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Optumrx Brand Pipeline Forecast

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Optumrx Brand Pipeline Forecast RxOutlook® 3rd Quarter 2017 OptumRx brand pipeline forecast Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug 2017 Possible launch date Travivo gepirone ER GSK/ Fabre-Kramer 5-HT-1A receptor agonist Major depressive disorder PO CRL n/a N N salmon calcitonin (TAR01- Tarsa/ Unigene Tbria osteoclast inhibitor Osteoporosis PO Filed NDA 2H2017 N N 201) Laboratories Ontinua ER arbaclofen extended-release Osmotica muscle relaxant Spasticity PO Filed NDA 2H2017 Y N GF-00100100 ozenoxacin Medimetriks/ Cipher quinolone (non-fluorinated) Bacterial infections TOP Filed NDA 3Q2017 N N methylphenidate modified- Attention deficit hyperactivity Benjorna Highland Therapeutics CNS stimulant PO Filed NDA 3Q2017 N N release disorder (ADHD) urate transporter1 and organic anion transporter 4 Duzallo lesinurad/ allopurinol AstraZeneca Gout PO Filed NDA 8/2017 N N inhibitor/ hypoxanthine analog anti-CD22 antibody-drug Acute myeloid leukemia Besponsa inotuzumab ozogamicin Pfizer/ UCB IV Filed NDA 8/20/2017 Y Y conjugate (AML) carbapenem/ beta- Carbavance meropenem/ vaborbactam Medicines Company Bacterial infections IV Filed NDA 8/20/2017 N N lactamase inhibitor Dyskinesia in Parkinson's Nurelin amantadine ER Adamas antiviral PO Filed NDA 8/24/2017 N Y disease/ Multiple sclerosis anti-rabies immunoglobulin KamRAB Kamada/ Kedrion immune globulin Rabies IM Filed BLA 8/29/2017 Y N (human) interleukin-6 (IL-6) Plivensia sirukumab Janssen / GSK Rheumatoid arthritis SC Filed BLA 9/2017 Y N monoclonal antibody optum.com/optumrx 1 RxOutlook® 3rd Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug angiotensin receptor blocker EZR-104 valsartan controlled-release Ezra Innovations Heart failure/ Hypertension PO Filed NDA 9/10/2017 N N (ARB) amphetamine XR- amphetamine extended- Attention deficit hyperactivity Neos Therapeutics stimulant PO Filed NDA 9/17/2017 N N liquid release disorder (ADHD) Solosec secnidazole Symbiomix 5-nitroimidazole antibiotic Urinary tract infection PO Filed NDA 9/17/2017 N N phosphodiesterase-5 (PDE- tadalafil pharmafilm tadalafil pharmafilm MonoSol Rx Erectile dysfunction PO Filed NDA 9/18/2017 Y N 5) inhibitor ITCA-650 (sustained Intarcia/ Quintiles/ glucagon-like peptide-1 exenatide sustained-release Diabetes mellitus SC implant Filed NDA 9/21/2017 Y N release exenatide) Servier (GLP-1) receptor agonist Rexista XR oxycodone ER Intellipharmaceutics opioid agonist Pain PO Filed NDA 9/25/2017 N N antibody-drug conjugate (CD-33 Ab linked to Acute myeloid leukemia Mylotarg gemtuzumab ozogamicin Pfizer IV Filed BLA 9/30/2017 Y Y calicheamicin, a cytotoxic (AML) agent) insulin aspart (ultra fast FIAsp Novo Nordisk fast-acting insulin Diabetes mellitus SC CRL 9/30/2017 N N acting) pregabalin controlled- Postherpetic neuralgia Lyrica CR Pfizer GABA structural analogue PO Filed sNDA 10/2/2017 N N release (PHN)/ Fibromyalgia Acute lymphoblastic leukemia (ALL)/ Diffuse chimeric antigen