(2) Phase-lll / Phase-ll (2/3) ASP7487 (OSI-906) linsitinib IGF-1R/IR tyrosine kinase inhibitor Adrenocortical carcinoma Ovarian cancer, Non-small cel
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1 R&D Pipeline (February 2012) 1. Global Development (1) Filed YM178 mirabegron Beta 3 receptor agonist Overactive bladder associated with symptoms of urgency, urinary frequency, and urge urinary incontinece US Filed (Aug. 2011) Europe Filed (Aug. 2011) (2) Phase-lll / Phase-ll (1/3) Stage in the most advanced territory EC905 solifenacin/ tamsulosin Fixed dose combination of solifenacin and tamsulosin Lower urinary tract symptoms associated with benign prostatic hyperplasia, with storage symptoms I MDV3100 Androgen antagonist Prostate cancer I I II Asia Phase-III Medivation ASP1941 ipragliflozin SGLT2 inhibitor Type 2 diabetes II (co-development with Kotobuki) isavuconazole Azole antifungal Invasive aspergillosis Candidemia / Invasive candidiasis US/I US/I Basilea erlotinib (Tarceva) HER1/EGFR tyrosine kinase inhibitor Non-small cell lung cancer (First line for patients with EGFR mutation, adjuvant), Hepatocellular carcinoma I (OSI) 22
2 (2) Phase-lll / Phase-ll (2/3) ASP7487 (OSI-906) linsitinib IGF-1R/IR tyrosine kinase inhibitor Adrenocortical carcinoma Ovarian cancer, Non-small cell lung cancer I Stage in the most advanced territory (OSI) ASP4130 tivozanib Triple VEGF receptors inhibitor Renal cell carcinoma Breast cancer, Colorectal cancer US/I US/ AVEO ASP0113 (VCL-CB01) DNA vaccine for cytomegalovirus Cytomegalovirus reactivation in hematopoietic stem cell transplant recipients Cytomegalovirus infection or reactivation in solid organ transplant recipients US/I US/ Vical YM905 solifenacin Muscarine M 3 receptor antagonist Neurogenic detrusor overactivity and idiopathic overactive bladder in pediatric patients US/I YM155 Survivin suppressant Breast cancer, Non-Hodgkin's lymphoma AC220 quizartinib FLT3 kinase inhibitor Acute myeloid leukemia Ambit ASP1517 (FG-4592) HIF stabilizer Renal anemia FibroGen YM311 (FG-2216) HIF stabilizer Renal anemia FibroGen AGS-1C4D4 Antibody (Prostate stem cell antigen) Pancreatic cancer US/ (Agensys) 23
3 (2) Phase-lll / Phase-ll (3/3) US/ Rheumatoid arthritis I ASP015K JAK inhibitor Prevention of organ transplant rejection Stage in the most advanced territory ASKP1240 Anti-CD40 antagonist Prevention of organ transplant rejection Kyowa Hakko Kirin OSI-027 mtor kinase inhibitor Renal cell cancer PSN821 GPR119 agonist Type 2 diabetes, Obesity (OSI) (OSI) ASP8597 diannexin Inhibition of monocyte and platelet binding to phosphatidylserine Prevention of delayed graft function in kidney transplantation Alavita EB178 solifenacin/ mirabegron Concomitant use of solifenacin and mirabegron Urinary frequency, urinary incontinence or urgency associated with overactive bladder ASP3652 Inhibition of afferent nerve activity Chronic prostatitis / Chronic pelvic pain syndrome Bladder pain syndrome / Interstitial cystitis 24
4 2. Local Development: Japan (1) Approved Product Name (Approval Date) Classification Therapeutic Target Area YM177 celecoxib Celecox (Dec. 2011) Cyclooxygenase-II inhibitor Anti-inflammatory and analgesic effects in post-operation, posttrauma, and post-tooth extraction Japan Pfizer ASP8825 (XP13512) gabapentin enacarbil Regnite (Jan. 2012) Prodrug of gabapentin Moderate-to-severe primary restless legs syndrome Japan XenoPort (2) Filed The most advanced stage YM443 acotiamide ASP3550 degarelix Acetylcholine esterase inhibitor GnRH receptor antagonist Functional dyspepsia Prostate cancer (One-month formulation) Prostate cancer (Three-month formulation) Japan Filed (Sep. 2010) Japan Filed (Oct. 2010) I Zeria Ferring New formulation ASP1585 (AMG223) bixalomer Amine-functional phosphate-binding polymer Hyperphosphatemia in patients with chronic kidney disease on dialysis Japan Filed (Mar. 2011) Ilypsa/Amgen amoxicillin Penicillin antibiotic Pediatric infectious diseases (Changes in the maximum dosages) Japan Filed (Aug. 2011) Additional dosage and administration 25
5 (3) Phase-lll / Phase-ll YM533 beraprost sodium Prostacyclin receptor stimulator Chronic renal failure (primary, nephrosclerosis) Japan/Asia Phase-III Stage in the most advanced territory Toray New formulation FK949E quetiapine Serotonin/dopamine antagonist Depressive episode in bipolar disorders Major depressive disorder II I AstraZeneca New formulation YM060 ramosetron 5-HT3 receptor antagonist Irritable bowel syndrome Female patients Irritable bowel syndrome (ly-disintegrating tablet) I Japan Bio-equivalent study New formulation ASP7373 Influenza vaccine Prophylaxis of H5N1 influenza I UMN Pharma ASP7374 Influenza vaccine Prophylaxis of seasonal influenza I UMN Pharma 3. Local Development: Europe (1) Approved Product Name (Approval Date) Classification Therapeutic Target Area fidaxomicin DIFICLIR (Dec. 2011) Macrocyclic antibiotic Treatment of clostridium difficile infection Europe Optimer 26
