Changes from Third Quarter Flash Report for the Fiscal Year ending March 2015 announced on February 3, 2015 *1: Marketing authorization of Onoact 150
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1 Annual Flash Report (unaudited) Fiscal Year ended March 31, 2015 Supplemental Information Status of Development Pipeline as of May 12, 2015 I. Main Pipelines Other than ONO-4538 ⅰ. Developments Status in Approved Onoact 150 mg (ONO-1101)*1 Additional formulation Intraoperative tachyarrhythmia, Post operative tachyarrhythmia under monitoring hemodynamics, tachyarrhythmia in low cardiac function [Short acting beta 1 blocker] Filed Rivastach Patch (ONO-2540 / ENA713D) Additional Dosing Regimen Alzheimer s disease [dual inhibitor of AChE and BuChE] Transdermal patch In-license (Novartis Pharma AG) Ongoing clinical studies Proemend for i.v. infusion (ONO-7847 / MK-0517) Additional indication for pediatric use Chemotherapy-induced nausea and vomiting in pediatric patients [NK1 receptor antagonist] / II In-license (Merck & Co., Inc.) Orencia IV (ONO-4164 / BMS ) Additional indication Juvenile Rheumatoid Arthritis [T-cell activation inhibitor] / II In-license (Bristol- Orencia IV (ONO-4164 / BMS ) Additional indication Lupus nephritis[t-cell activation inhibitor] / II In-license (Bristol- ONO-7057 / Carfilzomib Multiple Myeloma [Proteasome inhibitor] / II In-license (Onyx Pharmaceuticals, Inc.) ONO-5163 / AMG-416 Secondary hyperparathyroidism [Calcium sensing receptor agonist] / II In-license (Amgen Inc.) Onoact 50 mg / 150 mg (ONO- 1101)*2 Additional indication for pediatric use Tachyarrhythmia in low cardiac function [Short acting beta 1 blocker] / I/III ONO-7643 / RC-1291 Cancer anorexia/cachexia [Ghrelin mimetic] / I In-license (Helsinn Healthcare, S.A.) ONO-1162 / Ivabradine Chronic heart failure [If channel inhibitor] / I In-license (Les Laboratoires Servier) Ongoing clinical studies ONO-6950 Bronchial asthma [LT receptor antagonist] / I ONO-4053 Allergic rhinitis [PGD2 receptor antagonist] / I ONO-7056 / Salirasib Solid tumor [Ras signal inhibitor] / In-license (Kadmon Corporation LLC) ONO-7268 MX1 Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / In-license (OncoTherapy Science, Inc.) ONO-7268 MX2 Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / In-license (OncoTherapy Science, Inc.) ONO-2160/CD Parkinson s disease [levodopa pro-drug] / ONO-2370 / Opicapone Parkinson s disease [Long acting COMT inhibitor] / In-license (Bial) ONO-4059 B cell lymphoma [Bruton s tyrosine kinase (Btk) inhibitor] / ONO-5371 / Metyrosine Pheochromocytoma [Tyrosine hydroxylase inhibitor] / In-license (Valeant Pharmaceuticals North America LLC.) 12
2 Changes from Third Quarter Flash Report for the Fiscal Year ending March 2015 announced on February 3, 2015 *1: Marketing authorization of Onoact 150 mg (Short acting beta 1 blocker) (high content formulation) was obtained in for the purpose of improvement in convenience. *2: I/III of Onoact 50 mg/150 mg (Short acting beta 1 blocker) was initiated for tachyarrhythmia in pediatric low cardiac function. Note: compounds include a compound generated from collaborative research. ⅱ. Developments Status outside Ongoing clinical studies ONO-6950 Bronchial asthma [LT receptor antagonist] / I ONO-4053 Allergic rhinitis [PGD2 receptor antagonist] / I ONO-2952 Irritable bowel syndrome [TSPO antagonist] / I ONO-9054 Glaucoma, ocular hypertension [PG receptor (FP / EP3) agonist] / I Eye drop ONO-4059 B cell lymphoma [Bruton s tyrosine kinase (Btk) inhibitor] / ONO-8055 Underactive bladder [PG receptor (EP2 / EP3) agonist] / ONO-1266 Portal hypertension [S1P receptor antagonist] / ONO-4232 Acute heart failure [PG receptor (EP4) agonist] / ONO-4474 *1 Osteoarthritis [Tropomyosin receptor kinase (Trk) inhibitor] / Changes from Third Quarter Flash Report for the Fiscal Year ending March 2015 announced on February 3, 2015 *1: of ONO-4474 / Osteoarthritis (Tropomyosin receptor kinase (Trk) inhibitor) was initiated in healthy adult volunteers. *2: Development of ONO-8539 (PG receptor (EP1) antagonist) was discontinued due to no expected treatment effect. Note: compounds include a compound generated from collaborative research. 13
3 II. Main Pipelines ONO-4538 etc ⅰ. Developments Status in,, and Approved Development Indications Area / In-license (ONO-4538) /BMS *1 Ipilimumab In-license (Bristol- In-license (Bristol- *1: Marketing authorization of was obtained in for the treatment of unresectable or metastatic melanoma with disease progression. Note: compounds include a compound generated from collaborative research. Filed Development Indications Area / In-license (ONO-4538) /BMS Non-small cell lung cancer *2 Ipilimumab In-license (Bristol- *2: was filed in and for the treatment of non-small cell lung cancer (except nonsquamous cell carcinoma). Note: compounds include a compound generated from collaborative research. 14
4 Ongoing clinical studies (ONO-4538) / BMS Development Indications Clinical Stage Renal cell cancer II Non-small cell lung cancer Head and neck cancer Gastric cancer II II II Esophageal cancer I Hodgkin s lymphoma I Hepatocellular carcinoma*3 Area / In-license Myers Squibb Company and Solid tumor (combination with Mogamulizumab) *4 Kyowa Hakko Kirin) Changes from Third Quarter Flash Report for the Fiscal Year ending March 2015 announced on February 3, 2015 *3: of Opdivo was initiated for the treatment of hepatocellular carcinoma. *4: was initiated for the treatment of Solid tumor (combination with Mogamulizumab) by Kyowa Hakko Kirin. Note: compounds include a compound generated from collaborative research. 15
5 ⅱ. Developments Status in and the United States Approved (ONO-4538) / BMS Development Indications Area / In-license Non-small cell lung cancer *1 *1: Marketing authorization of was obtained in for the treatment of squamous non-small cell lung cancer. Note: compounds include a compound generated from collaborative research. Filed (ONO-4538) / BMS Development Indications Area / In-license Non-small cell lung cancer Note: compounds include a compound generated from collaborative research. 16
6 Ongoing clinical studies (ONO-4538) / BMS Development Indications Renal cell cancer Head and neck cancer Glioblastoma Diffuse large B cell lymphoma Follicular lymphoma Hodgkin s lymphoma Bladder cancer *2 Colon cancer Solid tumors (triple negative breast cancer, gastric cancer, pancreatic cancer, small cell lung cancer, bladder cancer) Hepatocellular carcinoma Hematologic cancer (T-cell lymphoma, multiple myeloma, chronic leukemia, etc.) Chronic myeloid leukemia Clinical Stage III III III I I I I I/II I/II Area / In-license Hepatitis C *2: I was initiated for the treatment of bladder cancer by Bristol-Myers Squibb Company. Note: compounds include a compound generated from collaborative research. 17
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