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RxOutlook® 2nd Quarter 2017

OptumRx brand pipeline forecast

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date 2017 Possible launch date Amphora Amphora Evofem spermicidal agent Pregnancy prevention VG Filed NDA 2017 N N Xeglyze abametapir Hatchtech metalloprotease inhibitor Lice TOP Filed NDA 2017 N N Dr. Reddy's Tentative Zenavod doxycycline tetracyclines Rosacea PO 2017 N N Laboratories Approval

N9-GP nonacog beta pegol Novo Nordisk factor Hemophilia IV Filed BLA 2Q2017 Y Y Regeneron/ Sanofi- interleukin-6 receptor (IL- Kevzara sarilumab (REGN-88) / Uveitis SC Filed NDA 5/22/2017 Y N Aventis 6R) Isentress raltegravir Merck integrase inhibitor HIV PO Filed sNDA 5/27/2017 Y N

Immune Response Remune HIV-1 vaccine HIV IM Filed BLA Mid-2017 Y Y BioPharma Major depressive disorder Travivo ER GSK/Fabre-Kramer 5-HT-1A receptor agonist PO CRL Mid-2017 N N (MDD) Ontinua ER arbaclofen extended-release Osmotica muscle relaxant Spasticity PO Filed NDA Mid-2017 Y N

long-acting muscarinic Chronic obstructive pulmonary SUN-101 (EP-101) glycopyrrolate Sunovion INH Filed NDA 2H2017 N N receptor antagonist diseaser (COPD) Arcion Therapetuics/ alpha-2-adrenoceptor FastTrk/ clonidine (ARC-4558) clonidine (ARC-4558) Diabetic neuropathy TOP 2H2017 N N BioDelivery Sciences agonist Breakthru etirinotecan pegol etirinotecan pegol (NKTR- Breast cancer/ Colorectal FastTrk/ Nektar topoisomerase inhibitor IV 2H2017 Y Y (NKTR-102) 102) cancer/ Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Cardiorentis / vasodilator (synthetic FastTrk/ ularitide acetate ularitide acetate Cornerstone Heart failure IV 2H2017 Y N human natriuretic peptide) Breakthru Therapeutics FastTrk/ NeuVax nelipepimut-S Galena vaccine Breast cancer intradermal 2H2017 Y N Breakthru

Asthma/ GST/ Mastocytosis/ Multiple myeloma/ Prostate cancer/ Crohn's disease/ protein tyrosine kinase masitinib masitinib AB Science Multiple sclerosis/ Rheumatoid PO InTrial 2H2017 N Y inhibitor arthritis/ Pancreatic cancer/ Amyotrophic lateral sclerosis (ALS)

pegylated phenylalanine Peg-Pal BioMarin enzyme replacement Phenylketonuria (PKU) SC InTrial 2H2017 Y Y ammonia lyase

opioid receptor agonist SL/ buprenorphine buprenorphine Insys Therapeutics Pain InTrial 2H2017 N N (partial) Transmucosal

aspirin/ angiotensin aspirin/ lisinopril/ converting enzyme inhibitor/ CardiaPill CardioPharma Cardiovascular disease PO InTrial 2H2017 N N simvastatin HMG Co-A reductase inhibitor Schizophrenia/ Schizoaffective LY-03004 risperidone ER Luye atypical antipsychotic IM InTrial 2H2017 Y N disorder human normal IVIG-SN Green Cross immune globulin (IVIG) Primary immunodeficiency IV CRL 2H2017 Y N immunoglobulin G A-101 (V-101) hydrogen peroxide Aclaris Therapeutics peroxide Benign pigmented lesions TOP InTrial 2H2017 Y N salmon calcitonin (TAR01- Tarsa/ Unigene Tbria osteoclast inhibitor Osteoporosis PO Filed NDA 2H2017 N N 201) Laboratories irreversible pan-ErbB neratinib neratinib Puma Biotechnology Breast cancer PO Filed NDA 2H2017 Y N receptor tyrosine kinase

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date inhibitor

EUSA/ Aperion/ APN-311 beta Endo/ Gen Ilac/ disialoganglioside Neuroblastoma SC InTrial 2H2017 Y Y Medison epinephrine epinephrine Adamis catecholamine Emergency allergic reactions INJ Filed NDA 6/15/2017 N N

Baxdela delafloxacin Melinta / Wakunaga fluoroquinolone Bacterial IV/PO Filed NDA 6/19/2017 Y N Attention deficit hyperactivity Cotempla XR-ODT methylphenidate XR-ODT Neos Therapeutics CNS stimulant PO Filed NDA 6/20/2017 N N disorder (ADHD) amphetamine/ adrenergic receptor Attention deficit hyperactivity SHP-465 Shire PO Filed NDA 6/20/2017 N N dextroamphetamine salts agonists disorder (ADHD) Remodulin Implantable Pulmonary arterial hypertension treprostinil United Therapeutics prostacyclin analog IV/SC Filed NDA 6/21/2017 Y Y System (PAH) GF-00100100 ozenoxacin Medimetriks/ Cipher quinolone (non-fluorinated) Bacterial infections TOP Filed NDA 6/22/2017 N N Deep vein thrombosis (DVT)/ MK-4448 betrixaban Portola/ Millennium factor Xa inhibitor PO Filed NDA 6/24/2017 N N Pulmonary embolism (PE) Chronic lymphocytic leukemia / hyaluronidase CD20 monoclonal (CLL)/ Non-Hodgkin lymphoma MabThera Roche/ Halozyme SC Filed BLA 6/26/2017 Y N (recombinant, human) antibody (NHL)/ Diffuse large B-cell lymphoma (DLBCL) B-lymphocyte stimulator Systemic lupus erythematosus Benlysta belimumab GlaxoSmithKline SC Filed BLA 7/2017 Y N (BLyS)-specific inhibitor (SLE) Sickle beta thalessemia/ Sickle Endari L-glutamine Emmaus Medical PO Filed NDA 7/7/2017 N Y cell anemia anti-sclerostin monoclonal Evenity romosozumab Osteoporosis SC Filed BLA 7/19/2017 Y N antibody dexamethasone sustained- Dextenza Ocular Therapeutix corticosteroid Pain/ Allergic conjunctivitis OP Filed NDA 7/19/2017 N N release methylphenidate modified- Highland Attention deficit hyperactivity Benjorna CNS stimulant PO Filed NDA 7/30/2017 N N release Therapeutics disorder (ADHD) FastTrk/ tafenoquine tafenoquine GSK/MMV modulator Malaria PO 3Q2017 N Y Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date promethazine/ Charleston anti-emetic/ opioid/ CL-108 hydrocodone/ Nausea/ Vomiting/ Pain PO CRL 3Q2017 N N Laboratories analgesic acetaminophen 1 phosphatidylinositol 3 BKM-120 buparlisib Novartis Breast cancer PO InTrial 3Q2017 Y N kinase inhibitor BAX-817 BAX-817 Baxter factor VIIa stimulant Hemophilia IV InTrial 3Q2017 Y N neurokinin-1 (NK-1) Varubi rolapitant Tesaro/Opko Health Nausea and vomiting (N/V) IV CRL 3Q2017 Y N receptor antagonist QVAR BAI beclomethasone Teva corticosteroid Asthma INH InTrial 3Q2017 N N