6 4. Phase-l Therapeutic Target AGS-16M8F Cancer (ADC technology) (Agensys) ASG-5ME Cancer (ADC technology) (Agensys) (co-development with Seattle Genetics) ASP7035 Nocturia ASP0777 Alzheimer s disease [Dementia] ASP3291 Ulcerative colitis ASP5034 Type 2 diabetes ASP1707 Prostate cancer, Endometriosis ASP0306 Lower urinary tract symptoms associated with benign prostatic hyperplasia ASP4058 Multiple sclerosis ASP0456 linaclotide ASP4901 (AKP-002) Irritable bowel syndrome Ironwood Lower urinary tract symptoms associated with benign prostatic hyperplasia ASKA ASP8477 Neuropathic pain ASP2408 Rheumatoid arthritis (Perseid) ASP3026 Cancer ASP9521 Prostate cancer AGS-22M6E Cancer (ADC technology) (Agensys) (co-development with Seattle Genetics) ASP7147 Irritable bowel syndrome ASP9226 Neuropathic pain ASP9603 Prostate cancer ASP7991 Secondary hyperparathyroidism ASP2409 Prevention of organ transplant rejection (Perseid) 27
7 5. Project Discontinued Area / Phase Therapeutic Target Reason telavancin Europe Approved US Filed * Treatment of adults with nosocomial pneumonia (hospital-acquired), including ventilator associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable Nosocomial pneumonia Development was discontinued because we have terminated the global License, Development and Commercialization Agreement for telavancin. MRSA infections ASP4178 Phase-I Type 2 diabetes We have decided to discontinue the in-house development and to seek a partner, considering comprehensively our focus area and pipeline prioritization. *Received a Complete Response letter from the FDA in November 2009, and the second Complete Response letter in December
8 <Changes from the Previous Announcement on November 1, 2011> Approved -YM177: Approved in Japan for new indication. Product Name (Approval Date) Classification Therapeutic Target Area YM177 celecoxib Celecox (Dec. 2011) Cyclooxygenase-II inhibitor Anti-inflammatory and analgesic effects in postoperation, post-trauma, and post-tooth extraction Japan Pfizer -ASP8825: Approved in Japan. Product Name (Approval Date) Classification Therapeutic Target Area ASP8825 (XP13512) gabapentin enacarbil Regnite (Jan. 2012) Prodrug of gabapentin Moderate-to-severe primary restless legs syndrome Japan XenoPort -Fidaxomicin: Approved in Europe. Product Name (Approval Date) Classification Therapeutic Target Area fidaxomicin DIFICLIR (Dec. 2011) Macrocyclic antibiotic Treatment of clostridium difficile infection Europe Optimer 29
9 Phase-III / Phase-II -EC905: Changed the description of classification and therapeutic target. (Underlined) EC905 solifenacin/ tamsulosin Fixed dose combination of solifenacin and tamsulosin Lower urinary tract symptoms associated with benign prostatic hyperplasia, with storage symptoms I -YM905: Entered into phase-iii. (Underlined) YM905 solifenacin Muscarine M 3 receptor antagonist Neurogenic detrusor overactivity and idiopathic overactive bladder in pediatric patients US/Europe Phase-III -ASP015K: Entered into phase-ii for rheumatoid arthritis in US/Europe and Japan, and changed the classification from immunosuppressant to JAK inhibitor. (Underlined) US/Europe Rheumatoid arthritis Phase-II ASP015K JAK inhibitor I Prevention of organ transplant rejection 30
10 -ASP3652: Entered into phase-ii for bladder pain syndrome / interstitial cystitis in Europe. (Underlined) ASP3652 Inhibition of afferent nerve activity Chronic prostatitis / Chronic pelvic pain syndrome Bladder pain syndrome / Interstitial cystitis -ASP7487 (OSI-906): Deleted hepatocellular carcinoma from the therapeutic target because we discontinued the development in it, which was in phase-ii. (Changed underlined part) ASP7487 (OSI-906) linsitinib IGF-1R/IR tyrosine kinase inhibitor Adrenocortical carcinoma Ovarian cancer, Non-small cell lung cancer I (OSI) Phase-I (Newly Developed) -Added ASP9603 [Prostate cancer] to the Phase-I list. -Added ASP7991 [Secondary hyperparathyroidism] to the Phase-I list. -Added ASP2409 [Prevention of organ transplant rejection] to the Phase-I list. Project Discontinued -Deleted telavancin from the list because we terminated the license agreement with Theravance and discontinued the development. -Deleted ASP4178 due to the development discontinuation. 31
(3) Phase-lll / Phase-ll (1/3) Stage in the most advanced territory EC905 solifenacin/ tamsulosin Concomitant use of solifenacin and tamsulosin Lower
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