RxOutlook® 4th Quarter 2018 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 2018 Possible launch date Zemcolo DNA-dependent RNA rifamycin Cosmo/ Dr. Falk Traveler's diarrhea PO Filed NDA 11/16/2018 N N (Aemcolo) polymerase inhibitor MNK-812 oxycodone Mallinckrodt opioid agonist Pain PO Filed NDA 11/16/2018 N N interferon-gamma Primary hemophagocytic NI-0501 emapalumab NovImmune SA IV Filed BLA 11/20/2018 Y Y antagonist lymphohistiocytosis Loxo Oncology/ LOXO-101 larotrectinib tyrosine kinase inhibitor Solid tumors/ Sarcoma PO Filed NDA 11/26/2018 Y Y Bayer Lambert-Eaton amifampridine potassium channel Firdapse BioMarin/ Catalyst myasthenic syndrome PO Filed NDA 11/28/2018 Y Y phosphate blocker (LEMS) Acute myelogenous ASP-2215 gilteritinib fumarate Astellas tyrosine kinase inhibitor PO Filed NDA 11/29/2018 Y Y leukemia bupivacaine XaraColl Innocoll sodium channel blocker Pain implant Filed NDA 12/2/2018 Y N implant gamma aminobutyric allopregnanolone acid-A (GABA-A) Postpartum depression/ SAGE-547 SAGE/ Ligand IV Filed NDA 12/19/2018 Y Y (brexanolone) receptor allosteric Seizures modulator optum.com/optumrx 1 RxOutlook® 4th Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug ADX-N05 Jazz (ARL-N05, solriamfetol Pharmaceuticals/ phenylalanine derivative Narcolepsy/ Sleep apnea PO Filed NDA 12/20/2018 N Y JZP-110, SKL- Aerial BioPharma N05) SHP-555 prucalopride Shire 5-HT-4 receptor agonist Chronic constipation PO Filed NDA 12/21/2018 N N Acute lymphocytic EZN-2285 calaspargase pegol Shire enzyme therapy IM/IV Filed BLA 12/22/2018 Y N leukemia (ALL) Camurus/ opioid receptor agonist CAM-2038 buprenorphine Opioid dependence/ Pain SC Filed NDA 12/26/2018 Y N Braeburn (partial) dexamethasone Ocular Pain/ Allergic Dextenza corticosteroid implant Filed NDA 12/28/2018 N N sustained-release Therapeutix conjunctivitis Acute myeloid leukemia Cyclacel / Daiichi sapacitabine sapacitabine antimetabolite (AML)/ Non-small cell PO InTrial Late 2018 Y Y Sankyo lung cancer (NSCLC) growth hormone Helsinn / Novo Anorexia/ Cachexia FastTrk/ Adlumiz anamorelin secretagogue receptor PO Late 2018 Y N Nordisk (cancer-related) Breakthru (GHSR) agonist brincidofovir Adenovirus/ DNA-directed DNA FastTrk/ CMX-001 hexadecyloxypropy Chimerix Cytomegalovirus (CMV)/ PO Late 2018 N Y polymerase inhibitor Breakthru l ester Smallpox CEM-101 solithromycin Cempra macrolide Bacterial infections IV/PO CRL Late 2018 N N FastTrk/ BAY-41-6551 amikacin Nektar/ Bayer aminoglycoside Bacterial infections INH Late 2018 Y N Breakthru Kyowa Hakko A2A adenosine receptor Nouriast istradefylline Parkinson's disease PO CRL Late 2018 N N Kogyo/ Biovail antagonist protein absorption FastTrk/ CM-AT CM-AT Curemark Autism PO Late 2018 Y N enhancer Breakthru optum.com/optumrx 2 RxOutlook® 4th Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug osmotic gradient Bronchitol mannitol Pharmaxis enhancer; mucus Asthma/ Cystic fibrosis INH InTrial Late 2018 N Y clearance enhancer