Medidur fluocinolone acetonide Alimera/pSivida corticosteroid Posterior uveitis INJ InTrial 3Q2017 Y N urate transporter1 and organic anion transporter 4 Duzallo lesinurad/ allopurinol AstraZeneca Gout PO Filed NDA 8/3/2017 N N inhibitor/ hypoxanthine analog Vernalis/ Tris CCP-08 CCP-08 undisclosed Viral rhinitis PO Filed NDA 8/4/2017 Y N Pharma NS5A inhibitor/ nucleotide sofosbuvir/ velpatasvir/ sofosbuvir/ velpatasvir/ analog NS5B polymerase Gilead (HCV) PO Filed NDA 8/8/2017 Y N voxilaprevir voxilaprevir inhibitor/ pan-genotypic NS3 protease inhibitor HEPLISAV-B HBV vaccine Merck/ Dynavax vaccine Hepatitis B (HBV) IM Filed BLA 8/10/2017 N N NS3 protease inhibitor/ ABT-493/ ABT-530 glecaprevir/ pibrentasvir AbbVie Hepatitis C (HCV) PO Filed NDA 8/19/2017 Y N NS5A inhibitor carbapenem/ beta- Carbavance meropenem/ vaborbactam Medicines Company Bacterial infections IV Filed NDA 8/20/2017 N N lactamase inhibitor anti-CD22 antibody-drug inotuzumab ozogamicin / UCB Acute myeloid leukemia (AML) IV Filed NDA 8/20/2017 Y Y conjugate Dyskinesia in Parkinson's Nurelin amantadine ER Adamas antiviral PO Filed NDA 8/24/2017 N Y disease/ Multiple sclerosis nitric oxide-donating Bausch and Lomb/ Vesneo (Vyzulta) latanoprostene bunod prostaglandin F2-alpha Glaucoma/ Ocular hypertension TOP Filed NDA 8/24/2017 N N NicOx analog

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date anti-rabies immunoglobulin KamRAB Kamada/ Kedrion immune globulin Rabies IM Filed BLA 8/29/2017 Y N (human) human C1-esterase inhibitor Haegarda CSL Limited C1 inhibitor Angioedema SC Filed BLA 8/30/2017 Y N concentrate

isocitrate dehydrogenase 2 Acute myelogenous leukemia AG-221 enasidenib Celgene/ Agios PO Filed NDA 8/30/2017 Y Y (IDH2) inhibitor (AML)/ Solid tumors

interleukin-6 (IL-6) sirukumab sirukumab Janssen/ GSK Rheumatoid arthritis SC Filed BLA 9/2017 Y N monoclonal antibody AC-170 Nicox antihistamine Allergic conjunctivitis TOP Filed NDA 9/8/2017 N N angiotensin receptor EZR-104 valsartan controlled-release Ezra Innovations Heart failure/ Hypertension PO Filed NDA 9/10/2017 N N blocker (ARB) amphetamine extended- Attention deficit hyperactivity amphetamine XR-liquid Neos Therapeutics stimulant PO Filed NDA 9/17/2017 N N release disorder (ADHD) Solosec secnidazole Symbiomix 5-nitroimidazole antibiotic Urinary tract PO Filed NDA 9/17/2017 N N phosphodiesterase-5 (PDE- pharmafilm tadalafil pharmafilm MonoSol Rx Erectile dysfunction PO Filed NDA 9/18/2017 Y N 5) inhibitor inhaled corticosteroid (ICS)/ fluticasone furoate/ fluticasone furoate/ long-acting muscarinic Chronic obstructive pulmonary GSK/ Innoviva INH Filed NDA 9/21/2017 N N umeclidinium/ vilanterol umeclidinium/ vilanterol agent (LAMA)/ long-acting disease (COPD) beta agonist (LABA) ITCA-650 (sustained Intarcia/ Quintiles/ glucagon-like peptide-1 exenatide sustained-release Diabetes mellitus SC implant Filed NDA 9/21/2017 N N release exenatide) Servier (GLP-1) receptor agonist

Acute lymphoblastic leukemia chimeric antigen receptor (ALL)/ Diffuse large B-cell CTL-019 tisagenlecleucel Novartis IV Filed BLA 9/29/2017 Y Y (CAR) T cell therapy lymphoma (DLBCL)/ Chronic lymphocytic leukemia (CLL)

antibody-drug conjugate (CD-22 mAb linked to Mylotarg Pfizer Acute myeloid leukemia (AML) IV Filed BLA 9/30/2017 Y Y calicheamicin, a cytotoxic agent)