receptor CTL-019 tisagenlecleucel Novartis large B-cell lymphoma IV Filed BLA 10/3/2017 Y Y (CAR) T cell therapy (DLBCL)/ Chronic lymphocytic leukemia (CLL) Zilretta triamcinolone acetonide Flexion corticosteroid Osteoarthritis Intra-articular Filed NDA 10/6/2017 Y N ARX-04 sufentanil AcelRx opioid analgesic Pain SL Filed NDA 10/12/2017 Y N Vibex QST (QuickShot testosterone Antares androgen Hypogonadism SC Filed NDA 10/20/2017 N N Testosterone) recombinant human Factor LR-769 eptacog beta LFB SA Hemophilia IV Filed BLA 10/23/2017 Y N VIIa optum.com/optumrx 2 RxOutlook® 3rd Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Duchenne muscular dystrophy/ Translarna ataluren PTC Therapeutics gene transcription modulator PO Filed NDA 10/24/2017 Y Y Mucopolysaccharidosis (MPS) neurokinin-1 (NK-1) receptor Varubi rolapitant Tesaro/Opko Health Nausea and vomiting (N/V) IV Filed NDA 10/25/2017 Y N antagonist folate analog metabolic Non-small cell lung cancer EP-5101 pemetrexed Eagle Pharmaceuticals IV Filed NDA 10/30/2017 Y N inhibitor (NSCLC)/ Mesothelioma neurokinin-1 (NK1) receptor Cinvanti aprepitant Heron Therapeutics Nausea and vomiting (N/V) IV Filed NDA 11/12/2017 N N antagonist beta-glucuronidase Mucopolysaccharidosis VII UX-003 (rhGUS) Ultragenyx enzyme replacement IV Filed BLA 11/16/2017 Y Y (recombinant) (MPS-VII) Non-Hodgkin's lymphoma phosphatidylinositol-3 kinase BAY-80-6946 copanlisib Bayer (NHL)/ Diffuse large B-cell IV/PO Filed NDA 11/17/2017 Y Y (PI3K) inhibitor lymphoma inhaled corticosteroid (ICS)/ fluticasone furoate/ fluticasone furoate/ long-acting muscarinic agent Chronic obstructive umeclidinium/ GSK/ Innoviva INH Filed NDA 11/21/2017 N N umeclidinium/ vilanterol (LAMA)/ long-acting beta pulmonary disease (COPD) vilanterol agonist (LABA) Otsuka/ Proteus Digital Schizophrenia/ Bipolar/ Abilify aripiprazole atypical antipsychotic PO Filed NDA 11/23/2017 N N Health Major Depression AstraZeneca/ Alkermes/ glucagon-like peptide-1 Bydureon exenatide Bristol-Myers Squibb/ Eli Diabetes mellitus SC Filed sNDA 11/27/2017 N N (GLP-1) receptor agonist Lilly Non-Hodgkin lymphoma/ Mantle cell lymphoma/ Diffuse Large B-Cell chimeric antigen receptor CAR-T ciloleucel axicabtagene ciloleucel Kite Lymphoma (DLBCL)/ IV Filed NDA 11/29/2017 Y Y (CAR) T cell therapy Chronic lymphocytic leukemia (CLL)/ Small cell lymphocytic lymphoma (SLL) opioid receptor agonist RBP-6000 buprenorphine depot Indivior/ QLT Drug addiction SC Filed NDA 11/30/2017 Y N (partial) optum.com/optumrx 3 RxOutlook® 3rd Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug sodium zirconium ZS-9 ZS Pharma potassium-binding agent Hyperkalemia PO CRL 4Q2017 N N cyclosilicate cyclosporine A (Nova- Dry eye/ Vernal Cyclokat Santan SAS immunosuppressant TOP InTrial 4Q2017 Y Y 22007) keratoconjunctivitis Apealea (Paclical) paclitaxel Oasmia taxane Ovarian cancer IV InTrial 4Q2017 Y Y FastTrk/ Prostvac rilimogene glafolivec BN ImmunoTherapeutics vaccine Prostate cancer SC 4Q2017 Y N Breakthru Diffuse large B-cell lymphoma (DLBCL)/ Pixuvri pixantrone Cell Therapeutics anthracycline