combretastatin A4 phosphate vascular targeting agent Neuroendocrine tumors FastTrk/ Zybrestat OXiGENE IV Late 2018 Y Y (fosbretabulin (VTA) (NET)/ Glioma Breakthru tromethamine) pegylated arginine Hepacid ADI-PEG-20 Polaris Hepatic cancer IM InTrial Late 2018 Y Y deiminase Head and Neck cancer/ Ovarian cancer/ Fallopian IV/ FastTrk/ Reolysin pelareorep Oncolytics Biotech human reovirus Late 2018 Y Y tube cancer/ Peritoneal intratumoral Breakthru cancer/ Breast cancer beperminogene Peripheral artery disease AnGes / FastTrk/ Collategene perplasmid angiogenesis (PAD)/ Critical Limb IM Late 2018 Y N Mitsubishi Tanabe Breakthru (AMG-0001) Ischemia (CLI) serelaxin (RLX- recombinant human Reasanz Novartis Heart failure IV InTrial Late 2018 Y N 030) relaxin (rhRlx) agonist ITCA-650 glucagon-like peptide-1 (sustained exenatide Intarcia/ Quintiles/ (GLP-1) receptor Diabetes mellitus SC implant CRL Late 2018 Y N release sustained-release Servier agonist exenatide) Growth hormone somatropin somatropin Opko/ Pfizer enzyme replacement deficiency/ Small for SC InTrial Late 2018 Y Y gestational age (SGA) DCVax-L, glioblastoma Northwest vaccine Glioblastoma SC InTrial Late 2018 Y Y DCVax-Brain multiforme vaccine Biotherapeutics FastTrk/ NeuVax nelipepimut-S Galena vaccine Breast cancer intradermal Late 2018 Y N Breakthru optum.com/optumrx 3 RxOutlook® 4th Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Non-small cell lung tertomotide tertomotide (GV- KAEL-GemVax vaccine cancer (NSCLC)/ Intradermal InTrial Late 2018 Y N (GV-1001) 1001) Melanoma aldoxorubicin aldoxorubicin NantWorks/ CytRx anthracycline derivative Soft tissue sarcoma IV InTrial Late 2018 Y Y Xeglyze abametapir Hatchtech metalloprotease inhibitor Lice TOP CRL Late 2018 N N Fovista (E- Ophthotech/ antiplatelet derived Age-related macular FastTrk/ 10030; OAP- pegpleranib sodium Archemix/ growth factor subunit B Intravitreal Late 2018 Y N degeneration (AMD) Breakthru 030) Astellas/ Novartis (PDGF-B) aptamer Myelofibrosis (MF)/ Myelodysplastic Geron/ Johnson & FastTrk/ GRN-163L imetelstat telomerase inhibitor syndrome (MDS)/ Acute IV Late 2018 Y Y Johnson Breakthru myelogenous leukemia (AML) aldosterone synthase LCI-699 osilodrostat Novartis Cushing's syndrome PO InTrial Late 2018 N Y inhibitor opioid ELI-202 Elite opioid agonist Pain PO InTrial Late 2018 N N (undisclosed) long-acting beta 2 indacaterol/ adrenergic receptor glycopyrronium agonist (LABA)/ long- QVM-149 bromide/ Novartis/ Sosei Asthma INH InTrial Late 2018 N N acting muscarinic mometasone receptor antagonist furoate (LAMA)/ corticosteroid FMX-103 minocycline Foamix tetracyclines Rosacea TOP InTrial Late 2018 N N optum.com/optumrx 4 RxOutlook® 4th Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug AM-111 (D- Xigen/ Auris JNK stress kinase Hearing loss/ Ocular Intratympanic/ FastTrk/ JNKI-1, XG- brimapitide Late 2018 Y Y Medical inhibitor inflammation Intraocular Breakthru 102) Diffuse large B-cell phosphoinositide-3 