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date OptiNose fluticasone propionate OptiNose AS corticosteroid Nasal polyps Intranasal Filed NDA 9/30/2017 N N Non-Hodgkin lymphoma/ Mantle cell lymphoma/ Diffuse Large B- chimeric antigen receptor Cell Lymphoma (DLBCL)/ CAR-T ciloleucel axicabtagene ciloleucel Kite IV Filed NDA 9/30/2017 Y Y (CAR) T cell therapy Chronic lymphocytic leukemia (CLL)/ Small cell lymphocytic lymphoma (SLL) pregabalin controlled- (PHN)/ Lyrica CR Pfizer GABA structural analogue PO Filed sNDA 10/2/2017 N N release Fibromyalgia 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 hydroxyprogesterone Makena Lumara Health progestin Preterm labor SC Filed sNDA 10/14/2017 Y Y caproate 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 gene transcription Duchenne muscular dystrophy/ Translarna ataluren PTC Therapeutics PO Filed NDA 10/24/2017 Y Y modulator Mucopolysaccharidosis (MPS) Eagle folate analog metabolic Non-small cell lung cancer EP-5101 pemetrexed IV Filed NDA 10/30/2017 Y N Pharmaceuticals 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 sodium zirconium ZS-9 ZS Pharma potassium-binding agent Hyperkalemia PO CRL 4Q2017 N N cyclosilicate DNA-dependent RNA Zemcolo rifamycin Cosmo/ Dr. Falk Traveler's diarrhea PO InTrial 4Q2017 N N polymerase inhibitor 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 BN FastTrk/ Prostvac rilimogene glafolivec vaccine Prostate cancer SC 4Q2017 Y N ImmunoTherapeutics Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Diffuse large B-cell lymphoma Pixuvri pixantrone Cell Therapeutics anthracycline derivative (DLBCL)/ Follicular lymphoma/ IV CRL 4Q2017 Y N Non-Hodgkin's lymphoma (NHL) Portola/ Pfizer/ recombinant Factor Xa AndexXa andexanet alfa Reversal agent IV CRL 4Q2017 Y N Bristol-Myers Squibb inhibitor antidote reparixin reparixin Dompe interleukin-8 (IL-8) inhibitor Pancreatic islet transplantation IV InTrial 4Q2017 Y Y FastTrk/ Civacir hepatitis C immunoglobulin Biotest immunoglobulin Hepatitis C (HCV) IV 4Q2017 Y Y Breakthru glioblastoma multiforme Northwest DCVax-L, DCVax-Brain vaccine Glioblastoma SC InTrial 4Q2017 Y Y vaccine Biotherapeutics Non-small cell lung cancer tertomotide tertomotide KAEL-GemVax vaccine Intradermal InTrial 4Q2017 Y N (NSCLC)/ RNA polymerase inhibitor/ rifabutin/ amoxicillin/ RHB-105 RedHill Biopharma penicillin/ proton pump H. pylori eradication PO InTrial 4Q2017 N N pantoprazole inhibitor (PPI) Cystic fibrosis bacterial Cipro Inhale DPI Nektar/ Bayer fluoroquinolone infections/ Non-cystic fibrosis INH InTrial 4Q2017 N Y bronchiectasis Primary immunodeficiency/ RI-002 RI-002 ADMA Biologics immunoglobulin Respiratory syncytial virus IV CRL 4Q2017 Y N (RSV)/ Bacterial infections ABX-203 ABX-203 Abivax vaccine Hepatitis B (HBV) SC/ intranasal InTrial 4Q2017 N N Colorectal cancer/ Gastric BBI-608 napabucasin Sumitomo Dainippon stem cell inhibitor PO InTrial 4Q2017 Y Y cancer amantadine extended- Osmolex ER Osmotica antiviral Dyskinesia PO InTrial 4Q2017 N Y release Medicines MDL moxidectin Development for chloride channel agonist Parasitic infections PO InTrial 4Q2017 N N Global Health

Aeroquin levofloxacin HCl Raptor fluoroquinolone Cystic fibrosis INH InTrial 4Q2017 Y Y Theratechnologies/ Human immunodeficiency virus FastTrk/ TNX-355 ibalizumab viral entry inhibitor IM/IV/SC 4Q2017 Y Y / Roche/ (HIV) Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date TaiMed

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 herpes GSK vaccine Herpes zoster IM Filed BLA 4Q2017 Y N insulin aspart (ultra fast FIAsp Novo Nordisk fast-acting insulin Diabetes mellitus SC CRL 4Q2017 N N acting) interleukin-23 (IL-23) guselkumab guselkumab Johnson & Johnson Psoriasis/ Psoriatic arthritis SC Filed BLA 4Q2017 Y N inhibitor Chronic lymphocytic leukemia ACP-196 acalabrutinib Acerta/ Merck tyrosine kinase inhibitor (CLL)/ Small cell lymphocytic PO InTrial 4Q2017 Y Y lymphoma (SLL)

Erythropoietic protoporphyria melanocortin receptor 1 Scenesse afamelanotide Clinuvel (EPP)/ Polymorphous light SC implant Filed NDA Late 2017 Y Y (MC-1) agonist eruption (PLE/PMLE)/ Vitiligo

Transthyretin (TTR) FastTrk/ ISIS-TTRRx ISIS-TTRRx GSK/ Ionis antisense RNA modulator amyloidosis/ Transthyretin SC Late 2017 Y Y Breakthru (TTR) cardiomyopathy aspartyl-alanyl Ampio Ampion immunomodulator Osteoarthritis Intra-articular InTrial Late 2017 Y N diketopiperazine Pharmaceuticals 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 Cyclacel / Daiichi sapacitabine sapacitabine antimetabolite Acute myeloid leukemia (AML) PO InTrial Late 2017 Y Y Sankyo allogeneic neonatal Healthpoint HP802-247 HP802-247 keratinocytes and Venous leg ulcer TOP InTrial Late 2017 Y N Biotherapeutics fibroblasts

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date growth hormone Helsinn / Novo Anorexia/ Cachexia (cancer- FastTrk/ anamorelin anamorelin secretagogue receptor PO Late 2017 Y N Nordisk 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 astodrimer sodium (SPL- FastTrk/ VivaGel Starpharma viral attachment inhibitor Bacterial infections VG Late 2017 N N 7013) Breakthru 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 quizartinib quizartinib Ambit Biosciences Acute myeloid leukemia (AML) PO InTrial Late 2017 Y N kinase inhibitor tergenpantucel-L Non-small cell lung cancer HyperAcute Lung (turgenpumatucel-L, NewLink Genetics immunotherapy IV InTrial Late 2017 Y N (NSCLC) tergenpumatucel-L) [177]Lutetium-DOTA[0]- Advanced somatostatin receptor Gastroenteropancreatic Lutathera Tyr[3]-Octreotate (177-Lu- Accelerator INJ CRL Late 2017 Y Y agonist neuroendocrine tumors Dotatate) Applications pegylated arginine Hepacid ADI-PEG-20 Polaris Hepatic cancer IM InTrial Late 2017 Y Y deiminase Threshold FastTrk/ glufosfamide glufosfamide Pharmaceuticals/ alkylating agent Pancreatic cancer IV Late 2017 Y Y Breakthru Eleison Growth hormone deficiency/ somatropin somatropin Opko/ Pfizer enzyme replacement SC InTrial Late 2017 Y Y Small for gestational age (SGA) transmembrane activator EMD Serono / Systemic lupus erythematosus atacicept (TACI-Ig) atacicept (TACI-Ig) and CAML interactor (TACI) SC InTrial Late 2017 Y N Bristol-Myers Squibb (SLE) receptor-immunoglobulin FastTrk/ Epidiolex cannabidiol GW Pharmaceuticals cannabinoid product Seizures PO Late 2017 Y Y Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Ophthotech/ antiplatelet derived growth Fovista (E-10030; OAP- Age-related macular FastTrk/ pegpleranib sodium Archemix/ Astellas/ factor subunit B (PDGF-B) Intravitreal Late 2017 Y N 030) degeneration (AMD) Breakthru Novartis aptamer Chronic lymphocytic leukemia (CLL)/ Small cell lymphocytic ublituximab TG Therapeutics CD-20 monoclonal antibody lymphoma (SLL)/ Mantle cell IV InTrial Late 2017 Y Y lymphoma (MCL)/ Multiple sclerosis SPK-RPE65 voretigene neparvovec Spark Therapeutics gene therapy Nyctalopia Intraocular Filed BLA Late 2017 Y Y Non-small cell lung cancer FastTrk/ MVA-MUC1-IL2 TG-4010 Transgene vaccine SC Late 2017 N N (NSCLC) Breakthru mycolic acid biosynthesis Deltyba delamanid Otsuka Tuberculosis PO InTrial Late 2017 N N inhibitor non-nucleoside reverse GlaxoSmithKline/ transcriptase inhibitor Human immunodeficiency virus rilpivirine/ dolutegravir rilpivirine/ dolutegravir PO InTrial Late 2017 Y N J&J (NNRTI)/ Integrase strand (HIV) transfer inhibitor (ISTI)

