Table of Contents
Table of Contents 3
List of Tables 7
List of Figures 7
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Year, 2012 to YTD 2018 9
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare Deals By Type, 2012 to YTD 2018 10
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Region, 2012 to YTD 2018 11
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Therapy Area, 2012 to YTD 2018 12
Ono Pharmaceutical Co Ltd, Medical Devices Deals, 2012 to YTD 2018 14
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals Summary, 2012 to YTD 2018 15
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deal Details 18
Partnerships 18
Fate Therapeutics Enters into Agreement with ONO Pharma 18
Ono Pharma Enters into Research Agreement with Schrodinger 19
Cyclenium Pharma Enters into Agreement with Ono Pharma 20
Neurimmune Therapeutics Enters into Co-Development Agreement with Ono Pharma 21
Ono Pharma Enters into Agreement with Eisai 22
Ono Pharma and Seikagaku Enter into Co-Development Agreement 23
Numab Therapeutics Enters into Research and Option Agreement with Ono Pharma 24
X-Chem Enters into Agreement with Ono Pharma 25
Takeda Pharma and Shionogi Enter into Research Agreement with Sumitomo Dainippon Pharma, Ono Pharma and Mitsubishi Tanabe Pharma 26
Astellas Pharm, Kyowa Hakko Kirin, Daiichi Sankyo, Eisai, Ono Pharma and Chugai Pharma to Enter into Agreemet with Four Research Institutions 28
Ono Pharma Enters into Development Agreement with China Chemical & Pharma for Limaprost Alfadex 30
Dako Enters into Development Agreement with ONO PHARMA for Opdivo 31
Ono Pharma Enters into Development Agreement with Meiji Seika for Limaprost Alfadex 32
Bristol-Myers Squibb Enters into Co-Development Agreement with Ono Pharma 33
AstraZeneca Enters Into Co-Promotion Agreement With Ono Pharma For Dapagliflozin 35
Ono Pharma Expands Co -Development Agreement With Dainippon Sumitomo Pharma For Limaprost Alfadex 36
Ono Pharma Enters Into Drug Discovery Agreement With Domain Therapeutics 37
Ono Pharma Enters Into Discovery Agreement With BioFocus For CNS Drugs 38
Ono Pharma Enters Into Drug Discovery Agreement With BioFocus 39
Ono Pharma Enters Into Co-Development Agreement With Scil Proteins For Affilin Therapeutics 40
Licensing Agreements 41
Ono Pharma Enters into Licensing Agreement with Merus 41
Bristol-Myers Squibb Enters into Licensing Agreement with Ono Pharma for ONO-4578 42
ONO Pharma Enters into Licensing Agreement with Karyopharm Therapeutics 43
Ono Pharma Enters into Licensing Agreement with Array BioPharma 44
Merck Enters into Licensing Agreement with Bristol-Myers Squibb and Ono Pharma 45
Ono Pharma Enters into Licensing Agreement with Ligand Pharma 47
ONO Pharma Enters into Licensing Agreement with Celyad 48
ONO Pharma Enters into Licensing Agreement with IDAC Theranostics 49
Santen Pharma Enters into Licensing Agreement with Ono Pharma 50
Ono Pharma Enters into Licensing Agreement with Gilead Sciences for ONO-4059 51
Ono Pharma Exercises Option for Licensing Agreement with with Merus 52
Ono Pharma Enters into Licensing Agreement with Valeant Pharma 53
Ono Pharma Enters Into Licensing Agreement With Bial For BIA 9-1067 54
Ono Pharma Enters Into Licensing Agreement With Genedata For Genedata Expressionist 55
Asset Transactions 56
Maruishi Pharma to Acquire Five Injectable Brands from Ono Pharma 56
Ono Pharmaceutical Co Ltd – Key Competitors 57
Ono Pharmaceutical Co Ltd – Key Employees 58
Ono Pharmaceutical Co Ltd – Locations And Subsidiaries 59
Head Office 59
Other Locations & Subsidiaries 59
Recent Developments 61
Strategy And Business Planning 61
Mar 01, 2018: Ono Pharmaceutical Announce Completion of a New Tokyo Building 61
Corporate Communications 62
Jul 13, 2018: Ono Pharmaceutical: Support for the Torrential rain damage in Western Japan 62
Apr 05, 2018: Ono Pharmaceutical Announce on Candidates of Members of the Board of Directors and Corporate Officers 63
Government and Public Interest 64
May 30, 2018: Notice Regarding Establishment of Immune-mediated Inflammatory Diseases Consortium for Drug Development 64
Product News 65
11/30/2017: Cancer drug leads to drastic decrease in HIV infection in lung cancer patient 65
