08 05-12 astellas rd-q1

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08 05-12 astellas rd-q1

  1. 1. R&D Pipeline (August 2012)1. Global Development(1) Approved Code No. Product Name Dosage Classification Target Disease Area Origin RemarksGeneric Name (Approval Date) Form Overactive bladder associated YM178 Myrbetriq with symptoms of urgency, Beta 3 receptor agonist US Oral In-house mirabegron (Jun. 2012) urinary frequency, and urge urinary incontinence(2) Filed Stage in the most advanced territory Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form Overactive bladder associated with YM178 symptoms of urgency, Europe Filed Beta 3 receptor agonist Oral In-house mirabegron urinary frequency, (Aug. 2011) and urge urinary incontinence US Filed Metastatic castration-resistant (May 2012) prostate cancer who have received Europe Filed docetaxel-based chemotherapy (Jun. 2012) MDV3100 Androgen receptor Japan Phase-II Oral Medivation enzalutamide* signaling inhibitor US Phase-III Prostate cancer Europe Phase-III New indication (Chemotherapy-naive etc.) Japan Phase-III Asia Phase-III Breast cancer US Phase-I New indication*p-INN (proposed international nonproprietary name) 21
  2. 2.  (3) Phase-lll/ Phase-ll (1/3) Stage in the most advanced territory Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form Japan Phase-III In-house ASP1941 SGLT2 inhibitor Type 2 diabetes US Phase-II Oral (co-development ipragliflozin Europe Phase-II with Kotobuki) Invasive aspergillosis US/Europe Phase-III Injection isavuconazole Azole antifungal Basilea Candidemia/ Invasive candidiasis US/Europe Phase-III Oral Non-small cell lung cancer (First line for patients with EGFR erlotinib HER1/EGFR mutation, adjuvant, combination US Phase-III Oral In-house (OSI) New indication (Tarceva) tyrosine kinase inhibitor with MetMab), Colorectal carcinoma, Pediatric ependymoma Inhibitor of vascular Renal cell carcinoma US/Europe Phase-III ASP4130 endothelial growth Oral AVEO tivozanib factor (VEGF) receptors 1, 2 and 3 Colorectal cancer, Breast cancer US/Europe Phase-II Cytomegalovirus reactivation in hematopoietic stem cell US/Europe Phase-III transplant recipients ASP0113 DNA vaccine for Injection Vical (VCL-CB01) cytomegalovirus Cytomegalovirus infection or reactivation in solid organ US/Europe Phase-II transplant recipients Neurogenic detrusor overactivity YM905 Muscarine M3 receptor and idiopathic overactive bladder US/Europe Phase-III Oral In-house New indication solifenacin antagonist in pediatric patients 22
  3. 3.  (3) Phase-lll/ Phase-ll (2/3) Stage in the most advanced territory Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form ASP7487 IGF-1R/IR tyrosine kinase Ovarian cancer, (OSI-906) US Phase-II Oral In-house (OSI) inhibitor Non-small cell lung cancer linsitinib YM155 US Phase-II Breast cancer, sepantronium Survivin suppressant Europe Phase-II Injection In-house Non-Hodgkins lymphoma bromide Japan Phase-I AC220 US Phase-II FLT3 kinase inhibitor Acute myeloid leukemia Oral Ambit quizartinib Europe Phase-II ASP1517 Europe Phase-II HIF stabilizer Renal anemia Oral FibroGen (FG-4592) Japan Phase-I YM311 Europe Phase-II HIF stabilizer Renal anemia Oral FibroGen (FG-2216) Japan Phase-I Antibody In-house AGS-1C4D4 Pancreatic cancer US/Europe Phase-II Injection (Prostate stem cell antigen) (Agensys) US/Europe Phase-II Rheumatoid arthritis Japan Phase-II ASP015K JAK inhibitor Oral In-house Prevention of organ transplant US Phase-II rejection Prevention of organ transplant US Phase-II Kyowa Hakko ASKP1240 Anti-CD40 antagonist Injection rejection Japan Phase-I Kirin OSI-027 mTOR kinase inhibitor Renal cell cancer US Phase-II Oral In-house (OSI) 23
  4. 4.  (3) Phase-lll/ Phase-ll (3/3) Stage in the most advanced territory Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form PSN821 GPR119 agonist Type 2 diabetes, Obesity Europe Phase-II Oral In-house (OSI) Inhibition of monocyte and ASP8597 Prevention of delayed graft function platelet binding to US Phase-II Injection Alavita diannexin in kidney transplantation phosphatidylserine EB178 Urinary frequency, urinary Concomitant use of solifenacin/ incontinence or urgency associated Europe Phase-II Oral In-house solifenacin and mirabegron mirabegron with overactive bladder Chronic prostatitis/ Europe Phase-II Inhibition of afferent nerve Chronic pelvic pain syndrome Japan Phase-I ASP3652 Oral In-house activity Bladder pain syndrome/ Europe Phase-II Interstitial cystitis Europe/Japan Endometriosis Phase-II ASP1707 GnRH antagonist Oral In-house Prostate cancer Europe Phase-I 24
