Company News & News Release

Dec.19.2014……ONO AND GILEAD ANNOUNCE EXCLUSIVE LICENSE AGREEMENT TO DEVELOP BTK INHIBITOR, ONO-4059, FOR THE TREATMENT OF B-CELL MALIGNANCIES AND OTHER DISEASES

Dec.11.2014……ONO Establishes a Local Subsidiary in Taiwan

Dec.10.2014……ONO PHARMACEUTICAL, Bristol-Myers Squibb and Kyowa Hakko Kirin Announce Immuno-Oncology Clinical Collaboration Studying Opdivo (nivolumab) and Mogamulizumab in Advanced Solid Tumors

Dec.10.2014……Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma

Nov.19.2014……Study Comparing Opdivo (nivolumab) to Chemotherapy in Treatment Naive Advanced Melanoma Patients Marks First PD-1 Immune Checkpoint Inhibitor to Demonstrate a Survival Benefit in a Phase 3 Trial

Nov.05.2014……ONO files an application for RIVASTACH® PATCH for adding dosage and administration in Japan

Nov.05.2014……Announcement on Financial Results for FY2014 2Q

Oct.31.2014……Phase 2 Objective Response Rates and Survival Data for Opdivo (nivolumab) in Heavily Pre-treated Advanced Squamous Cell Non-Small Cell Lung Cancer to be Presented at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology

Oct.31.2014……Helsinn Group, Switzerland, announced new data on Fatigue from Phase III Trial (ROMANA 1) of Anamorelin/ONO-7643 in patients with Cancer Anorexia-Cachexia Syndrome (CACS) associated with Non-Small Cell Lung Cancer at 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology

Oct.29.2014……Establishment of GPCR Consortium, a New International Partnership, to Advance Structural Information about G-protein Coupled Receptors

Oct.08.2014……Revisions of Consolidated Financial Forecasts

Oct.07.2014……Approval for the Stability-Improved Formulation of Limaprost, an Oral Prostaglandin E1 Analogue in Japan

Oct.03.2014……European Medicines Agency Validates the Marketing Authorization Application for Opdivo (Nivolumab) in Non-Small Cell Lung Cancer

Oct.02.2014……Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab) in the U.S. and European Union

Sep.30.2014……Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy® (ipilimumab) Presented at the ESMO 2014 Congress

Sep.29.2014……Helsinn Group, Switzerland, announced the results of Phase III Trials (ROMANA 1 and ROMANA 2) of Anamorelin/ONO-7643 in patients with Cancer Anorexia-Cachexia Syndrome (CACS) associated with Non-Small Cell Lung Cancer

Sep.02.2014……Human Anti-human PD-1 Monoclonal Antibody OPDIVO® Intravenous Infusion 20 mg/100 mg launches in Japan for Treatment of Unresectable Melanoma

Aug.20.2014……Announcement of top-line results from Phase 3 FOCUS Trial of Carfilzomib (ONO-7057), a proteasome inhibitor, in patients with relapsed and advanced refractory multiple myeloma

Aug.11.2014……Phase 3 ASPIRE Trial of Carfilzomib (ONO-7057), a proteasome inhibitor, in patients with relapsed multiple myeloma met primary endpoint (Progression-free survival)

Aug.04.2014……Announcement on Financial Results for FY2014 1Q

July.28.2014……Ono and Meiji Seika Pharma enter into an agreement on development and ommercialization of Limaprost in Thailand and Indonesia

July.24.2014……ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan

July.11.2014……Human Anti-human PD-1 Monoclonal Antibody OPDIVO® Bristol-Myers Squibb plans for Third Quarter Submission of a Biologics License Application for Previously Treated Advanced Melanoma

July.09.2014……Ono Enters into the Collaboration Agreement with the University of Tokyo regarding Access to Ono's Compound Library

July.04.2014……Human Anti-human PD-1 Monoclonal Antibody "OPDIVO® Intravenous Infusion 20 mg/100 mg" Receives Manufacturing and Marketing Approval in Japan for the Treatment of Unresectable Melanoma

Jun.27.2014……Notice to Resolutions Passed at the 66th Ordinary General Shareholders' Meeting

