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Brand Pipeline Forecast 4Th Quarter 2019 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug 2019 Possible Launch Date RVT-802 RVT-802 Enzyvant/Roivant Tissue-based therapy Congenital athymia Implant Filed NDA 12/2019 Yes Yes Zimhi naloxone Adamis opioid antagonist Opioid dependence IM Filed NDA 12/2019 No No calcitonin gene-related MK-1602 (AGN-241689) ubrogepant Allergan/ Merck peptide (CGRP) receptor Acute migraines PO Filed NDA 12/2019 No No antagonist IDP-123 IDP-123 Bausch Health retinoid Acne TOP Filed NDA 12/22/2019 No No Brinavess vernakalant Correvio potassium channel blocker Arrhythmia IV Filed NDA 12/24/2019 Yes No E-2006 lemborexant Eisai/ Purdue orexin receptor antagonist Insomnia PO Filed NDA 12/27/2019 No No ITI-007 lumateperone Intra-Cellular Therapies antipsychotic Schizophrenia PO Filed NDA 12/27/2019 No No HIV integrase inhibitor/ cabotegravir (long-acting)/ non-nucleoside reverse TMC-278-LA ViiV Healthcare HIV IM Filed NDA 12/29/2019 Yes No rilpivirine (long- acting) transcriptase inhibitor (NNRTI) S-265744 (S/GSK- 1265744) cabotegravir ViiV Healthcare HIV integrase inhibitor HIV PO Filed NDA 12/29/2019 Yes No NRL-1 diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 2H2019 No Yes 2020 Possible Launch Date integrin receptor 12/2019 - Entyvio (SC formulation) vedolizumab Takeda Ulcerative colitis SC Filed sBLA Yes No antagonist 1/2020 methyltransferase EZH2 E-7438 (EPZ- 6438) tazemetostat Epizyme/ Eisai Sarcoma PO Filed NDA 1/23/2020 Yes Yes inhibitor CastiaRx.com // p: 866.516.2121 1 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug Schizophrenia/ Rykindo risperidone ER Luye atypical antipsychotic IM Filed NDA 1/28/2020 Yes No Schizoaffective disorder gonadotropin-releasing FP-001 (LMIS) leuprolide mesylate Foresee Prostate cancer SC Filed NDA 1/29/2020 Yes No hormone (GnRH) analog AR-101 AR-101 Aimmune peanut protein capsule Peanut allergy PO Filed BLA 1/2020 Yes No selective KIT and PDGFRa Gastrointestinal stromal BLU-285 avapritinib Blueprint Medicines PO Filed NDA 2/14/2020 Yes Yes inhibitor tumors ethinyl estradiol/ hormonal combination Twirla Agile Therapeutics Pregnancy prevention TOP Filed NDA 2/16/2020 No No levonorgestrel contraceptive calcitonin gene-related BMS-927711 (BHV-3000) rimegepant sulfate Biohaven peptide (CGRP) receptor Acute migraines PO Filed NDA 2/20/2020 No No antagonist calcitonin gene-related ALD-403 eptinezumab Alder peptide (CGRP) receptor Migraine prevention IV Filed BLA 2/21/2020 No No antagonist ETC-1002 bempedoic acid Esperion Therapeutics ATP citrate lyase inhibitor Hypercholesterolemia PO Filed NDA 2/21/2020 No No ATP citrate lyase inhibitor/ ETC-1002/ bempedoic acid/ ezetimibe Esperion Therapeutics cholesterol absorption Hypercholesterolemia PO Filed NDA 2/26/2020 No No ezetimibe inhibitor dopamine receptor APD-421 amisulpride Acacia Nausea/ vomiting IV Filed NDA 2/26/2020 No No antagonist insulin-like growth factor 1 RV-001 (Roche- 1, R-1507) teprotumumab Horizon Therapeutics Thyroid eye disease IV Filed BLA 3/8/2020 Yes Yes (IGF-1) receptor antagonist ITCA-650 exenatide sustained- glucagon-like peptide-1 (sustained release Intarcia Diabetes mellitus SC implant Filed NDA 3/9/2020 No No release (GLP-1) receptor agonist exenatide) VS-EBOV (rVSV- EBOV; rVSV- ZEBOV Merck/ NewLink Genetics vaccine Ebola IM Filed BLA 3/14/2020 Yes No ZEBOV-GP) CastiaRx.com // p: 866.516.2121 2 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug naloxone naloxone Insys Therapeutics opioid antagonist Opioid dependence Intranasal Filed NDA 3/15/2020 No No ASG-22M6E enfortumab vedotin Astellas/ Seattle Genetics nectin-4 antagonist Bladder cancer IV Filed BLA 3/15/2020 Yes No ET-105 lamotrigine Eton anticonvulsant Epilepsy PO Filed NDA 3/17/2020 No No sphingosine 1-phosphate 1 ozanimod ozanimod Celgene (S1PR1) and 5 (S1PR5) Multiple sclerosis PO Filed NDA 3/25/2020 Yes No receptor modulator farnesoid X receptor (FXR) Nonalcoholic obeticholic acid obeticholic acid Intercept Pharmaceuticals PO Filed NDA 3/26/2020 Yes No agonist steatohepatitis IntelGenx / Red Hill Rizaport (VersaFilm) rizatriptan triptans Acute migraines PO Filed NDA 3/26/2020 No No Biopharma anesthetic/ Nonsteroidal HTX-011 bupivacaine/ meloxicam Heron Therapeutics Anti-inflammatory Drug Pain Instillation Filed NDA 3/26/2020 No No (NSAID) Sun Pharma Advanced paclitaxel injection Breast Cancer; Lung SPARC-1028 