11/15/2017: LabCorp Announces New Expanded Use for PD-L1 Test with Bristol-Myers Squibb’s OPDIVO 67
11/10/2017: Encouraging Response Observed with Opdivo (nivolumab) Plus Investigational IDO1 Inhibitor, BMS-986205, in Heavily Pre-Treated Patients with Advanced Cancers in Phase 1/2a Study CA017-003 68
11/07/2017: Opdivo (Nivolumab) Intravenous Infusion Approved in Taiwan for Expanded Use in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with Platinum-based Therapy 70
10/30/2017: 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 71
09/22/2017: Bristol-Myers Squibb’s Opdivo Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib 72
09/22/2017: Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Gastric Cancer Which Has Progressed After Chemotherapy 74
09/21/2017: Promising immunotherapy drug now available for some lung cancer patients in England 76
09/20/2017: Opdivo (Nivolumab) Intravenous Infusion Approved for Expanded Use in Advanced Non-squamous Non-small Cell Lung Cancer which Has Been Previously Treated with Platinum-based Therapy in Taiwan 77
09/20/2017: Nivolumab now available for lung cancer after company offers NICE new CDF deal 78
09/19/2017: Opdivo (Nivolumab) Intravenous Infusion Approved for Expanded Use in Unresectable or Metastatic Melanoma in South Korea 79
08/30/2017: Opdivo (Nivolumab) Intravenous Infusion Approved for Supplemental Indications of Advanced Renal Cell Carcinoma, Relapsed or Progressed Classical Hodgkin Lymphoma, Recurrent or Metastatic Head and Neck, Locally Advanced or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma in Combination with Ipilimumab in South Korea 80
08/16/2017: Opdivo Intravenous Infusion Approved for Supplemental Indication of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck with Disease Progression on or after Platinum-based Therapy in Taiwan 81
08/11/2017: FDA Approves Updated Indication for Opdivo (nivolumab) 82
08/01/2017: Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan 83
06/02/2017: NICE approves first use of Opdivo (nivolumab) in blood cancer 84
05/17/2017: Health Canada approves OPDIVO (nivolumab) for the treatment of squamous cell carcinoma of the head and neck 85
05/05/2017: White Blood Cell Count Predicts Response to Lung Cancer Immunotherapy 86
04/28/2017: European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy 87
04/24/2017: Opdivo (nivolumab) Designated for the Treatment of Biliary Tract Cancer Under the SAKIGAKE Designation System 89
04/21/2017: CHMP Adopts Extension To Existing Therapeutic Indication For Opdivo 90
04/21/2017: Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer 91
04/03/2017: Patients with Lung Cancers Responsive to Immunotherapy Drug Beat Standard Odds of Survival 92
03/24/2017: Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) for the Treatment of Squamous Cell Cancer of the Head and Neck in Adults Progressing on or After Platinum-based Therapy 94
03/24/2017: ONO Receives Approval for OPDIVO (Nivolumab) Intravenous Infusion for Treatment of Recurrent or Metastatic Head and Neck Cancer as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan 95
03/22/2017: Ontario Latest Province to Cover Cost of Immuno-Oncology Treatment OPDIVO (nivolumab) 96
03/15/2017: Manitoba to Cover Immuno-Oncology Treatment OPDIVO (nivolumab) for Three Tumour Types 97
03/02/2017: British Columbia to Cover Immuno-Oncology Treatment OPDIVO (nivolumab) for Three Tumour Types 98
02/02/2017: Bristol-Myers Squibb Company Received Approval for Nivolumab by U.S. Food and Drug Administration for Treatment of Urothelial Carcinoma 99
Product Approvals 100
Jul 30, 2018: ONO submits supplemental application of ONOACT for intravenous infusion 50mg·150mg, short-acting selective ß1 blocker for indication of ventricular arrhythmia for a partial change in approved items of manufacturing and marketing approval in Japan 100
Oct 30, 2017: European Medicines Agency Validates Bristol-Myers Squibbs Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma 101
Oct 16, 2017: U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review 102
Sep 21, 2017: Withdrawal of the Application for a Change to the Marketing Authorisation for Nivolumab in EU 103
