RxOutlook® 4th 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 sodium zirconium ZS-9 ZS Pharma potassium-binding agent Hyperkalemia PO CRL 4Q2017 N N cyclosilicate recombinant human LR-769 eptacog beta LFB SA Hemophilia IV Filed BLA 4Q2017 Y N Factor VIIa FMX-102 (FXFM-244) minocycline Foamix tetracyclines Impetigo TOP InTrial 4Q2017 N N MK-8228 letermovir Merck quinazoline Cytomegalovirus IV/PO Filed NDA 11/8/2017 N Y Heron neurokinin-1 (NK1) Cinvanti aprepitant Nausea and vomiting IV Filed NDA 11/12/2017 N N Therapeutics receptor antagonist Mucopolysaccharidosis UX-003 (rhGUS) beta-glucuronidase Ultragenyx enzyme replacement IV Filed BLA 11/16/2017 Y Y VII Otsuka/ Proteus Schizophrenia/ Bipolar/ Abilify aripiprazole atypical antipsychotic PO Filed NDA 11/23/2017 N N Digital Health Major Depression opioid receptor agonist RBP-6000 buprenorphine depot Indivior/ QLT Drug addiction SC Filed NDA 11/30/2017 Y N (partial) non-nucleoside reverse Human GlaxoSmithKline/ transcriptase inhibitor/ rilpivirine/ dolutegravir rilpivirine/ dolutegravir immunodeficiency virus PO Filed NDA 12/1/2017 Y N J&J/ ViiV Integrase strand transfer (HIV) inhibitor ertugliflozin ertugliflozin Merck/ Pfizer SGLT2 inhibitor diabetes mellitus PO Filed NDA 12/3/2017 N N optum.com/optumrx 1 RxOutlook® 4th Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug SGLT-2 inhibitor/ ertugliflozin/ sitagliptin ertugliflozin/ sitagliptin Merck/ Pfizer dipeptidyl peptidase-4 Diabetes mellitus PO Filed NDA 12/3/2017 N N (DPP-4) inhibitor ertugliflozin/ ertugliflozin/ metformin Merck/ Pfizer SGLT2 inhibitor/ biguanide Diabetes mellitus PO Filed NDA 12/3/2017 N N metformin glucagon-like peptide-1 semaglutide semaglutide Novo Nordisk Diabetes mellitus SC Filed NDA 12/5/2017 Y N (GLP-1) receptor agonist long-acting muscarinic SUN-101 (EP-101) glycopyrrolate Sunovion COPD INH Filed NDA 12/15/2017 N N receptor antagonist mammalian target of Opsiria sirolimus Santen rapamycin (mTOR) Uveitis Intravitreal Filed NDA 12/24/2017 Y Y inhibitor ethinyl estradiol/ Agile hormonal combination Twirla Pregnancy prevention TOP Filed NDA 12/26/2017 N N levonorgestrel Therapeutics contraceptive Clarus Jatenzo testosterone androgen Hypogonadism PO Filed NDA 12/27/2017 N N Therapeutics Luminesse brimonidine tartrate Bausch and Lomb alpha-2 agonist Ocular rednes OP Filed NDA 12/27/2017 N N Growth hormone Macrilen macimorelin acetate Aeterna Zentaris ghrelin agonist PO Filed NDA 12/30/2017 Y Y deficiency lubiprostone lubiprostone Takeda/ Sucampo chloride channel activator Constipation PO InTrial Late 2017 N N Tarsa/ Unigene Tbria salmon calcitonin osteoclast inhibitor Osteoporosis PO Filed NDA Late 2017 N N Laboratories Non-small cell lung FastTrk/ MVA-MUC1-IL2 TG-4010 Transgene vaccine SC Late 2017 N N cancer (NSCLC) Breakthru arbaclofen extended- Ontinua ER Osmotica muscle relaxant Spasticity PO Filed NDA Late 2017 Y N release Aclaris A-101 (V-101) hydrogen peroxide peroxide