Jun.25.2014……2014Fully Human Anti-PD-1 Antibody Nivolumab ("ONO-4538/BMS-936558") Demonstrates Superior Overall Survival Compared to Dacarbazine in Phase 3 First-Line Melanoma Study (CheckMate -066)

Jun.17.2014……Termination of the license agreement for ONO-4641 mutually agreed by Ono and Merck

Jun.05.2014……Notice to Convene the 66th Ordinary General Shareholders' Meeting

Jun.03.2014……Fully Human Anti-PD-1 Antibody “ONO-4538/BMS-936558”Results from Phase 1 Study in Patients with Melanoma Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO)

May.23.2014……Glactiv® has obtained the approval of the partial change in the indications of "type 2 diabetes"

May.23.2014……FORXIGAR® launches in Japan for the treatment of Type 2 diabetes

May.13.2014……Position and policies concerning the reduction of the minimum investment unit

May.13.2014……Announcement on Candidates of Members of the Board of Directors and Corporate Officers

May.13.2014……Announcement on Financial Results for FY2013

Apr.30.2014……Discontinuation of the license agreement for a new therapeutic agent for thrombocytopenia

Mar.24.2014……FORXIGA® (dapagliflozin) receives regulatory approval in Japan for the treatment of Type 2 diabetes

Mar.06.2014……ONO establishes an innovative research network called "Orientem Innovation" together with Tohoku University & The University of Tokyo

Feb.04.2014……Announcement on Financial Results for FY2013 3Q

Jan.17.2014……Annoucement on CSR Report 2013

Dec.24.2013……ONO Files for Regulatory Approval of "Nivolumab (ONO-4538/BMS-936558)" for Treatment of Malignant Melanoma

Dec.16.2013……FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for the Treatment of Type 2 Diabetes in Adults

Dec.13.2013……Ono Establishes a Local Subsidiary in South Korea

Dec.09.2013……Clinical Trial Application submitted for Phase I study of ONO-7268MX2, peptide-cocktail vaccine for hepatocellular carcinoma

Dec.03.2013……AstraZeneca and Ono Enter Co-promotion Agreement in Japan for Dapagliflozin

Nov.22.2013……Approval for Additional Indication of Onoact® 50 for injection, Short-Acting Selective β1 Blocker in Japan

Nov.14.2013……Results of Phase II/III Study of ONO-2745/CNS 7056, a Short-acting General Anesthetic

Nov.05.2013……Announcement on Financial Results for FY2013 2Q

Oct.28.2013……Fully Human Anti-PD-1 Antibody "Nivolumab (ONO-4538/BMS-936558)" Updated Results from a Phase 1 Study in Patients with NSCLC Presented at 15th World Conference on Lung Cancer

Oct.22.2013……Ono Enters into License Agreement with Valeant

Oct.09.2013……Ono Establishes a Local Subsidiary in South Korea

Oct.01.2013……Fully Human Anti-PD-1 Antibody "Nivolumab (ONO-4538/BMS-936558)" Result from Phase II Study in Patients with Melanoma Presented at European Cancer Congress 2013

Sep.27.2013……Decision to Continue the Development of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer to be Announced

Sep.03.2013……Announcement on Annual Report 2013

Aug.27.2013……Rheumatoid Arthritis Drug ORENCIA® SC 125mg Syringe 1mL Launched in Japan

Aug.13.2013……Ono Pharmaceutical and MSD applied for partial change in indications of "Sitagliptin", to add "type 2 diabetes"

Aug.06.2013……Application Submission for Approval for the Stability-Improved Formulation of Limaprost,an Oral Prostaglandin E1 Analogue in Japan

Aug.02.2013……Announcement on Financial Results for FY2013 1Q

Aug.02.2013……"Glactiv® tablets"for the oral treatment of type 2 diabetes Contraindication was removed and replaced by careful administration in patients with severe renal insufficiency

July.05.2013……Subcutaneous (SC) formulation of ORENCIA® (abatacept) Results of Year Two Data from AMPLE Study in Patients with Moderate to Severe Rheumatoid Arthritis Presented at the European League Against Rheumatism (EULAR) Annual Congress

Jun.28.2013……Rheumatoid Arthritis Drug ORENCIA® SC 125mg Syringe 1mL Approved for Production and Distribution

Jun.26.2013……Notice of Resolutions Passed at the 65th Ordinary General Shareholders' Meeting

