R&D Pipeline (May 2010)

Transcription

1 R&D Pipeline (May 2010) 1 Global development (1) Filed Stage in the Most Advanced Territory YM617 tamsulosin Alpha-1 receptor antagonist Lower urinary tract syndrome in male patients (June 2007) New indication telavancin Lipoglycopeptide antibiotic Complicated skin and soft tissue infections (cssti) Nosocomial pneumonia (NP) MRSA infections Urinary frequency, urinary YM905 Muscarine M 3 receptor incontinence or urgency associated solifenacin antagonist with overactive bladder (orally-disintegrating tablet) *Received a Complete Response letter from the FDA in November 2009 Europe Filed (Oct 2009) USA Filed* (Jan 2009) Europe Filed (Oct 2009) (Dec 2009) Theravance New formulation 12

2 (2) Phase-III/ Phase-II -1 Stage in the Most Advanced Territory YM178 mirabegron YM150 Beta 3 receptor agonist Factor Xa inhibitor Urinary frequency, urinary incontinence or urgency associated with overactive bladder Prevention of venous thromboembolism (VTE) after major orthopedic surgery Prophylaxis of thromboembolic complications associated with atrial fibrillation (AF) Acute coronary syndrome (ACS) I I II Japan/Asia Phase-III Japan/Asia Phase-II solifenacin/ tamsulosin Concomitant use of solifenacin and tamsulosin Lower urinary tract syndrome associated with benign prostatic hyperplasia (BPH) MDV3100 Androgen antagonist Prostate cancer ASP1941 SGLT2 inhibitor Type 2 diabetes I I I Japan Phase- III Medivation (co-development with Kotobuki) Isavuconazole YM155 Azole antifungal Survivin suppressant Invasive aspergillosis Candidemia/ Invasive candidiasis Breast cancer, Non-Hodgkin s lymphoma, Melanoma AC220 FLT3 kinase inhibitor Acute Myeloid Leukemia Basilea Ambit 13

3 (2) Phase-III/ Phase-II -2 Stage in the Most Advanced Territory ASP2151 Helicase-primase inhibitor Herpes zoster, Genital herpes I ASP0485 alefacept Immunosuppressant Prophylaxis of kidney transplant rejection ASP9831 PDE4 inhibitor Non-alcoholic steatohepatitis YM311 (FG-2216) HIF stabilizer Renal anemia FibroGen ASP1517 (FG-4592) HIF stabilizer Renal anemia FibroGen YM060 ramosetron 5-HT3 receptor antagonist Irritable bowel syndrome (IBS) AGS-1C4D4 ASP6183 (AGS-8M4) ASP015K ASKP1240 Antibody (Prostate stem cell antigen) Antibody binds to human chondrolectin (AGS-8) Immunosuppressant Anti-CD40 antagonist Pancreatic cancer USA/ Ovarian cancer Suppression of organ rejection in organ transplant Suppression of organ rejection in organ transplant Kyowa Hakko Kirin 14

4 2 Local development: Japan (1) Filed ASP8825 (XP13512) Prodrug of gabapentin Restless legs syndrome (Nov 2009) XenoPort (2) Phase-III/ Phase-II YM529 minodronate ASP1585 (AMG223) YM177 celecoxib YM533 beraprost sodium YM443 acotiamide ASP3550 degarelix Bisphosphonate Non-absorbed, polymer-based phosphate binder Osteoporosis (intermittent administration) II (co-development with Ono) Hyperphosphatemia II Ilypsa/Amgen New formulation Cyclooxygenase-II inhibitor Acute pain II Pfizer New indication Prostacyclin receptor stimulator Acetylcholine esterase inhibitor Chronic renal failure (primary, nephrosclerosis) Japan/Asia Phase-III Toray Functional dyspepsia II Zeria GnRH receptor antagonist Prostate cancer I Ferring New indication New formulation 3 Local development: USA (1) Filed RSD1235 vernakalant Antiarrhythmic agent *Received an approvable letter from the FDA in August 2008 Atrial fibrillation (AF) USA Filed (Dec 2006)* Cardiome 15

5 4 Phase-I ASP2905 Therapeutic Target Alzheimer s disease (Dementia), Schizophrenia AGS-16M18 Cancer AGS-6MF ASG-5ME Cancer (ADC) Cancer (ADC) (Co-development with Seattle Genetics) ASP3652 Overactive bladder ASP7035 Nocturia ASP0777 Alzheimer s disease (Dementia) ASP3291 Ulcerative colitis FK949E Major depressive disorder AstraZeneca ASP4178 Type 2 diabetes ASP5034 Type 2 diabetes 5 Discontinued YM086 (BIBR277) telmisartan Area / Phase Therapeutic Target Reason (June 2006) Type 2 diabetic nephropathy The decision for the withdrawal of application for approval was made because currently submitted data is insufficient to establish an evidence that is necessary to attain the approval, as a result of discussion with Pharmaceuticals and Medical Devices Agency ASP0265 Phase-I Prostate cancer, Endometriosis Considering the results of Phase-I, discontinuation of development was decided 16

6 Changes from the previous announcement (Financial results announcement on February 2, 2010) - YM086 was deleted from the list because the application for approval was withdrawn and the development was discontinued YM086 (BIBR277) telmisartan Angiotensin II receptor blocker Type 2 diabetic nephropathy (June 2006) Boehringer Ingelheim New indication - Listed Isavuconazole, licensed from Basilea as Phase-III in USA and Europe Isavuconazole Azole antifungal Invasive aspergillosis Candidemia/ Invasive candidiasis Basilea - ASKP1240: Entry into Phase-II in USA from Phase-I ASKP1240 Anti-CD40 antagonist Suppression of organ rejection in organ transplant Kyowa Hakko Kirin - Listed ASG-5ME {Cancer, (Co-development with Seattle Genetics)} as Phase-I - Listed ASP5034 (Type 2 diabetes, ) as Phase-I - ASP0265 (Prostate cancer, Endometriosis, Phase-I) was deleted from the list because the the development was discontinued 17