AstraZeneca/ / Bristol- glucagon-like peptide-1 exenatide exenatide Diabetes mellitus SC InTrial Late 2017 N N Myers Squibb/ Eli (GLP-1) receptor agonist Lilly

Primatene HFA epinephrine Amphastar catecholamine Asthma INH CRL Late 2017 N N factor IXa/ bi- FastTrk/ ACE-910 emicizumab Roche/ Chugai Hemophilia SC Late 2017 Y Y specific antibody Breakthru Seciera cyclosporine Auven Therapeutics immunosuppressant Dry eyes TOP InTrial Late 2017 Y N Acute lymphocytic leukemia EZN-2285 calaspargase pegol Baxalta enzyme therapy IM/IV InTrial Late 2017 Y N (ALL) opioid receptor agonist FastTrk/ RBP-6000 buprenorphine depot Indivior/ QLT Drug addiction SC Late 2017 Y N (partial) Breakthru human plasminogen human plasminogen ProMetic/ Hematech plasminogen Plasminogen deficiency IV Filed BLA Late 2017 Y Y

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Primary biliary ursodeoxycholic acid ursodeoxycholic acid Retrophin/ Asklepion derivative PO InTrial Late 2017 Y N cirrhosis/cholangitits Female Health/ Benign prostatic hyperplasia tamsulosin DRS tamsulosin DRS alpha-adrenergic antagonist PO InTrial Late 2017 N N Aspen (BPH) naloxone naloxone Amphastar opioid antagonist Opioid dependence Intranasal CRL Late 2017 N N interleukin-5 receptor (IL- Asthma/ Chronic obstructive benralizumab benralizumab AstraZeneca SC Filed BLA Late 2017 Y N 5R) alpha inhibitor pulmonary disease (COPD) Dengvaxia Dengue fever vaccine Sanofi Pasteur vaccine Dengue fever SC Filed BLA Late 2017 N N acetaminophen/ Non- Maxigesic paracetamol/ ibuprofen Aft Pharmaceuticals steroidal anti-inflammatory Pain PO Filed NDA Late 2017 N N drug (NSAID) ertugliflozin ertugliflozin Merck/ Pfizer SGLT2 inhibitor Diabetes mellitus PO Filed NDA 12/3/2017 N N SGLT-2 inhibitor/ dipeptidyl ertugliflozin/ sitagliptin ertugliflozin/ sitagliptin Merck/ Pfizer peptidase-4 (DPP-4) Diabetes mellitus PO Filed NDA 12/3/2017 N N inhibitor ertugliflozin/ metformin ertugliflozin/ metformin Merck/ Pfizer SGLT2 inhibitor/ biguanide Diabetes mellitus PO Filed NDA 12/3/2017 N N Jazz pyrimidine antimetabolite/ Vyxeos cytarabine/ daunorubicin Acute myeloid leukemia (AML) IV Filed NDA 12/4/2017 Y Y Pharmaceuticals anthracycline glucagon-like peptide-1 semaglutide semaglutide Novo Nordisk Diabetes mellitus SC/ PO Filed NDA 12/5/2017 Y N (GLP-1) receptor agonist mammalian target of Opsiria sirolimus Santen Uveitis Intravitreal Filed NDA 12/24/2017 Y Y rapamycin (mTOR) inhibitor 2018 Possible launch date Polycythemia vera (PV)/ PharmaEssentia/ ropeginterferon alfa-2b ropeginterferon alfa-2b interferon Myelofibrosis (MF)/ Essential SC InTrial 1H2018 Y Y AOP Orphan thrombocythemia (ET) Non-small cell lung cancer PF-00299804 dacomitinib Pfizer pan-HER inhibitor PO InTrial 2018 Y N (NSCLC) Ovarian cancer/ Non-Hodgkin's MLN-8237 alisertib Millennium aurora kinase A inhibitor PO InTrial 2018 Y Y lymphoma (NHL)/ Small cell

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date lung cancer (SCLC)/ Breast cancer/ Peripheral T-cell lymphoma selective endothelin-A Xinlay atrasentan AbbVie Diabetic nephropathy PO InTrial 2018 Y N receptor antagonist Transition beta-amyloid (Abeta) Alzheimer's disease/ Down's scyllo-cyclohexanehexol scyllo-cyclohexanehexol Therapeutics/ PO InTrial 2018 N N oligomerization inhibitor syndrome Niemann-Pick Disease (NPD)/ FastTrk/ arimoclomol arimoclomol CytRx cytoprotectives Amyotrophic lateral sclerosis PO 2018 Y Y Breakthru (ALS) phosphatidylserine receptor Non-small cell lung cancer FastTrk/ Tarvacin bavituximab Peregrine IV 2018 Y N antagonist (NSCLC) Breakthru combretastatin A4 vascular targeting agent Ovarian cancer/ Neuroendocrine FastTrk/ Zybrestat phosphate (fosbretabulin OXiGENE IV 2018 Y Y (VTA) tumors (NET)/ Glioma Breakthru tromethamine) bone marrow-derived PREOB mesenchymal stem cell Bone Therapeutics stem cell therapy Fracture/ Bone necrosis Intraosseus InTrial 2018 Y N therapy androgen receptor JNJ-56021927 apalutamide Janssen Prostate cancer PO InTrial 2018 N N antagonist 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 aldosterone synthase LCI-699 Novartis Cushing's syndrome PO InTrial 2018 N Y inhibitor Major depressive disorder FastTrk/ esketamine esketamine Janssen NMDA receptor antagonist Intranasal 2018 N N (MDD) Breakthru beta-glucuronidase Mucopolysaccharidosis VII UX-003 (rhGUS) enzyme replacement IV InTrial 2018 Y Y (recombinant) (MPS-VII) IVIG IVIG Prometic immune globulin Primary immunodeficiency IV InTrial 2018 Y N

ALKS-8700 (RDC-1559) ALKS-8700 (RDC-1559) Alkermes Multiple sclerosis (MS) PO InTrial 2018 Y N

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date RESOLVE mometasone furoate Intersect ENT corticosteroid Chronic sinusitis Implant Filed NDA 1Q2018 Y N

PSD-502 lidocaine/ prilocaine Plethora/Sciele sodium channel blocker Premature ejaculation TOP InTrial 1Q2018 N N