Research Company taxane IV Filed NDA 1Q2020 No No concentrate for suspension Cancer; Pancreatic Cancer (SPARC) SABER- Posidur Novartis/ Durect local anesthetic Pain SC Filed NDA 1Q2020 No No bupivacaine CR aldosterone synthase LCI-699 osilodrostat Novartis Cushing's syndrome PO Filed NDA 1Q2020 No Yes inhibitor sodium glucose co- transporter-2 (SGLT-2) empagliflozin, linagliptin, empagliflozin, linagliptin, Eli Lilly/ Boehringer inhibitor, dipeptidyl Diabetes mellitus PO Filed NDA 1Q2020 No No metformin XR metformin XR Ingelheim peptidase 4 (DPP4) inhibitor, biguanide bimatoprost sustained bimatoprost sustained Allergan prostaglandin agonist Glaucoma Implant Filed NDA 4/1/2020 No No release release CNS-7056 remimazolam Cosmo benzodiazepine Procedural sedation IV Filed NDA 4/3/2020 Yes No CastiaRx.com // p: 866.516.2121 3 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug meningococcal polysaccharide (serogroups Men Quad TT Sanofi antibacterial meninococcus/ tetanus IM Filed BLA 4/25/2020 No No A, C, Y, and W135) tetanus toxoid conjugate vaccine catechol-O- Neurocrine Biosciences/ Ongentys opicapone methyltransferase (COMT) Parkinson's disease PO Filed NDA 4/26/2020 No No Bial/ Ono inhibitor Pulmonary arterial Trevyent treprostinil SteadyMed prostacyclin analog SC Filed NDA 4/27/2020 Yes Yes hypertension HER2-targeting antibody- DS-8201 trastuzumab deruxtecan Daiichi Sankyo Breast cancer IV Filed BLA 4/29/2020 Yes No drug conjugate Multiple myeloma/ Acute isatuximab isatuximab Sanofi/ ImmunoGen CD38 antagonist lymphoblastic leukemia or IV Filed BLA 4/30/2020 Yes Yes lymphoblastic lymphoma selective MEK kinase 4/2020 – selumetinib selumetinib AstraZeneca/ Merck Neurofibromatosis PO Filed NDA Yes Yes inhibitor 5/2020 SEP-225289 (DSP-225289, Sumitomo Dainippon/ dasotraline triple reuptake inhibitor Eating disorders PO Filed NDA 5/14/2020 No No SEP-289) Sunovion selective FGFR1/2/3 INCB-54828 pemigatinib Incyte Biliary tract cancer PO Filed NDA 5/2020 Yes Yes inhibitor FMX-103 minocycline Foamix tetracyclines Rosacea TOP Filed NDA 6/2/2020 No No morpholino antisense Duchenne muscular NS-065 viltolarsen Nippon Shinyaku IV Filed BLA 6/2/2020 Yes Yes oligonucleotide dystrophy Tentative Bafiertam monomethyl fumarate Banner Life Sciences Nrf2 pathway activator Multiple sclerosis PO 6/20/2020 Yes No Approval Age-related macular 6/2020 – abicipar pegol abicipar pegol Allergan VEGF-A inhibitor Intravitreal Filed BLA Yes No degeneration 7/2020 Neuromyelitis optica 6/13/2020 - MEDI-551 inebilizumab Viela Bio CD-19 antagonist IV Filed BLA Yes Yes spectrum disorder 7/13/2020 CastiaRx.com // p: 866.516.2121 4 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug EVK-001 metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal CRL 2Q2020 No No osmotic gradient enhancer; Bronchitol mannitol Pharmaxis Cystic fibrosis INH CRL 2Q2020 No Yes mucus clearance enhancer Rexista XR oxycodone ER IntelliPharmaCeutics opioid agonist Pain PO Not Approved 1H2020 No No insulin glargine insulin glargine Mylan/ Biocon Long-acting insulin Diabetes mellitus SC CRL 1H2020 No No RS7-SN-38 antibody-drug IMMU-132 sacituzumab govitecan Immunomedics Breast cancer IV CRL 1H2020 Yes No conjugate NKTR-181 NKTR-181 Nektar opioid agonist Pain PO Not Approved 1H2020 No No morpholino antisense Duchenne muscular SRP-4045 casimersen Sarepta IV InTrial Mid-2020 Yes Yes oligonucleotide dystrophy Contepo fosfomycin Nabriva Therapeutics cell wall inhibitor Bacterial infections IV CRL Mid-2020 Yes No RG-7916 risdiplam Roche/ PTC Therapeutics SMN2 splicing modifier Spinal muscular atrophy PO InTrial Mid-2020 Yes Yes Apealea (Paclical) paclitaxel Oasmia taxane Ovarian cancer IV InTrial Mid-2020 Yes Yes Diffuse large B-cell phosphoinositide-3 kinase TGR-1202 umbralisib TG Therapeutics/ Rhizen lymphoma/ Chronic PO InTrial Mid-2020 Yes Yes (PI3K) delta inhibitor lymphocytic leukemia Mesoblast/ JCR/ Prochymal remestemcel-L Mallinckrodt/ Osiris mesenchymal stem cells Graft vs. Host disease IV InTrial Mid-2020 Yes Yes Therapeutics MOR-208 (MOR-00208, Diffuse large B-cell tafasitamab MorphoSys/ Xencor CD-19 antagonist IV InTrial Mid-2020 Yes Yes XmAB-5574) lymphoma CastiaRx.com // p: 866.516.2121 5 Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug Solid tumors; non- small LOXO-292 selpercatinib Eli Lilly/ Loxo Oncology RET inhibitor cell lung cancer; thyroid PO InTrial
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