  5. 5. 2. Local Development: Japan(1) Approved Code No. Product Name Dosage Classification Target Disease Area Origin RemarksGeneric Name (Approval Date) Form ASP3550 Gonax Prostate cancer GnRH antagonist Japan Injection Ferring degarelix (Jun. 2012) (One-month formulation)(2) Filed Stage in the most advanced territory Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form YM443 Acetylcholine esterase Japan Filed Functional dyspepsia Oral Zeria acotiamide inhibitor (Sep. 2010) Rheumatoid arthritis in patients Japan Filed PEGylated anti-tumor who respond insufficiently to certolizumab (Jan. 2012) necrosis factor-alpha current therapies Injection UCB pegol antibody Methotrexate-naive Japan Phase-III New indication rhumatoid arthritis 25
  6. 6.  (3) Phase-lll/ Phase-ll Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form YM533 Prostacyclin receptor Chronic renal failure New indication beraprost Japan/Asia Phase-III Oral Toray stimulator (primary, nephrosclerosis) New formulation sodium Depressive episode Japan Phase-III FK949E Serotonin/dopamine in bipolar disorders New indication Oral AstraZeneca quetiapine antagonist New formulation Major depressive disorder Japan Phase-II Irritable bowel syndrome Japan Phase-III New indication YM060 Female patients 5-HT3 receptor antagonist Oral In-house ramosetron Irritable bowel syndrome Japan New formulation (Orally-disintegrating tablet) Bioequivalent study ASP1585 Hyperphosphatemia (AMG223) Amine-functional polymer in patients not on dialysis Japan Phase-III Oral Ilypsa/Amgen New indication bixalomer with chronic kidney disease ASP3550 Prostate cancer GnRH antagonist Japan Phase-II Injection Ferring New formulation degarelix (Three-month formulation) ASP7373 Influenza vaccine Prophylaxis of H5N1 influenza Japan Phase-II Injection UMN Pharma ASP7374 Influenza vaccine Prophylaxis of seasonal influenza Japan Phase-II Injection UMN Pharma ASP0456 Guanylate cyclase type-C Irritable bowel syndrome Japan Phase-II Oral Ironwood linaclotide receptor agonist 26
  7. 7. 3. Local Development: Europe (1) Filed Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form Lower urinary tract symptoms EC905 Fixed dose combination of associated with benign prostatic Europe Filed solifenacin/ Oral In-house solifenacin and tamsulosin hyperplasia, with storage (Mar. 2012) tamsulosin symptoms (2) Phase-lll/ Phase-ll Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form NGX-4010 TRPV1 agonist Peripheral diabetic neuropathy Europe Phase-III Patch NeurogesX New indication capsaicin 27
  8. 8. 4. Phase-l Code No. Dosage Target Disease Origin Generic Name Form AGS-16M8F/ Cancer (ADC technology) Injection In-house (Agensys) AGS-16C3F In-house (Agensys) ASG-5ME Cancer (ADC technology) Injection (co-development with Seattle Genetics) ASP7035 Nocturia Oral In-house ASP0777 Alzheimer’s disease [Dementia] Oral In-house Lower urinary tract symptoms ASP0306 Oral In-house associated with benign prostatic hyperplasia ASP4058 Multiple sclerosis Oral In-house ASP4901 Lower urinary tract symptoms Oral ASKA (AKP-002) associated with benign prostatic hyperplasia ASP8477 Neuropathic pain Oral In-house ASP2408 Rheumatoid arthritis Injection In-house (Perseid) ASP3026 Cancer Oral In-house ASP9521 Prostate cancer Oral In-house In-house (Agensys) ASG-22ME Cancer (ADC technology) Injection (co-development with Seattle Genetics) ASP9226 Neuropathic pain Oral In-house ASP9603 Prostate cancer Oral In-house ASP7991 Secondary hyperparathyroidism Oral In-house ASP2409 Prevention of organ transplant rejection Injection In-house (Perseid) ASP6973 Osteoarthritis, Chronic low back pain Oral In-house Lower urinary tract symptoms ASP6432 Oral In-house associated with benign prostatic hyperplasia 28
  9. 9. 5. Project Discontinued Code No. Phase Target Disease Reason We have decided to discontinue the development ASP5034 Phase-I Type 2 diabetes after comprehensive review of phase-I study results and competitive situation etc. 29