Cystic fibrosis/ Non-cystic FastTrk/ Pulmaquin ciprofloxacin Aradigm/ Grifols fluoroquinolone INH 1Q2018 Y Y fibrosis bronchiectasis Breakthru Breast cancer/ Non-small cell FastTrk/ LY-2835219 bemaciclib (abemaciclib) Eli Lilly cyclin-dependent kinases lung cancer (NSCLC)/ Mantle PO 1Q2018 Y N Breakthru cell lymphoma

Familial chylomicronemia ISIS 304801 volanesorsen Ionis antisense drug SC InTrial 1Q2018 Y Y syndrome (FCS)/ Lipodystrophy

Breast cancer/ Pancreatic cancer/ Pancreatic cancer/ Small cell lung cancer (SCLC)/ RS7-SN-38 antibody-drug FastTrk/ IMMU-132 Seattle Genetics Non-small cell lung cancer IV 1Q2018 Y Y conjugate Breakthru (NSCLC)/ Colorectal cancer/ Esophageal cancer/ Urinary bladder cancer Advaxis/ Biocon/ ADXS-HPV (ADXS-11- FusionVax/ Sorrento Anal cancer/ Cervical cancer/ FastTrk/ 001, Lm-LLO-E7, lovaxin axalimogene filolisbac vaccine IV 1Q2018 Y Y Therapeutics/ Head and neck cancer Breakthru C) Taiwan Biotech Azedra (Ultratrace iobenguane (I-131) Progenics radiopharmaceuticals Neuroendrocine tumors (NET) IV Filed NDA 1Q2018 Y Y MIBG) ZTlido lidocaine Scilex sodium channel blocker Postherpetic neuralgia (PHN) TOP CRL 1Q2018 N N nonsteroidal anti- inflammatory drug (NSAID)/ KIT-302 celecoxib/ amlodipine Kitov Hypertension/ Osteoarthritis PO InTrial 1Q2018 N N calcium channel blocker (CCB) anti-DLL3 monoclonal Rova-T AbbVie Small cell lung cancer (SCLC) IV InTrial 1Q2018 Y Y antibody

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date mometasone furoate/ GSP-301 Glenmark corticosteroid/ antihistamine Allergic rhinitis NA InTrial 1Q2018 N N olopatadine HCl dexamethasone controlled- Dexycu Icon Bioscience corticosteroid Ocular inflammation Intraocular Filed NDA 1Q2018 N/A N release IntelGenx / Red Hill VersaFilm rizatriptan triptans Headache PO CRL 1Q2018 N N Biopharma ELI-200 oxycodone/ naltrexone Elite opioid agonist Pain PO CRL 1Q2018 N N IDP-118 tazarotene/ halobetasol Valeant retinoid/ corticosteroid Psoriasis TOP InTrial 1Q2018 N N

Blastic plasmacytoid dendritic dell neoplasm/ Acute mylegenous leukemia (AML)/ Myelodysplastic syndrome Stemline interleukin-3 (IL-3) receptor SL-401 SL-401 (MDS)/ Multiple myeloma (MM)/ IV InTrial 1Q2018 Y Y Therapeutics antagonist Hypereosinophilic syndrome/ Myelofibrosis/ Chronic myelomonocytic leukemia (CMML)

rho kinase-norepinephrine Rhopressa netarsudil mesylate Aerie Glaucoma/ Ocular hypertension TOP Filed NDA 2/28/2018 N N transport protein inhibitor ethinyl estradiol/ hormonal combination Twirla Agile Therapeutics Pregnancy prevention TOP CRL 2Q2018 N N levonorgestrel contraceptive opioid receptor agonist buprenorphine/ Major depressive disorder FastTrk/ ALKS-5461 Alkermes (partial)/ opioid receptor PO 2Q2018 N N samidorphan (MDD) Breakthru antagonist CVT-301 levodopa Acorda antiparkinson Parkinson's disease INH InTrial 2Q2018 N N FastTrk/ MK-8228 letermovir Merck quinazoline Cytomegalovirus (CMV) IV/PO 2Q2018 N Y Breakthru Zoptrex zoptarelin doxorubicin Aeterna Zentaris anthracycline derivative Endometrial cancer IV InTrial 2Q2018 Y N

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date

anti-CD45 monoclonal- anti-CD45 monoclonal Acute myeloid leukemia (AML)/ Iomab-B Actinium IV InTrial 2Q2018 Y Y antibody BC8-I-131 antibody Myelodysplastic syndrome

darunavir/ emtricitabine/ protease inhibitor/ NRTI/ Human immunodeficiency virus D/C/F/TAF cobicistat/ tenofovir Johnson & Johnson PO InTrial 2Q2018 Y N boosting agent/ NRTI (HIV) alafenamide FastTrk/ CK-2017357 (CK-357) tirasemtiv Cytokinetics troponin activator Amyotrophic lateral sclerosis PO 2Q2018 Y Y Breakthru Radiation poisoning/ Colorectal FastTrk/ Protectan entolimod Cleveland BioLabs TLR5 receptor modulator SC 2Q2018 Y Y cancer Breakthru Non-small cell lung cancer FastTrk/ PF-06463922 lorlatinib Pfizer tyrosine kinase inhibitor PO 2Q2018 Y N (NSCLC) Breakthru corrector ion channel FastTrk/ ivacaftor/ tezacaftor ivacaftor/ tezacaftor Vertex Cystic fibrosis PO 2Q2018 Y Y modulator Breakthru estrogen receptor TX-001HR (TX-12- estradiol/ progesterone TherapeuticsMD agonist/progesterone Menopause PO InTrial 2Q2018 N N 001HR) receptor agonist TX-004HR, TX-12- estradiol TherapeuticsMD estrogen receptor agonist Vaginal atrophy VG Filed NDA 2Q2018 N N 004HR fostamatinib Rigel oral SYK inhibitor Immune thrombocytopenia PO Filed NDA 4/17/2018 Y Y Melanoma/ Fallopian tube Array BioPharma/ cancer/ Ovarian cancer/ MEK-162 binimetinib MEK inhibitor PO InTrial Mid-2018 Y N Novartis Peritoneal cancer/ Colorectal cancer prostaglandin (PG) receptor RayVa (Vitaros) alprostadil / Apricus Erectile dysfunction TOP CRL Mid-2018 N N agonist brincidofovir DNA-directed DNA Adenovirus/ Cytomegalovirus FastTrk/ CMX001 Chimerix PO Mid-2018 N N hexadecyloxypropyl ester polymerase inhibitor (CMV) Breakthru FastTrk/ BAY-41-6551 amikacin Nektar/ Bayer aminoglycoside Bacterial infections INH Mid-2018 Y N Breakthru leukocyte interleukin (CS- Head and Neck cancer/ Multikine CEL-SCI immunomodulator SC InTrial Mid-2018 Y Y 001P3) Squamous cell carcinoma tildrakizumab tildrakizumab Merck interleukin-23 (IL-23) Psoriasis SC InTrial Mid-2018 Y N