Jun.04.2013……Notice to Convene the 65th Ordinary General Shareholders' Meeting

Jun.04.2013……Bristol-Myers and Ono Pharmaceutical to Announce Lifting of Approval Conditions (Completion of PMS: "All-Case Surveillance") and Start of Co-Promotion

Jun.03.2013……Fully Human Anti-PD-1 Antibody "ONO-4538/BMS-936558" Results from Phase 1 Study in Patients with Melanoma Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO)

May.16.2013……Detailed Results of Phase III Trial of L-BLP25 in Patients with Non-Small Cell Lung Cancer (START) to be Presented at ASCO

May.13.2013……Voluntary adoption of International Financial Reporting Standards (IFRS)

May.13.2013……Partial Amendment of Articles of Incorporation

May.13.2013……Announcement on Financial Results for FY2012

May.09.2013……Announcement on Candidates of Members of the Board of Directors,Corporate Auditors and Corporate Officers

May.08.2013……Ono and Dainippon Sumitomo reach agreement on expanding business relating to Limaprost into China

Apr.18.2013……Ono Enters into License Agreement with Bial

Feb.20.2013……Additional Indication Application filed for Onoact® 50 for injection,Short-Acting Selective β1 Blocker in Japan

Feb.04.2013……Announcement on Financial Results for FY2012 3Q

Jan.25.2013……Discontinuation of Development for the Additional Indication of Carpal-Tunnel Syndrome, for Limaprost, an Oral Prostaglandin E1 Analogue

Dec.19.2012……Phase III Trial of L-BLP25 (Stimuvax®) in Patients with Non-Small Cell Lung Cancer Did not Meet Primary Endpoint

Nov.05.2012……Announcement on Financial Results for FY2012 2Q

Oct.23.2012……Ono Enters into Collaboration Agreement with Domain Therapeutics in the Field of GPCR-Based Drug Discovery

Oct.04.2012……Ono Conducts the Nation's First Microdosing Study Using Its Novel and Innovative Drug Candidate

Sep.28.2012……Announcement on Annual Report 2012

Sep.03.2012……Ono and Galapagos Subsidiary BioFocus Sign Drug Discovery Agreement in the Field of CNS Disorders

Aug.02.2012……Announcement on Financial Results for FY2012 1Q

Jul.23.2012……Carfilzomib, a proteasome inhibitor, has been granted FDA accelerated approval

Jul.10.2012……Bristol-Myers K.K. Files for Regulatory Approval in Japan for ORENCIA® Subcutaneous Injection (abatacept [rDNA]), Rheumatoid Arthritis Agent

Jul.02.2012……Clinical Trial Application submitted for Phase I study of ONO-7268MX1, peptide-cocktail vaccine for hepatocellular carcinoma

Jun.22.2012……Approval for Additional Indication of "EMEND® Capsule", an Antiemetic Selective Neurokinin-1 (NK1) Receptor Antagonist, for Pediatric Patients Aged 12 and older

Jun.21.2012……Voting result on Carfilzomib at FDA Oncologic Drug Advisory Committee

Jun.08.2012……Announcement on Appointment of Corporate Officer

Jun.04.2012……Fully Human Anti-PD-1 Antibody "ONO-4538/BMS-936558" Results from Phase 1 Study in Cancer Patients Published in New England Journal of Medicine (NEJM) and Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO)

May.30.2012……Ono and Galapagos Subsidiary BioFocus Sign an Additional Target Discovery Agreement in the Field of Allergic Disease

May.15.2012……Ono Enters into Drug Discovery Collaboraition with Scil Proteins for Affilin® Therapeutics

May.14.2012……Results of PhaseUStudy of ONO-2745/CNS 7056, a Short-acting General Anesthetic

May.9.2012……Announcement on Financial Results for FY2011

Apr.23.2012……Revisions of Consoldated Financial Forecasts

Apr.17.2012……ONO-4641 Met Primary Endpoint of Phase II Study in Multiple Sclerosis Patients

Dec.22.2011……Leukotriene Receptor Antagonist "Onon® Dry Syrup 10%" has received approval for the additional indication of allergic rhinitis

Dec.13.2011……Ono Enters into Drug Discovery Collaboration with Receptos on GPCR Protein Crystal Structure Determination Technology

Dec.08.2011……Launch of an Intravenous Antiemetic Selective Neurokinin-1(NK1)Receptor Antagonist,"PROEMEND® Intravenous infusion 150mg"

Nov.30.2011……FDA Acceptance of New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma in the U.S.