Sep 15, 2017: Withdrawal of the application for a change to the marketing authorisation for Opdivo (nivolumab) 104
Sep 11, 2017: Opdivo is accepted for restricted use within NHS Scotland 105
Jul 24, 2017: U.S. Food and Drug Administration Accepts Bristol-Myers Squibbs Applications for Opdivo (nivolumab) Four-Week Dosing Schedule Across All Approved Indications 106
Jul 10, 2017: SMC says ‘yes’ to Opdivo (nivolumab) for blood cancer patients 107
Jun 12, 2017: SMC ‘U-turn’ brings breakthrough immunotherapy Opdivo (nivolumab) to kidney cancer patients 108
Jun 02, 2017: European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Previously Treated Locally Advanced Unresectable or Metastatic Urothelial Carcinoma in Adults After Failure of Prior Platinum-Containing Therapy 109
May 24, 2017: U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma 111
Apr 04, 2017: U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer 112
Clinical Trials 113
Dec 05, 2017: U.S. Food and Drug Administration Lifts Partial Clinical Holds on Two Opdivo-based Combination Studies in Multiple Myeloma 113
Nov 30, 2017: CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival 114
Nov 29, 2017: Bristol-Myers Squibb to Present Clinical Trial Data of Antineoplastic Agent Nivolumab at the 59th Annual Meeting & Exposition of the American Society of Hematology 115
Nov 06, 2017: Opdivo (nivolumab) Demonstrates Superior Three-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma 117
Oct 25, 2017: New Investigator Led Study Examining the Combination of SIR-Spheres Y-90 Resin Microspheres with Opdivo in HCC 118
Oct 13, 2017: NICE U-turn recommends head and neck cancer medicine which offers biggest increase in survival for 20 years 119
Oct 12, 2017: Stand Up To Cancer Awards Moffitt $2.67 Million to Study New Lung Cancer Immunotherapy 120
Sep 27, 2017: Bristol-Myers Squibb: Advancing Research Across Thoracic Cancers with New Data at IASLC 18th World Conference on Lung Cancer 121
Sep 10, 2017: Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study 124
Sep 08, 2017: Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer 126
Sep 06, 2017: Bristol-Myers Squibb Provides an Update on Three Opdivo-based Combination Clinical Studies in Multiple Myeloma 128
Aug 30, 2017: Bristol-Myers Squibb Data at ESMO 2017 Demonstrate Company’s Innovative Research Approach to Treating Cancer from All Angles 129
Jul 10, 2017: Exelixis and Bristol-Myers Squibb Initiate Phase 3 Trial of Opdivo in Combination with CABOMETYX or Opdivo and Yervoy in Combination with CABOMETYX, Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma 135
Jul 05, 2017: Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint 136
Jun 21, 2017: First-line immunotherapy treatment can improve survival for subset of lung cancer patients 137
Jun 16, 2017: Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma 138
Jun 05, 2017: Encouraging Disease Control Rates Observed with Nivolumab Alone or in Combination with Ipilimumab in Refractory or Relapsing Malignant Pleural Mesothelioma Patients: Results from IFCT-1501 MAPS-2 Trial 139
Jun 02, 2017: Opdivo (nivolumab) Data in Patients with Advanced Cervical, Vaginal and Vulvar Cancers from Phase 1/2 CheckMate -358 Presented at ASCO 140
May 18, 2017: New trial to fight cancer caused by asbestos 142
Apr 11, 2017: Head and neck cancer patients set to miss out on first medicine to show biggest increase in survival for 20 years 144
Apr 04, 2017: Unprecedented 5-year follow-up shows long-term survival in lung cancer 145
Apr 03, 2017: Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme 147
Apr 03, 2017: Five-Year Survival Observed With Opdivo (nivolumab) in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer, in Phase 1 Study CA209-003 148
Apr 03, 2017: Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma 150
Apr 02, 2017: Bristol-Myers Squibb and Incyte to Advance the Combination of Opdivo (nivolumab) and Epacadostat into First-line Registrational Trials 152
Jan 19, 2017: Opdivo (nivolumab) Demonstrated Efficacy and Improved Survival in Patients with Previously Treated Advanced Gastric Cancer in a Randomized Phase 3 Study 153
Appendix 155
Methodology 155