Benign pigmented lesions TOP Filed NDA Late 2017 Y N Therapeutics optum.com/optumrx 2 RxOutlook® 4th Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug interleukin-5 receptor benralizumab benralizumab AstraZeneca Asthma/ COPD SC Filed BLA Late 2017 Y N alpha inhibitor Dengvaxia Dengue fever vaccine Sanofi Pasteur vaccine Dengue fever SC Filed BLA Late 2017 N N paracetamol/ Aft Maxigesic acetaminophen/ NSAID Pain PO Filed NDA Late 2017 N N ibuprofen Pharmaceuticals 2018 Possible launch date Non-small cell lung PF-00299804 dacomitinib Pfizer pan-HER inhibitor PO InTrial 2018 Y N cancer (NSCLC) Ovarian cancer/ Non- Hodgkin's lymphoma (NHL)/ Small cell lung MLN-8237 alisertib Millennium aurora kinase A inhibitor PO InTrial 2018 Y Y cancer (SCLC)/ Breast cancer/ Peripheral T-cell lymphoma selective endothelin-A Xinlay atrasentan AbbVie Diabetic nephropathy PO InTrial 2018 Y N receptor antagonist Transition scyllo- beta-amyloid (Abeta) Alzheimer's disease/ scyllo-cyclohexanehexol Therapeutics/ PO InTrial 2018 N N cyclohexanehexol oligomerization inhibitor Down's syndrome Perrigo Niemann-Pick Disease/ FastTrk/ arimoclomol arimoclomol CytRx cytoprotectives Amyotrophic lateral PO 2018 Y Y Breakthru sclerosis phosphatidylserine Non-small cell lung FastTrk/ Tarvacin bavituximab Peregrine IV 2018 Y N receptor antagonist cancer (NSCLC) Breakthru bone marrow-derived Bone PREOB mesenchymal stem cell stem cell therapy Fracture/ Bone necrosis Intraosseus InTrial 2018 Y N Therapeutics therapy DSC-127 aclerastide Derma Sciences angiotensin II analog Diabetic foot ulcers TOP InTrial 2018 N N KAE-609 cipargamin Novartis protein synthesis inhibitor Malaria PO InTrial 2018 N N optum.com/optumrx 3 RxOutlook® 4th Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug aldosterone synthase LCI-699 osilodrostat Novartis Cushing's syndrome PO InTrial 2018 N Y inhibitor Primary IVIG IVIG Prometic immune globulin IV InTrial 2018 Y N immunodeficiency ALKS-8700 (RDC-1559) ALKS-8700 (RDC-1559) Alkermes prodrug Multiple sclerosis PO InTrial 2018 Y N Major depressive FastTrk/ esketamine esketamine Janssen NMDA receptor antagonist Intranasal 2018 N N disorder (MDD) Breakthru FastTrk/ SHP-621 budesonide Shire corticosteroid Eosinophilic esophagitis PO 2018 - 2019 Y Y Breakthru United Pulmonary arterial RemoSynch treprostinil prostacyclin analog IV/SC Filed NDA 1H2018 Y Y Therapeutics hypertension (PAH) Immune Remune HIV-1 vaccine Response vaccine HIV IM Filed BLA 1H2018 Y Y BioPharma Xeglyze abametapir Hatchtech metalloprotease inhibitor Lice TOP CRL 1H2018 N N TX-004HR, TX-12-004HR estradiol TherapeuticsMD estrogen receptor agonist Vaginal atrophy VG CRL 1H2018 N N PSD-502 lidocaine/ prilocaine Plethora/Sciele sodium channel blocker Premature ejaculation TOP InTrial 1Q2018 N N HEPLISAV-B HBV vaccine Merck/ Dynavax vaccine Hepatitis B IM Filed BLA 1Q2018 N N anti-sclerostin monoclonal Evenity romosozumab Amgen Osteoporosis SC CRL 1Q2018 Y N antibody