Sumitomo Dainippon Pharma Annual Report 2017

Development PipelineBrand name /Product codeGeneric nameProposed indicationDevelopment locationPhase 1SubmittedPhase 3Phase 2*1(As of July 28, 2017)*1 A Phase 2/3 study completed, development strategy under considerationAPTIOM®eslicarbazepine acetateLONASEN®blonanserinEPI-743vatiquinoneSEP-225289dasotralineAPL-130277apomorphine hydrochlorideTRERIEF®zonisamideEPI-589TBDSEP-363856TBDDSP-2230TBDDSP-1200TBDDSP-6745TBDSEP-378608TBDLATUDA®(SM-13496)lurasidone hydrochloride(New indication) Epilepsy- Monotherapy(New usage :pediatric) Epilepsy- Monotherapy / adjunctive therapySchizophrenia(New usage :pediatric) Bipolar I depressionSchizophreniaBipolar I depression, Bipolar maintenance(New usage :pediatric) Schizophrenia(New formulation: Transdermal patch) SchizophreniaLeigh syndromeAdult, Pediatric attention-deficit hyperactivity disorder (ADHD)Binge eating disorder (BED)OFF episodes associated with Parkinson’s disease(New indication) Parkinsonism in Dementia with Lewy Bodies (DLB)Parkinson’s diseaseAmyotrophic lateral sclerosis (ALS)SchizophreniaParkinson’s disease psychosisSchizophreniaNeuropathic painTreatment-resistant depressionParkinson’s disease psychosisBipolar disorderCanadaU.S.ChinaU.S. / CanadaJapanJapanJapanJapanJapanU.S.U.S.U.S.JapanU.S.U.S.U.S.U.S.JapanU.K. / U.S. / JapanU.S.U.S.U.S.Research & DevelopmentDasotraline (SEP-225289)In the U.S., a Phase 2/3 study and Phase 3 study were conducted evaluating the drug in pediatric attention-deficit hyperactivity disorder (ADHD). The studies met their primary endpoints. Based on the results of these studies and prior adult studies, we intend to submit a New Drug Application in the U.S. in fiscal 2017 for ADHD in adult and pediatric populations.Dasotraline also met the primary endpoint of a Phase 2/3 study for binge eating disorder (BED) and we have started a Phase 3 study. We will continue to develop dasotraline for BED in adults in the U.S. TRERIEF®In order to obtain approval for a new indication of TRERIEF® in Japan, a Phase 3 study was conducted evaluating its effects in patients with Parkinsonism in dementia with Lewy bodies. The study produced encouraging analytical results.Based on these results, we intend to submit a supplemental New Drug Application for the new indication in Japan in fiscal 2017.Apomorphine hydrochloride (APL-130277)Currently undergoing a Phase 3 study on OFF episodes associated with Parkinson’s disease in the U.S. We are aiming to submit a New Drug Application in the U.S. in fiscal 2017.Psychiatry & Neurology Area23Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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