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date inhibitor

dopamine receptor APD-421 amisulpride Acacia Nausea/ Vomiting IV InTrial Mid-2018 N N antagonist synaptic vesicle protein AGB-101 levetiracetam AgeneBio Alzheimer's disease PO InTrial Mid-2018 N N modulator Shionogi/ S-649266 cefiderocol cephalosporin antibiotic Bacterial infections IV InTrial Mid-2018 Y N GlaxoSmithKiline XaraColl bupivacaine implant Innocoll sodium channel blocker Pain implant CRL Mid-2018 Y N Pulmonary arterial hypertension Trevyent trevyent SteadyMed prostacyclin analog SC InTrial Mid-2018 Y Y (PAH) Recro Pharma/ nonsteroidal anti- N-1539 meloxicam Post-surgical pain IV InTrial Mid-2018 Y N Alkermes inflammatory drug (NSAID) opioid receptor agonist FastTrk/ CAM-2038 buprenorphine Camurus/ Braeburn Opioid dependence/ Pain SC Mid-2018 Y N (partial) Breakthru FastTrk/ TRV-130 oliceridine Trevena opioid receptor agonist Pain IV Mid-2018 N N Breakthru Shield Therapeutics/ Anemia/ Irritable bowel Feraccru ferric trimaltol iron replacement PO InTrial Mid-2018 N N AOP Orphan Pharma syndrome IDP-122 halobetasol propionate Valeant corticosteroid Psoriasis TOP InTrial Mid-2018 N N C-C chemokine receptor 5 Human immunodeficiency virus FastTrk/ PRO-140 PRO-140 CytoDyn IV/SC 2H2018 Y N (CCR5) antagonist (HIV) Breakthru Semprana dihydroergotamine mesylate MAP / dihydroergotamine Headache INH InTrial 2H2018 N N

Macrilen macimorelin acetate Aeterna Zentaris ghrelin agonist Growth hormone deficiency PO CRL 2H2018 Y Y

Resolor prucalopride Shire 5-HT-4 receptor agonist Chronic constipation PO InTrial 2H2018 N N Repros/ Gedeon progesterone receptor Proellex telapristone acetate Uterine fibroids/ Endometriosis PO InTrial 2H2018 N N Richter antagonist Clostridium difficile-associated FastTrk/ cadazolid cadazolid quinolonyl-oxazolidinone PO 2H2018 N N diarrhea (CDAD) Breakthru

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date LMTX methylthioninum Roche apoptosis inhibitor Alzheimer's disease/ Dementia PO InTrial 2H2018 N Y

Dexasite dexamethasone InSite Vision corticosteroid Blepharitis/ Ocular inflammation TOP InTrial 2H2018 N N RGN-259 (GBT-201; Neurotrophic keratitis (NK)/ Dry thymosin beta 4 RegeneRx actin regulating peptide TOP InTrial 2H2018 N Y RGN-352) eyes NX-1207 (NYM-4805, Benign prostatic hyperplasia fexapotide triflutate Nymox pro-apoptotic Intratumoral InTrial 2H2018 Y N REC 0482) (BPH)/ Prostate cancer BAY94-9027 Bayer anithemophilic factor Hemophilia IV InTrial 2H2018 Y N

next-generation FastTrk/ plazomicin plazomicin Achaogen/ Ionis Bacterial infections IV 2H2018 Y N aminoglycoside Breakthru tetrahydrofolate FastTrk/ iclaprim iclaprim Motif Bio Bacterial infections IV 2H2018 Y N dehydrogenase inhibitor Breakthru FastTrk/ Zeftera ceftobiprole Basilea cephalosporin antibiotic Bacterial infections IV 2H2018 Y N Breakthru calcium sensitizing Septic shock/ Heart failure/ Low FastTrk/ Simdax levosimendan Tenax Therapeutics IV 2H2018 Y N phosphodiesterase inhibitor cardiac output syndrome Breakthru polyethylene glycol-based Plenvu NER-1006 Norgine Bowel preparation PO InTrial 2H2018 N N preparation COR-003 levoketoconazole Cortendo azole antifungal Cushing's syndrome PO InTrial 2H2018 N Y Array BioPharma/ rapidly accelerated LGX-818 encorafenib Pierre Fabre Melanoma PO InTrial 2H2018 Y Y fibrosarcoma (RAF) inhibitor Medicament

cytotoxic T lymphocyte- Head and neck cancer/ Solid tremelimumab tremelimumab AstraZeneca associated antigen 4 tumors/ Mesothelioma/ Non- IV InTrial 2H2018 Y Y (CTLA4) inhibitor small cell lung cancer (NSCLC)

selective progesterone Esmya ulipristal acetate Actavis (Allergan) Uterine bleeding PO InTrial 2H2018 N N receptor modulator (SPRM) Cosmo/ Hana/ Paion/ CNS-7056 (ONO-2745) remimazolam Pharmascience/ R- benzodiazepine Procedural sedation IV InTrial 2H2018 Y N Pharm/ Yichang

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Humanwell

CoLucid/ Ill dong/ Eli neurally Acting Anti- LY-573144 (COL-144) lasmiditan Headache PO InTrial 2H2018 Y N Lilly Migraine Agent (NAAMA) Alnylam/ Ionis/ FastTrk/ ALN-TTR02 patisiran RNAi therapeutic Polyneuropathy IV 2H2018 Y Y Sanofi/ Tekmira Breakthru gamma-aminobutyric acid Fibromyalgia/ Diabetic DS-5565 mirogabalin Daiichi Sankyo PO InTrial 2H2018 N N (GABA)-ergic analog neuropathic pain (DNP) hydrocodone bitartrate/ opioid receptor agonist/ TV-46763 Teva Pain PO InTrial 2H2018 N N acetaminophen analgesic DRM-04B glycopyrronium tosylate Dermira anticholinergic Hyperhidrosis TOP InTrial 2H2018 N N

P-005672 sarecycline Allergan/ Paratek tetracyclines Acne vulgaris PO InTrial 2H2018 N N Paroxysymal nocturnal hemoglobinuria (PNH)/ ALXN-1210 ALXN-1210 Alexion C-5 monoclonal antibody IV InTrial 2H2018 Y Y Hemolytic uremic syndrome (HUS) gonadotropin-releasing FP-001 (LMIS) leuprolide mesylate Foresee Prostate cancer SC InTrial 2H2018 Y N hormone (GnRH) analog Indivior/ Reckitt RBP-7000 risperidone atypical antipsychotic Schizophrenia SC InTrial 2H2018 Y N Benckiser Zorblisa allantoin Amicus antioxidant Bacterial infections TOP Filed NDA 2H2018 Y Y sodium-dependent glucose LX-4211 sotagliflozin Sanofi/ Lexicon transporter 1 (SGLT-1) and Diabetes mellitus PO InTrial 2H2018 N N SGLT-2 inhibitor Jazz/ Aerial ADX-N05 ADX-N05 phenylalanine derivative Narcolepsy PO InTrial 3Q2018 N Y BioPharma VS-EBOV (rVSV-EBOV; Merck/ NewLink ZEBOV vaccine Ebola IM InTrial 3Q2018 Y N rVSV-ZEBOV-GP) Genetics FastTrk/ NKTR-181 NKTR-181 Nektar opioid agonist Pain PO 3Q2018 N N Breakthru RVT-101 intepirdine Avoxant 5HT-6 receptor antagonist Alzheimer's disease PO InTrial 3Q2018 N N