  10. 10. <Changes from the Previous Announcement on May 10, 2012> Launched -Amoxicillin: Removed the previous item below for changes in the maximum pediatric dosages approved in February 2012. -ASP1585: Removed the previous item below. ASP1585 was launched in Japan in June 2012. -ASP8825: Removed the previous item below. ASP8825 was launched in Japan in July 2012. Code No. Product Name Dosage Classification Target Disease Area Origin Remarks Generic Name (Approval Date) Form Changes in the maximum Additional Sawacillin pediatric dosages for infections amoxicillin Penicillin antibiotic Japan Oral In-house dosage and (Feb. 2012) excluding helicobacter pylori administration infection ASP1585 Hyperphosphatemia Kiklin Amine-functional (AMG223) in patients on dialysis Japan Oral Ilypsa/Amgen (Mar. 2012) polymer bixalomer with chronic kidney disease ASP8825 (XP13512) Regnite Moderate-to-severe primary Prodrug of gabapentin Japan Oral XenoPort gabapentin (Jan. 2012) restless legs syndrome enacarbil -Fidaxomicin: Removed the previous item below. Fidaxomicin was launched in Europe in May 2012. Code No. Product Name Dosage Classification Target Disease Area Origin Remarks Generic Name (Approval Date) Form DIFICLIR Treatment of clostridium fidaxomicin Macrocyclic antibiotic Europe Oral Optimer (Dec. 2011) difficile infection Approved -YM178: Approved in the US in June 2012. Code No. Product Name Dosage Classification Target Disease Area Origin Remarks Generic Name (Approval Date) Form Overactive bladder associated with YM178 Myrbetriq symptoms of urgency, Beta 3 receptor agonist US Oral In-house mirabegron (Jun. 2012) urinary frequency, and urge urinary incontinence 30
  11. 11. -ASP3550: Approved in Japan in June 2012. Code No. Product Name Dosage Classification Target Disease Area Origin RemarksGeneric Name (Approval Date) Form ASP3550 Gonax Prostate cancer GnRH antagonist Japan Injection Ferring degarelix (Jun. 2012) (One-month formulation)Filed-MDV3100: Filed in the US and Europe for metastatic castration-resistant prostate cancer who have received docetaxel-based chemotherapy. (Changed underlined part) Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form US Filed Metastatic castration-resistant prostate (May 2012) cancer who have received Europe Filed docetaxel-based chemotherapy (Jun. 2012) MDV3100 Androgen receptor Japan Phase-II Oral Medivation enzalutamide* signaling inhibitor US Phase-III Prostate cancer Europe Phase-III New indication (Chemotherapy-naive etc.) Japan Phase-III Asia Phase-III Breast cancer US Phase-I New indication*p-INN (proposed international nonproprietary name)Phase-III/ Phase-II-Erlotinib: Deleted hepatocellular carcinoma from the target disease due to the discontinuation of the development. Added combination with MetMab in Non-small cell lung cancer, Colorectal carcinoma and Pediatric ependymoma to the target disease, for which phase-III studies are ongoing. (Changed underlined part) Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form Non-small cell lung cancer HER1/EGFR (First line for patients with EGFR mutation, erlotinib tyrosine kinase adjuvant, combination with MetMab), US Phase-III Oral In-house (OSI) New indication (Tarceva) inhibitor Hepatocellular carcinoma, Colorectal carcinoma, Pediatric ependymoma 31
  12. 12. -YM060: Entered into phase-III in Japan for irritable bowel syndrome in female patients. (Changed underlined part)-ASP1585: Entered into phase-III in Japan for hyperphosphatemia in patients not on dialysis with chronic kidney disease. Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form YM060 5-HT3 receptor Irritable bowel syndrome Japan Phase-III Oral In-house New indication ramosetron antagonist Female patients ASP1585 Amine-functional Hyperphosphatemia in patients not on (AMG223) Japan Phase-III Oral Ilypsa/Amgen New indication polymer dialysis with chronic kidney disease bixalomer-ASP1707: Entered into phase-II in Europe/Japan for endometriosis. (Changed underlined part) Code No. Dosage Classification Target Disease Area / Phase Origin Remarks Generic Name Form Europe/Japan Endometriosis Phase-II ASP1707 GnRH antagonist Oral In-house Prostate cancer Europe Phase-IPhase-I (Newly Developed)-ASP6432 [Lower urinary tract symptoms associated with benign prostatic hyperplasia]: Added to the phase-I list.Project Discontinued-ASP5034 [Type 2 diabetes]: Deleted from the list due to the development discontinueation.Deleted from the list-ASP7147 [Irritable bowel syndrome] in phase-I: Deleted from the list because we decided not to develop it by ourselves. The asset of ASP7147 was transferred to another company as a part of activities of "Multi-Track R&D". 32

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