R&D Pipeline (As of Jul 2018) Underlined items indicate changes from the previous announcement on Apr 26, 2018.
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1 R&D Pipeline (As of Jul 2018) Underlined items indicate changes from the previous announcement on Apr 26, Oncology (1/2) MDV3100 enzalutamide (XTANDI ) Androgen receptor inhibitor Non-metastatic castration-resistant prostate cancer Non-metastatic hormone-sensitive prostate cancer Approved (Jul. 2018) / US Filed (Jan. 2018) / Europe P-III / US, Europe, Asia Pfizer Metastatic hormone-sensitive prostate cancer 31 ASP3550 degarelix (GONAX ) AMG 103 blinatumomab ASP2215 gilteritinib GnRH antagonist Prostate cancer (3-month formulation) Filed (Nov. 2017) / Japan Injection Ferring Anti-CD19 BiTE antibody Acute lymphoblastic leukemia Filed (Jan. 2018) / Japan Injection Amgen with Amgen Astellas) FLT3/AXL inhibitor Relapsed or refractory acute myeloid leukemia Post-chemo maintenance acute myeloid leukemia Filed (Mar. 2018) / US, Japan P-III / Europe, Asia In-house Post-HSCT maintenance acute myeloid leukemia Newly diagnosed acute myeloid leukemia with low intensity induction of chemotherapy Newly diagnosed acute myeloid leukemia with high intensity induction of chemotherapy P-II/III / US, Europe, Japan, Asia P-I / US, Japan IMAB362 zolbetuximab ASG-22ME enfortumab vedotin Anti-Claudin 18.2 Gastric and gastroesophageal junction adenocarcinoma Injection In-house (Ganymed) ADC targeting nectin-4 Urothelial cancer Injection In-house with Seattle Genetics) AGS-16C3F ADC targeting ENPP3 Renal cell carcinoma, Europe Injection In-house (ADC technology in-licensed from Seattle Genetics) AGS67E Lymphoid malignancies P-I Injection In-house (ADC technology in-licensed from Seattle Genetics)
2 Oncology (2/2) AGS62P1 Acute myeloid leukemia P-I Injection In-house (ADC technology, EuCODE license from Ambrx) ASP8374/PTZ-201 Cancer P-I Injection Option agreement with Potenza Biology: Cancer Immunology ASP1948/PTZ-329 Cancer P-I Injection Option agreement with Potenza Biology: Cancer Immunology Updates from the previous announcement (Apr. 2018): MDV3100 (enzalutamide): Approved in US for non-metastatic castration-resistant prostate cancer in Jul ASP1948/PTZ-329: Initiated clinical development for cancer. 32
3 Immunology, Muscle disease and Ophthalmology FK506 tacrolimus Immunosuppressant Prevention of rejection after organ transplantation (Granule formulation in pediatric use) Approved (May 2018) / US In-house ASP015K peficitinib JAK inhibitor Rheumatoid arthritis Filed (May 2018) / Japan In-house ASKP1240 bleselumab Anti-CD40 Recurrence of focal segmental glomerulosclerosis in de novo kidney transplant recipients Injection Kyowa Hakko Kirin ASP4070/ JRC2-LAMP-vax DNA vaccine for Japanese red cedar Pollinosis caused by Japanese red cedar P-II / Japan Injection Immunomic LAMP-vax technology ASP5094 Anti-alpha-9 integrin Rheumatoid arthritis P-II / Japan Injection In-house CK reldesemtiv Fast skeletal troponin activator Spinal muscular atrophy Cytokinetics Biology: Molecular motor Chronic obstructive pulmonary disease 33 Amyotrophic lateral sclerosis ASP7317 Cell therapy (Retinal pigment epithelium cell) Dry age-related macular degeneration, Stargardt s macular degeneration Injection In-house (Astellas Institute for Regenerative Medicine) MA-0211 Duchenne muscular dystrophy P-I In-house (Mitobridge) ASP0892 Peanut allergy P-I Injection Immunomic Cell therapy Biology: Mitochondria LAMP-vax technology Update from the previous announcement (Apr. 2018): FK506 (tacrolimus): Approved in US for prevention of rejection after organ transplantation (granule formulation in pediatric use) in May ASP015K (peficitinib): Filed in Japan for rheumatoid arthiritis in May 2018.
4 Urology and Nephrology EB178 solifenacin/ mirabegron YM905 solifenacin Combination therapy of solifenacin and mirabegron Muscarine M 3 receptor antagonist Overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency Neurogenic detrusor overactivity in pediatric patients Approved (Apr. 2018) / US In-house Filed (Feb. 2017) / US In-house Focus Area Approach ASP1517/FG-4592 roxadustat HIF stabilizer Anemia associated with chronic kidney disease in patients not on dialysis and on dialysis P-III / Europe P-III / Japan FibroGen YM178 mirabegron Beta 3 receptor agonist Neurogenic detrusor overactivity in pediatric patients P-III / Europe In-house YM311/FG-2216 HIF stabilizer Renal anemia P-II / Europe P-I / Japan FibroGen 34 ASP6294 ASP8302 Nerve Growth Factor (NGF) neutralization antibody Muscarine M 3 receptor positive allosteric modulator Bladder pain syndrome / Interstitial cystitis P-II / Europe Injection In-house Underactive bladder P-II / Europe, Japan In-house ASP7713 Underactive bladder P-I In-house MA-0217 Acute kidney injury P-I Injection In-house (Mitobridge) Biology: Mitochondria Update from the previous announcement (Apr. 2018): EB178 (solifenacin/mirabegron): Approved in US for the combination use of solifenacin and mirabegron in over active bladder patients obtained in Apr ASP8232: Discotinued Phase 2 program for diabetic kidney disease due to strategic prioritization.