derivative IV CRL 4Q2017 Y N Follicular lymphoma/ Non- Hodgkin's lymphoma (NHL) Pancreatic islet reparixin reparixin Dompe interleukin-8 (IL-8) inhibitor IV InTrial 4Q2017 Y Y transplantation FastTrk/ Civacir hepatitis C immunoglobulin Biotest immunoglobulin Hepatitis C (HCV) IV 4Q2017 Y Y Breakthru DCVax-L, DCVax- glioblastoma multiforme Northwest vaccine Glioblastoma SC InTrial 4Q2017 Y Y Brain vaccine Biotherapeutics Non-small cell lung cancer tertomotide tertomotide KAEL-GemVax vaccine Intradermal InTrial 4Q2017 Y N (NSCLC)/ Melanoma RNA polymerase inhibitor/ rifabutin/ amoxicillin/ RHB-105 RedHill Biopharma penicillin/ proton pump Bacterial infections PO InTrial 4Q2017 N N pantoprazole inhibitor (PPI) Primary immunodeficiency/ RI-002 RI-002 ADMA Biologics immunoglobulin Respiratory syncytial virus/ IV CRL 4Q2017 Y N Bacterial infections ABX-203 ABX-203 Abivax vaccine Hepatitis B (HBV) SC/ intranasal InTrial 4Q2017 N N amantadine extended- Osmolex ER (OS-320) Osmotica antiviral Dyskinesia PO InTrial 4Q2017 N Y release Medicines Development MDL moxidectin chloride channel agonist Parasitic infections PO InTrial 4Q2017 N N for Global Health Aeroquin levofloxacin HCl Raptor fluoroquinolone Cystic fibrosis (CF) INH InTrial 4Q2017 Y Y optum.com/optumrx 4 RxOutlook® 3rd Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug vascular endothelial growth Ovarian cancer/ Biliary tract Recentin cediranib AstraZeneca factor receptor (VEGF) PO InTrial 4Q2017 Y Y cancer antagonists FMX-102 (FXFM-244) minocycline Foamix tetracyclines Impetigo TOP InTrial 4Q2017 N N Shingrix (GSK- herpes zoster vaccine GSK vaccine Herpes zoster IM Filed BLA 4Q2017 Y N 1437173A) aspartyl-alanyl Ampion Ampio Pharmaceuticals immunomodulator Osteoarthritis Intra-articular InTrial Late 2017 Y N diketopiperazine (DA-DKP) human plasminogen human plasminogen Kedrion plasminogen Plasminogen deficiency TOP InTrial Late 2017 Y Y ELI-202 opioid (undisclosed) Elite opioid agonist Pain PO InTrial Late 2017 N N Healthpoint allogeneic neonatal HP802-247 HP802-247 Venous leg ulcer TOP InTrial Late 2017 Y N Biotherapeutics keratinocytes and fibroblasts growth hormone Anorexia/ Cachexia (cancer- FastTrk/ anamorelin anamorelin Helsinn / Novo Nordisk secretagogue receptor PO Late 2017 Y N related) Breakthru (GHSR) agonist lubiprostone lubiprostone Takeda/ Sucampo chloride channel activator Constipation PO InTrial Late 2017 N N janus associated kinase Myeloproliferative disorders/ CYT-387 momelotinib Gilead PO InTrial Late 2017 Y Y (JAK) inhibitor Pancreatic cancer CEM-101 solithromycin Cempra macrolide Bacterial infections IV/PO CRL Late 2017 N N FastTrk/ midazolam (USL-261) midazolam (USL-261) Upsher-Smith benzodiazepine Seizures Intranasal Late 2017 N Y Breakthru FLT-3 receptor tyrosine Acute myeloid leukemia quizartinib quizartinib Ambit Biosciences PO InTrial Late 2017 Y N kinase inhibitor (AML) pegylated arginine Hepacid ADI-PEG-20 Polaris Hepatic cancer IM InTrial Late 2017 Y Y deiminase Portola/ Pfizer/ Bristol- recombinant Factor Xa
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