Breast cancer/ Pancreatic cancer/ Pancreatic cancer/ Small cell lung RS7-SN-38 antibody-drug cancer (SCLC)/ Non-small FastTrk/ IMMU-132 sacituzumab govitecan Seattle Genetics IV 1Q2018 Y Y conjugate cell lung cancer (NSCLC)/ Breakthru Colorectal cancer/ Esophageal cancer/ Urinary bladder cancer optum.com/optumrx 4 RxOutlook® 4th Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Advaxis/ Biocon/ FusionVax/ Anal cancer/ Cervical FastTrk/ ADXS-HPV axalimogene filolisbac Sorrento vaccine cancer/ Head and neck IV 1Q2018 Y Y Breakthru Therapeutics/ cancer Taiwan Biotech mometasone furoate/ corticosteroid/ GSP-301 Glenmark Allergic rhinitis NA InTrial 1Q2018 N N olopatadine HCl antihistamine nitric oxide-donating Bausch and Glaucoma/ Ocular Vesneo (Vyzulta) latanoprostene bunod prostaglandin F2-alpha TOP Filed NDA 1Q2018 N N Lomb/ NicOx hypertension analog dexamethasone Ocular Pain/ Allergic Dextenza corticosteroid OP CRL 1Q2018 N N sustained-release Therapeutix conjunctivitis Blastic plasmacytoid dendritic dell neoplasm/ Acute mylegenous leukemia/ Myelodysplastic Stemline interleukin-3 receptor syndrome/ Multiple SL-401 SL-401 IV InTrial 1Q2018 Y Y Therapeutics antagonist myeloma/ Hypereosinophilic syndrome/ Myelofibrosis/ Chronic myelomonocytic leukemia promethazine/ Charleston anti-emetic/ opioid/ CL-108 hydrocodone/ Nausea/ Vomiting/ Pain PO Filed NDA 1Q2018 N N Laboratories analgesic acetaminophen Evosyal botulinum toxin A Alphaeon botulinum toxins Glabellar lines/ Spasticity IM Filed BLA 1Q2018 Y N Theratechnologie Human TNX-355 ibalizumab s/ Biogen/ Roche/ viral entry inhibitor immunodeficiency virus IM/IV/SC Filed sBLA 1/3/2018 Y Y TaiMed (HIV) optum.com/optumrx 5 RxOutlook® 4th Quarter 2017 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug RESOLVE (Sinuva) mometasone furoate Intersect ENT corticosteroid Chronic sinusitis Implant Filed NDA 1/7/2018 Y N Spark Luxturna voretigene neparvovec gene therapy Retinal disease Intraocular Filed BLA 1/12/2018 Y Y Therapeutics Camurus/ opioid receptor agonist CAM-2038 buprenorphine Opioid dependence/ Pain SC Filed NDA 1/19/2018 Y N Braeburn (partial) Cystic fibrosis/ Non-cystic Linhaliq ciprofloxacin Aradigm/ Grifols fluoroquinolone INH Filed NDA 1/26/2018 Y Y fibrosis bronchiectasis [177]Lutetium- DOTA[0]-Tyr[3]- somatostatin receptor Gastroenteropancreatic Lutathera Novartis INJ Filed NDA 1/26/2018 Y Y Octreotate (177-Lu- agonist neuroendocrine tumors Dotatate) Portola/ Pfizer/ recombinant Factor Xa AndexXa andexanet alfa Bristol-Myers Reversal agent IV Filed NDA 2/2/2018 Y N inhibitor antidote Squibb Tlando testosterone Lipocine androgen Hypogonadism PO Filed NDA 2/8/2018 N N dexamethasone Dexycu Icon Bioscience corticosteroid Ocular inflammation Intraocular Filed NDA 2/12/2018 N/A N controlled-release HIV integrase inhibitors/ bictegravir/ Human nucleoside reverse GS-9883/F/TAF emtricitabine/ Gilead immunodeficiency virus PO Filed NDA 2/12/2018 Y N transcriptase