Nov.14.2011……Announcement of the results from a Phase 2 study of "ONO-5163/KAI-4169":a calcium sensing receptor agonist

Oct.20.2011……Revisions of Consolidated Financial Forecasts

Oct.04.2011……Ono to Enter into License Agreements with Merck KGaA

Sep.29.2011……Additional Indication Application Filed for a Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting"EMEND® Capsule"for Pediatric Patients Aged 12 and older

Sep.29.2011……New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma in the U.S.

Sep.26.2011……Approval received for an Intravenous Antiemetic Selective Neurokinin-1(NK1)Receptor Antagonist,"PROEMEND® Intravenous infusion 150mg"

Sep.21.2011……Ono and Bristol-Myers Squibb Enter into Strategic Agreement for Anti-PD-1 Antibody,ONO-4538/BMS-936558,and ORENCIA®(abatacept),Rheumatoid Arthritis Agent

Sep.16.2011……Glactiv® has received approval for the additional indication of combination use with insulin

Sep.15.2011……Ono Enters License Agreement with KAI Phamaceuticals,Inc.for KAI 4169

Sep.15.2011……Launch of RECARBON® Tablets 50mg/Bonoteo® Tablet 50mg,Once per 4week Oral Osteoposis Treatment in Japan

Sep.14.2011……Ono Enters into License Agreement with Servier for Ivabradine

Sep.14.2011……Launch of Corebeta® for Injection 12.5mg for Improvement of Image Quality in Coronary CT Angiography in Japan

Aug.24.2011……Helsinn Announced to have Initiated Global Pivotal Phase III Clinical Program to Evaluate Anamorelin (ONO-7643/RC-1291) in Non-Small Cell Lung Cancer-Associated Anorexia/Cachexia

Jul.19.2011……Launch of Rivastach® Patch,for the Treatment of Dementia of Alzheimer's Type

Jul.01.2011……Approval for RECARBON® Tablets 50mg/Bonoteo® Tablet 50mg, Once per 4weeks Oral Osteoposis treatment in Japan

Jul.01.2011……Approval for Corebeta® for Injection 12.5mg for Improvement of Image Quality in Coronary CT Angiography in Japan

Jun.27.2011……Lead Compounds Were Successfully Identified in Ion Channel Drug Discovery Collaboration with Evotec

Jun.01.2011……Announcement on Co-development and Co-marketing Agreement for Carpal-tunnel Syndrome, an Additional Indication of Limaprost, an Oral Prostaglandin E1 Analogue

May.23.2011……Approval for Additional Indication Application of Type-2 Diabetes Drug,Glactiv Tablets
-Combination Therapy with Alpha-glucosidase Inhibitors-

May.11.2011……Announcement on Financial Results for FY2010

May.11.2011……Announcement on Introduct of Corporate Officer System,Changes of Members of the Board of Directors and Appointment of Corporate Officers

Apr.22,2011……Approval Received for Rivastach® Patch, for the treatment of Alzheimer's disease

Apr.06,2011……Announcement on Cancellation of the Company's Own Shares

Apr.05,2011……Launch of Orally Disintegrating Tablet of Staybla Tablets 0.1mg, a Drug for Overactive Bladder

Mar.29,2011……Ono Enters into License Agreement with OncoTherapy for New Therapeutic Cancer Peptide Vaccines

Mar.25,2011……Announcement on Results and Completion of Acquisition of the Company's Own Shares

Jan.11,2011……Ono and Galapagos subsidiary BioFocus sign target discovery agreement in the field of autoimmune disease

Dec.10,2010……Results of Phase Ⅱb Study of Carfizomib were Presented at the 52nd American Society of Hematology Annual Meeting

Nov.11,2010……Approval Received for Orally Disintegrating Tablet of imidafenacin (INN), a Drug for Overactive Bladder

Nov.04,2010……Announcement on Acquisition of the Company's Own Shares

Oct.28,2010……Ono and MSD Submit Additional Indication Application for Sitagliptin Combination Therapy with Insulin

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