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date S-033188 (RG-6152) S-033188 (RG-6152) Shionogi/ Roche/ endonuclease inhibitor PO InTrial 3Q2018 N N gonadotropin-releasing Abbott/Neurocrine Endometriosis/ Menstrual NBI-56418 elagolix hormone (GnRH) receptor PO InTrial 3Q2018 N N Biosciences bleeding antagonist Chronic lymphocytic leukemia phosphatidylinositol 3 IPI-145 duvelisib AbbVie/ Infinity (CLL)/ Non-Hodgkin lymphoma PO InTrial 3Q2018 N Y kinase inhibitor (NHL) Sumitomo non-ergoline dopamine FastTrk/ APL-130277 apomorphine Dainippon/ MonoSol Parkinson's disease PO/SL 3Q2018 N N agonist Breakthru Rx/ Sunovion intraocular/ CLS-1001 triamcinolone acetonide Clearside corticosteroid Uveitis InTrial 3Q2018 Y N subretinal prostaglandin agonist/ rho latanoprost/ netarsudil Roclatan Aerie kinase-norepinephrine Glaucoma/ Ocular hypertension TOP InTrial 3Q2018 N N mesylate transport protein inhibitor HIV integrase inhibitors/ bictegravir/ emtricitabine/ nucleoside reverse Human immunodeficiency virus GS-9883/F/TAF Gilead PO InTrial 3Q2018 Y N tenofovir alafenamide transcriptase inhibitors (HIV) (NRTI)/ NRTI thrombopoietin receptor FastTrk/ S-888711 Shionogi Thrombocytopenia PO 3Q2018 Y N agonist Breakthru ArQule/ Daiichi c-Met receptor tyrosine ARQ-197 tivantinib Hepatic cancer PO InTrial 4Q2018 Y N Sankyo kinase inhibitor cholesterol ester transfer anacetrapib anacetrapib Merck Atherosclerosis/ Hyperlipidemia PO InTrial 4Q2018 N N protein (CETP) inhibitor

Remoxy oxycodone Pain Therapeutics mu-opioid receptor agonist Pain PO CRL 4Q2018 N N

Zalviso sufentanil, ARX-01 AcelRx opioid analgesic Pain SL CRL 4Q2018 Y N sphingosine 1-phosphate 1 Multiple sclerosis/ Ulcerative RPC-1063 ozanimod Receptos (S1PR1) and 5 (S1PR5) PO InTrial 4Q2018 Y N colitis (UC) receptor modulator EVK-001 metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal InTrial 4Q2018 N Y

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date angiotensin II (synthetic La Jolla renin-angiotensin peptide LJPC-501 Hypotension IV InTrial 4Q2018 Y N human) Pharmaceutical agonist dopamine receptor ALKS-3831 / samidorphan Alkermes antagonist/ opioid receptor Schizophrenia PO InTrial 4Q2018 N N antagonist Non-Hodgkin's lymphoma phosphatidylinositol-3 BAY-80-6946 copanlisib Bayer (NHL)/ Diffuse large B-cell IV/PO Filed NDA 4Q2018 Y Y kinase (PI3K) inhibitor lymphoma dexamethasone phosphate EGP-437 EyeGate corticosteroid Uveitis OP InTrial 4Q2018 Y N (iontophoretic) Short stature/ Growth hormone VRS-317 (hGH-XTEN) somavaratan Versartis/ Amunix growth hormone analog SC InTrial 4Q2018 Y Y deficiency Trevi Therapeutics/ PW-4142 (T-111) nalbuphine ER opioid agonist/ antagonist Prurigo nodularis PO InTrial 4Q2018 N N Endo Theravance Chronic obstructive pulmonary TD-4208 (GSK-1160724) revefenacin muscarinic antagonist INH InTrial 4Q2018 N N Biopharma/ disease (COPD) Attention deficit hyperactivity Sumitomo SEP-225289 dasotraline triple reuptake inhibitor disorder (ADHD)/ Eating PO InTrial 4Q2018 N N Dainippon/ Sunovion disorders intercellular adhesion Atlantic Healthcare/ AP-1007 alicaforsen molecule-1 (ICAM-1) Ulcerative colitis (UC) IV/Rectal Filed NDA 4Q2018 Y Y Ionis inhibitor FMX-101 (ARK-E021) minocycline Foamix tetracycline Acne vulgaris/ Rosacea TOP InTrial 4Q2018 N N Neurocrine catechol-O- Ongentys opicapone Biosciences/ Bial/ methyltransferase (COMT) Parkinson’s disease PO InTrial 4Q2018 N N Ono inhibitor Exocrine pancreatic liprotamase pancreatic enzyme Sollpura Eli Lilly/ Anthera insufficiency (EPI)/ Low PO CRL 4Q2018 N Y (amylase/lipase/ protease) replacement therapy digestive enzymes Sarcoma/ Diffuse large B-cell Karyopharm selective inhibitor of nuclear KPT-330 selinexor lymphoma (DLBCL)/ Acute PO InTrial 4Q2018 Y Y Therapeutics export myeloid leukemia (AML)/