About GlobalData 155
Contact Us 155
Disclaimer 155
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Key Facts, 2018 2
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Year, 2012 to YTD 2018 9
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare Deals By Type, 2012 to YTD 2018 10
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Region, 2012 to YTD 2018 11
Ono Pharmaceutical Co Ltd, Deals By Therapy Area, 2012 to YTD 2018 12
Ono Pharmaceutical Co Ltd, Medical Devices Deals, 2012 to YTD 2018 14
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals Summary, 2012 to YTD 2018 15
Fate Therapeutics Enters into Agreement with ONO Pharma 18
Ono Pharma Enters into Research Agreement with Schrodinger 19
Cyclenium Pharma Enters into Agreement with Ono Pharma 20
Neurimmune Therapeutics Enters into Co-Development Agreement with Ono Pharma 21
Ono Pharma Enters into Agreement with Eisai 22
Ono Pharma and Seikagaku Enter into Co-Development Agreement 23
Numab Therapeutics Enters into Research and Option Agreement with Ono Pharma 24
X-Chem Enters into Agreement with Ono Pharma 25
Takeda Pharma and Shionogi Enter into Research Agreement with Sumitomo Dainippon Pharma, Ono Pharma and Mitsubishi Tanabe Pharma 26
Astellas Pharm, Kyowa Hakko Kirin, Daiichi Sankyo, Eisai, Ono Pharma and Chugai Pharma to Enter into Agreemet with Four Research Institutions 28
Ono Pharma Enters into Development Agreement with China Chemical & Pharma for Limaprost Alfadex 30
Dako Enters into Development Agreement with ONO PHARMA for Opdivo 31
Ono Pharma Enters into Development Agreement with Meiji Seika for Limaprost Alfadex 32
Bristol-Myers Squibb Enters into Co-Development Agreement with Ono Pharma 33
AstraZeneca Enters Into Co-Promotion Agreement With Ono Pharma For Dapagliflozin 35
Ono Pharma Expands Co -Development Agreement With Dainippon Sumitomo Pharma For Limaprost Alfadex 36
Ono Pharma Enters Into Drug Discovery Agreement With Domain Therapeutics 37
Ono Pharma Enters Into Discovery Agreement With BioFocus For CNS Drugs 38
Ono Pharma Enters Into Drug Discovery Agreement With BioFocus 39
Ono Pharma Enters Into Co-Development Agreement With Scil Proteins For Affilin Therapeutics 40
Ono Pharma Enters into Licensing Agreement with Merus 41
Bristol-Myers Squibb Enters into Licensing Agreement with Ono Pharma for ONO-4578 42
ONO Pharma Enters into Licensing Agreement with Karyopharm Therapeutics 43
Ono Pharma Enters into Licensing Agreement with Array BioPharma 44
Merck Enters into Licensing Agreement with Bristol-Myers Squibb and Ono Pharma 45
Ono Pharma Enters into Licensing Agreement with Ligand Pharma 47
ONO Pharma Enters into Licensing Agreement with Celyad 48
ONO Pharma Enters into Licensing Agreement with IDAC Theranostics 49
Santen Pharma Enters into Licensing Agreement with Ono Pharma 50
Ono Pharma Enters into Licensing Agreement with Gilead Sciences for ONO-4059 51
Ono Pharma Exercises Option for Licensing Agreement with with Merus 52
Ono Pharma Enters into Licensing Agreement with Valeant Pharma 53
Ono Pharma Enters Into Licensing Agreement With Bial For BIA 9-1067 54
Ono Pharma Enters Into Licensing Agreement With Genedata For Genedata Expressionist 55
Maruishi Pharma to Acquire Five Injectable Brands from Ono Pharma 56
Ono Pharmaceutical Co Ltd, Key Competitors 57
Ono Pharmaceutical Co Ltd, Key Employees 58
Ono Pharmaceutical Co Ltd, Other Locations 59
Ono Pharmaceutical Co Ltd, Subsidiaries 60
List of Figures
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals by Type, 2012 to YTD 2018 2
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Year, 2012 to YTD 2018 2
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Region, 2012 to YTD 2018 2
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Therapy Area, 2012 to YTD 2018 2
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Year, 2012 to YTD 2018 9
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals by Type, 2012 to YTD 2018 10
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Region, 2012 to YTD 2018 11
Ono Pharmaceutical Co Ltd, Pharmaceuticals & Healthcare, Deals By Therapy Area, 2012 to YTD 2018 12
Ono Pharmaceutical Co Ltd, Medical Devices Deals, 2012 to YTD 2018 14
