(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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1 R&D Pipeline (November 2011) 1. Global Development (1) Approved telavancin Product Name (Approval Date) VIBATIV (Sep. 2011) Classification Lipoglycopeptide antibiotic Therapeutic Target 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 Area Europe Theravance (2) Filed Stage in the most advanced territory telavancin Lipoglycopeptide antibiotic Nosocomial pneumonia MRSA infections US Filed * (Jan. 2009) Theravance YM178 mirabegron Beta 3 receptor agonist Overactive bladder associated with symptoms of urgency, urinary frequency, and urge urinary incontinece US Filed Europe Filed *Received a Complete Response letter from the FDA in November 2009, and the second Complete Response letter in December
2 (3) Phase-lll / Phase-ll (1/3) Stage in the most advanced territory EC905 solifenacin/ tamsulosin Concomitant use of solifenacin and tamsulosin Lower urinary tract symptoms associated with benign prostatic hyperplasia I MDV3100 Androgen antagonist Prostate cancer I I II Asia Phase-III Medivation ASP1941 ipragliflozin SGLT2 inhibitor Type 2 diabetes II (codevelopment 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) Adrenocortical carcinoma I OSI-906 IGF-1R/IR tyrosine kinase inhibitor Ovarian cancer, Non-small cell lung cancer, Hepatocellular carcinoma (OSI) ASP4130 tivozanib Triple VEGF receptors inhibitor Renal cell carcinoma Breast cancer, Colorectal cancer US/I US/ AVEO 12
3 (3) Phase-lll / Phase-ll (2/3) Stage in the most advanced territory 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 YM155 Survivin suppressant Breast cancer, Non-Hodgkin's lymphoma AC220 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) ASP015K Immunosuppressant Prevention of organ transplant rejection ASKP1240 Anti-CD40 antagonist Prevention of organ transplant rejection Kyowa Hakko Kirin OSI-027 mtor kinase inhibitor Renal cell cancer (OSI) 13
4 (3) Phase-lll / Phase-ll (3/3) Stage in the most advanced territory PSN821 GPR119 agonist Type 2 diabetes, Obesity (OSI) YM905 solifenacin Muscarine M 3 receptor antagonist Neurogenic detrusor overactivity and idiopathic overactive bladder in pediatric patients US/ 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 14
5 2. Local Development: Japan (1) Filed The most advanced stage ASP8825 (XP13512) gabapentin enacarbil YM443 acotiamide Prodrug of gabapentin Acetylcholine esterase inhibitor Restless legs syndrome Functional dyspepsia (Nov. 2009) (Sep. 2010) XenoPort Zeria ASP3550 degarelix Prostate cancer (One-month formulation) (Oct. 2010) GnRH receptor antagonist Ferring Prostate cancer (Three-month formulation) I ASP1585 (AMG223) bixalomer Amine-functional phosphate-binding polymer Hyperphosphatemia in patients with chronic kidney disease on dialysis (Mar. 2011) Ilypsa/Amgen YM177 celecoxib Cyclooxygenase-II inhibitor Anti-inflammatory and analgesic effects in post-operation, posttrauma, and post-tooth extraction (Mar. 2011) Pfizer amoxicillin Penicillin antibiotic Pediatric infectious diseases (changes in the maximum dosages) Additional dosage and administration 15
6 (2) Phase-lll / Phase-ll YM533 beraprost sodium Prostacyclin receptor stimulator Chronic renal failure (primary, nephrosclerosis) Japan/Asia Phase-III Toray FK949E quetiapine Serotonin/dopamine antagonist Depressive episode in bipolar disorders Major depressive disorder II I AstraZeneca YM060 ramosetron Irritable bowel syndrome Female patients I 5-HT3 receptor antagonist Irritable bowel syndrome Japan (ly-disintegrating tablet) Bio-equivalent study 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) Filed fidaxomicin Macrocyclic antibiotic Clostridium difficile infection Europe Filed* (Jul. 2010) Optimer *Received CHMP positive opinion in September
7 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 ASP4178 Type 2 diabetes 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 17
8 5. Project Discontinued Area / Phase Therapeutic Target Reason YM150 darexaban Japan/Asia Phase-III Japan/Asia Phase-II Prevention of venous thromboembolism after major orthopedic surgery Prophylaxis of thromboembolic complications associated with atrial fibrillation Acute coronary syndrome Astellas had been considering the appointment of a partner for the Phase III clinical development and commercialization of darexaban. However, Astellas concluded that finding a suitable partner has been difficult and considering intensified competition for this product and the order of priority in its pipeline, Astellas has decided to discontinue development of darexaban. 18
9 <Changes from the Previous Announcement on August 1, 2011> Launched -Removed Betanis from the list, because it was launched in Japan in September. -Removed Bonoteo [50 mg] from the list, because it was launched in Japan in September. -Removed Prograf/Graceptor from the list. It was approved for new indication in Japan in July. Product Name (Approval Date) Classification Therapeutic Target Area YM178 mirabegron Betanis (Jul. 2011) Beta 3 receptor agonist Urgency, urinary frequency, and urinary incontinence associated with overactive bladder Japan YM529 minodronic acid Bonoteo [50 mg] (Jul. 2011) Bisphosphonate Osteoporosis (Once per 4 weeks) Japan (co-development with Ono) FK506 tacrolimus Prograf Graceptor (Jul. 2011) Immunosuppressant Prophylaxis of organ rejection in patients receiving allogenic small bowel transplants Japan Approval -Updated the description for telavancin, because it was approved in Europe for the following indication. Product Name (Approval Date) Classification Therapeutic Target Area telavancin VIBATIV (Sep. 2011) Lipoglycopeptide antibiotic Treatment of adults with nosocomial pneumonia (hospitalacquired), including ventilator associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable Europe Theravance 19
10 Filed -Updated the area for telavancin, because the indication of nosocomial pneumonia was approved in Europe. (Underlined) telavancin Lipoglycopeptide antibiotic Nosocomial pneumonia US Filed * (Jan. 2009) *Received a Complete Response letter from the FDA in November 2009, and the second Complete Response letter in December Theravance -Updated the phase of YM178, because it was filed in US and Europe. YM178 mirabegron Beta 3 receptor agonist Overactive bladder associated with symptoms of urgency, urinary frequency, and urge urinary incontinece US Filed Europe Filed -Added Amoxicillin, because it was filed in Japan. Classification Therapeutic Target Area / Phase amoxicillin Penicillin antibiotic Pediatric infectious diseases (changes in the maximum dosages) Additional dosage and administration -Added a footnote for fidaxomicin (Underlined). fidaxomicin Macrocyclic antibiotic Clostridium difficile infection Europe Filed* (Jul. 2010) Optimer *Received CHMP positive opinion in September
11 Phase-III / Phase-II -Updated the phase of ASP4130, because it entered into phase-ii in US and Europe (Underlined). ASP4130 tivozanib Triple VEGF receptors inhibitor Renal cell carcinoma Breast cancer, Colorectal cancer US/Europe Phase-III US/Europe Phase-II AVEO -Updated the description of FK949E, because it entered into phase-iii for depressive episode in bipolar disorders and phase-ii for major depressive disorder in Japan. FK949E quetiapine Serotonin/dopamine antagonist Depressive episode in bipolar disorders Major depressive disorder II I AstraZeneca Phase-I (Newly Developed) -Added ASP9226 [Neuropathic pain] to the phase-i list. Project Discontinued -Deleted YM150 due to the discontinuation of the development for all indications. 21
(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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