5 Others fidaxomicin Macrocyclic antibiotic Infectious enteritis Approved (Jul. 2018) / Japan Merck (bacterial target: Clostridium difficile ) Clostridium difficile infection in pediatric patients P-III / Europe 35 AMG 785 romosozumab ASP1941 ipragliflozin (Suglat ) ASP0456 linaclotide (LINZESS ) ESN364 fezolinetant ASP0819 Anti-Sclerostin Osteoporosis for those at high risk of fracture Filed (Dec. 2016) / Japan Injection Amgen with Amgen Astellas) SGLT2 inhibitor Type 1 diabetes Filed (Jan. 2018) / Japan In-house with Kotobuki) Guanylate cyclase-c receptor agonist Chronic constipation Filed (Sep. 2017) / Japan Ironwood NK3 receptor antagonist Menopause-related vasomotor symptoms P-I / Japan Calcium2+-activated K+ channel opener In-house (Ogeda) Fibromyalgia In-house ASP4345 Dopamine D 1 receptor positive allosteric modulator Cognitive impairment associated with schizophrenia In-house ASP1807/CC8464 Neuropathic pain P-I Chromocell ASP6981 Cognitive impairment associated with schizophrenia P-I In-house MucoRice-CTB Prophylaxis of diarrhea caused by Vibrio cholerae P-I The Institute of Medical Science, the University of Tokyo Updates from the previous announcement (Apr. 2018): fidaxomicin (Dafclir ): Approved in Japan for infectious enteritis (bacterial target: Clostridium difficile ) in Jul ASP8062: Discontinued Phase 2 program for fibromyalgia because Phase 2 study did not meet its primary endpoint. MucoRice-CTB: Initiated clinical development for prophylaxis of diarrhea caused by Vibrio cholerae.
*Compounds with "In-house" in this column include ones discovered by collaborative research.
AGS67E Lymphoid malignancies P-I Injection In-house (ADC technology in-licensed from Seattle Genetics) AGS62P1 Acute myeloid leukemia P-I Injection In-house (ADC technology, EuCODE license from Ambrx)
R&D Pipeline (As of Apr 2018) Underlined items indicate changes from the previous announcement on Jan 31, 2018.
R&D Pipeline (As of Apr 2018) Underlined items indicate changes from the previous announcement on Jan 31, 2018. Oncology (1/2) MDV3100 enzalutamide Androgen receptor inhibitor Castration-resistant prostate
R&D Pipeline (As of Oct 2018) Underlined items indicate changes from the previous announcement on July 27, 2018.
R&D Pipeline (As of Oct 2018) Underlined items indicate changes from the previous announcement on July 27, 2018. Oncology (1/2) enzalutamide MDV3100 (XTANDI ) Androgen receptor inhibitor Non-metastatic
R&D Pipeline (As of April 2017)
R&D Pipeline (As of April 2017) Underlined items indicate changes from the previous announcement on January 31, 2017. Oncology (1/2) MDV3100 enzalutamide Androgen receptor inhibitor Metastatic castration-resistant
R&D Pipeline (As of July 2016) 1. Global Development Underlined items indicate for changes from the previous announcement on May 11, (1) Regulat
R&D Pipeline (As of July 2016) 1. Global Development Underlined items indicate for changes from the previous announcement on May 11, 2016. (1) Regulatory decision *Compounds with "" in this column include
R&D Pipeline (May 2014) 1. Global Development (1) Approved Product Name (Approval Date) Classification Target Disease Area * MDV3100 enzalutamide XTAN
R&D Pipeline (May 2014) 1. Global Development (1) Approved Product Name (Approval Date) Classification Target Disease Area * MDV3100 enzalutamide XTANDI (Mar. 2014) Androgen receptor inhibitor
(2) Phase-lll / Phase-ll (2/3) ASP7487 (OSI-906) linsitinib IGF-1R/IR tyrosine kinase inhibitor Adrenocortical carcinoma Ovarian cancer, Non-small cel
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
(3) Phase-lll / Phase-ll (1/3) Stage in the most advanced territory EC905 solifenacin/ tamsulosin Concomitant use of solifenacin and tamsulosin Lower
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
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MEDICAL POLICY SUBJECT: PERCUTANEOUS POSTERIOR TIBIAL NERVE STIMULATION (PPTNS) POLICY NUMBER: CATEGORY: Technology Assessment
MEDICAL POLICY SUBJECT: PERCUTANEOUS POSTERIOR Clinical criteria used to make utilization review decisions are based on credible scientific evidence published in peer reviewed medical literature generally