TG Therapeutics/ lymphoma (DLBCL)/ TGR-1202 umbralisib kinase (PI3K) delta PO InTrial Late 2018 Y Y Rhizen Chronic lymphocytic inhibitor leukemia (CLL) Spinocerebellar ataxia/ glutamate release FastTrk/ BHV-4157 trigriluzole Portage Biotech Obsessive-compulsive PO Late 2018 Y Y inhibitor Breakthru disorder (OCD) SEG-101 crizanlizumab Novartis P-selectin antagonist Sickle cell disease IV InTrial Late 2018 Y Y docosahexaenoic essential fatty acid SC-411 Sancilio Sickle cell disease (SCD) PO InTrial Late 2018 Y Y acid conjugate integrin receptor Ulcerative colitis (UC)/ Entyvio vedolizumab Takeda SC InTrial Late 2018 Y N antagonist Crohn's disease (CD) B-244 B-244 AOBiome antibacterial Acne TOP InTrial Late 2018 Y N phosphodiesterase-4 Otezla apremilast Celgene Psoriasis PO Filed sNDA Late 2018 Y N inhibitor Human lopinavir/ HIV-1 protease inhibitor/ Tentative lopinavir/ritonavir Cipla immunodeficiency virus PO Late 2018 Y N ritonavir CYP3A4 inhibitor Approval (HIV) tamsulosin tamsulosin Female Health/ alpha-adrenergic Benign prostatic PO Filed NDA Late 2018 N N DRS delayed-release Aspen antagonist hyperplasia (BPH) Acute myeloid leukemia PF-04449913 glasdegib maleate Pfizer hedgehog inhibitor PO Filed NDA Late 2018 Y Y (AML) tadalafil phosphodiesterase-5 tadalafil VersaFilm IntelGenx Erectile dysfunction PO Filed NDA Late 2018 Y N VersaFilm (PDE-5) inhibitor optum.com/optumrx 5 RxOutlook® 4th Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug IntelGenx / Red VersaFilm rizatriptan triptans Acute migraines PO Filed NDA Late 2018 N N Hill Biopharma astodrimer sodium VivaGel Starpharma viral attachment inhibitor Bacterial infections VG Filed NDA Late 2018 N N (SPL-7013) nucleoside reverse tenofovir tenofovir disoproxyl transcriptase inhibitor disoproxyl Human fumarate/ (NRTI)/ NRTI/ non- Tentative fumarate/ Hetero Labs immunodeficiency virus PO Late 2018 Y N lamivudine/ nucleoside reverse Approval lamivudine/ (HIV) efavirenz transcriptase inhibitor efavirenz (NNRTI) nucleoside reverse tenofovir tenofovir disoproxyl transcriptase inhibitor disoproxyl Human fumarate/ (NRTI)/ NRTI/ non- Tentative fumarate/ Aurobindo immunodeficiency virus PO Late 2018 Y N lamivudine/ nucleoside reverse Approval lamivudine/ (HIV) efavirenz transcriptase inhibitor efavirenz (NNRTI) nucleoside reverse tenofovir tenofovir disoproxyl transcriptase inhibitor disoproxyl Human fumarate/ (NRTI)/ NRTI/ non- Tentative fumarate/ Cipla immunodeficiency virus PO Late 2018 Y N lamivudine/ nucleoside reverse Approval lamivudine/ (HIV) efavirenz transcriptase inhibitor efavirenz (NNRTI) nucleoside reverse tenofovir tenofovir disoproxyl transcriptase inhibitor disoproxyl Human fumarate/ (NRTI)/ NRTI/ non- Tentative fumarate/ Macleods immunodeficiency virus PO Late 2018 Y N lamivudine/ nucleoside reverse Approval lamivudine/ (HIV) efavirenz transcriptase inhibitor efavirenz (NNRTI) 2019 Possible launch date optum.com/optumrx 6 RxOutlook® 4th Quarter 2018