatic renal cell carcinoma (mrcc). Melanoma A phase III open-label study of nivolumab (anti-pd-1; BMS ; ) versus investigator s choice in advanced melanoma patients progressing post anti-ctla-4 therapy. A phase III, randomized, double-blind study of nivolumab (anti-pd-1; BMS ; ) versus dacarbazine in patients (pts) with previously untreated, unresectable, or metastatic melanoma (MEL). An open-label, randomized, phase II study of nivolumab (anti-pd-1; BMS ; ) given sequentially with ipilimumab in patients (pts) with advanced or metastatic melanoma (MEL). An exploratory study of the biologic effects of nivolumab (Anti-PD-1; BMS ; ) treatment in patients (pts) with advanced (unresectable or metastatic) melanoma (MEL).

10 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Study design 2 ) 9/9 Other A phase I dose-escalation study evaluating the effects of nivolumab (anti-pd-1; BMS ; ) in patients (pts) with select relapsed or refractory hematologic malignancies. Phase I dose escalation study of recombinant interleukin-21 (ril-21; BMS ) in combination with nivolumab (anti- PD-1; BMS ; ) in patients (pts) with advanced or metastatic solid tumors. A phase I dose-escalation and cohort expansion study of lirilumab (anti-kir; BMS ) administered in combination with nivolumab (anti-pd-1; BMS ; ) in patients (Pts) with advanced refractory solid tumors. Phase I dose escalation study of nivolumab (Anti-PD-1; BMS ; ) in patients (pts) with advanced hepatocellular carcinoma (HCC) with or without chronic viral hepatitis.

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