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Multiple myeloma

FastTrk/ DX-2930 lanadelumab Dyax kallikrein inhibitor Hereditary angioedema (HAE) SC Late 2018 Y Y Breakthru AstraZeneca/ Array selective MEK kinase Thyroid cancer/ Uveal selumetinib selumetinib BioPharma/ Cancer PO InTrial Late 2018 Y Y inhibitor melanoma Research UK janus associated kinase 1/2 Rheumatoid arthritis/ Psoriasis/ Olumiant baricitinib Eli Lilly/ Incyte PO CRL Late 2018 Y N (JAK1/2) inhibitor Diabetic nephropathy GW FastTrk/ Sativex nabiximols Pharmaceuticals/ cannabinoid product Multiple sclerosis/ Pain SL/ SPR Late 2018 N N Breakthru Otsuka Multiple sclerosis/ Huntington's FastTrk/ Nerventra laquinimod Teva immunomodulator PO Late 2018 Y N disease Breakthru selective sphingosine-1 BAF-312 siponimod Novartis Multiple sclerosis PO InTrial Late 2018 Y N phosphate receptor agonist selective adenosine A2a tozadenant tozadenant Roche/ UCB Parkinson's disease PO InTrial Late 2018 Y N receptor antagonist Congenital myasthenic Firdapse amifampridine phosphate BioMarin/ Catalyst potassium channel blocker syndrome/ Lambert-Eaton PO CRL Late 2018 Y Y myasthenic syndrome long-acting muscarinic acetylcholine receptor AstraZeneca/ Chronic obstructive pulmonary Duaklir aclidinium/ formoterol (mAChR) antagonist/long- INH InTrial Late 2018 N N Actavis/ Circassia disease (COPD) acting beta 2 agonist (LAMA/LABA) Tetraphase fully synthetic tetracycline FastTrk/ eravacycline eravacycline Bacterial infections IV/PO Late 2018 Y N Pharmaceuticals antibiotic Breakthru moxetumomab MedImmune CD22 antigen inhibitor Hairy cell leukemia IV InTrial Late 2018 Y Y pasudotox AnGes / Mitsubishi Peripheral artery disease (PAD)/ FastTrk/ Collategene beperminogene perplasmid angiogenesis IM Late 2018 Y N Tanabe Critical Limb Ischemia (CLI) Breakthru recombinant human relaxin Reasanz serelaxin Novartis Heart failure IV InTrial Late 2018 Y N (rhRlx) agonist

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date aldoxorubicin aldoxorubicin CytRx anthracycline derivative Soft tissue sarcoma IV InTrial Late 2018 Y Y calcitonin gene-related AMG-334 erenumab Amgen Headache SC InTrial Late 2018 Y N peptide (CGRP) antagonist interleukin-13 (IL-13) Asthma/ Idiopathic pulmonary CAT-354 tralokinumab AstraZeneca SC InTrial Late 2018 Y Y inhibitor fibrosis (IPF) granulocyte colony- SPI-2012 eflapegrastim Spectrum/ Hanmi Neutropenia SC InTrial Late 2018 Y N stimulating factor (GCSF) Toll-like receptor 9 (TLR9) MGN-1703 MGN-1703 Mologen Colorectal cancer SC InTrial Late 2018 Y N agonist melanocortin type 4 PT-141 bremelanotide Palatin Female sexual disorder SC InTrial Late 2018 Y N receptor agonist FastTrk/ Brabafen fenfluramine Zogenix serotonin receptor agonist Dravet syndrome PO Late 2018 Y Y Breakthru benzhydrocodone/ Apadaz KemPharm opioid receptor agonist Pain PO CRL Late 2018 N N acetaminophen calcitonin gene-related TEV-48125 TEV-48125 Teva Headache SC InTrial Late 2018 Y N peptide (CGRP) antagonist gamma aminobutyric acid-A Seizures/ Postpartum FastTrk/ SAGE-547 allopregnanolone SAGE/ Ligand (GABA-A) receptor IV Late 2018 Y Y depression Breakthru allosteric modulator FastTrk/ Viaskin Peanut Viaskin Peanut DBV Technologies immunotherapy Peanut allergy TOP Late 2018 Y N Breakthru FastTrk/ BC-3781 lefamulin Nabriva Therapeutics pleuromutilins Bacterial infections IV/PO Late 2018 Y N Breakthru sodium-hydrogen Irritable bowel syndrome (IBS)/ RDX-5791 (AZD-1722) tenapanor Ardelyx exchanger-3 (NHE-3) PO InTrial Late 2018 N N Hyperphosphatemia inhibitor STS sodium thiosulfate Fennec reducing agent Hearing loss IV InTrial Late 2018 Y Y Myelofibrosis (MF)/ Geron/ Johnson & Myelodysplastic syndrome GRN-163L imetelstat telomerase inhibitor IV InTrial Late 2018 Y Y Johnson (MDS)/ Acute myelogenous leukemia (AML)

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date dexamethasone sustained- FastTrk/ OTO-104 Otonomy corticosteroid Meniere's disease Intratympanic Late 2018 Y N release Breakthru Ultragenyx/ Kyowa FastTrk/ KRN-23 (UX-023) burosumab fibroblast growth factor Hypophosphatemia IV/SC Late 2018 Y Y Hakko Kirin Breakthru calcitonin gene-related FastTrk/ LY-2951742 galcanezumab Eli Lilly/ Arteaus Headache SC Late 2018 Y N peptide (CGRP) antagonist Breakthru FastTrk/ PTK-0796 omadacycline Paratek aminomethylcycline Bacterial infections IV/PO Late 2018 N N Breakthru Allergy Therapeutics/ Pollinex Quattro Grass birch pollen allergen extract Vaccine Allergic rhinitis SC InTrial Late 2018 Y N Endo/ GSK/ Teva selective macrophage Pigmented Villonodular FastTrk/ PLX108-01 (PLX-3397) pexidartinib Daiichi Sankyo colony stimulating factor 1 PO Late 2018 N Y Synovitis (PVNS) Breakthru receptor inhibitor calcitonin gene-related ALD-403 eptinezumab Alder Headache IV/SC InTrial Late 2018 Y N peptide (CGRP) antagonist PRX-102 alpha galactosidase Protalix enzyme replacement Fabry's disease IV InTrial Late 2018 Y N Zavante FastTrk/ Zolyd fosfomycin cell wall inhibitor Bacterial infections IV Late 2018 Y N Therapeutics Breakthru SIGA Technologies/ FastTrk/ Arestvyr tecovirimat antiviral Smallpox IV/PO Late 2018 Y Y PharmAthene Breakthru long-acting beta 2 indacaterol/ glycopyrronium adrenergic receptor agonist QVM-149 bromide/ mometasone Novartis/ Sosei (LABA)/ long-acting Asthma INH InTrial Late 2018 N N furoate muscarinic receptor t i t (LAMA)/ Intraocular/

Subretinal/ RTH-258 brolucizumab Novartis/ Delenex anti-VEGF antibody Macular degeneration InTrial Late 2018 Y N Subconjunctiv al FMX-103 minocycline Foamix tetracycline Rosacea TOP InTrial Late 2018 N N

Dr. Reddy's DFN-02 (DFP-02) DFN-02 (DFP-02) triptan Headache Intranasal InTrial Late 2018 N N Laboratories

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Hearing loss/ Ocular Intratympanic/ FastTrk/ AM-111 brimapitide Xigen/ Auris Medical JNK stress kinase inhibitor Late 2018 Y Y inflammation Intraocular Breakthru

D-threo-methylphenidate Attention deficit hyperactivity KP-415 KemPharm CNS stimulant PO InTrial Late 2018 N N controlled-release disorder (ADHD)

Diffuse large B-cell lymphoma (DLBCL)/ Acute lymphocytic chimeric antigen receptor FastTrk/ JCAR-017 JCAR-017 Juno/ Celgene leukemia (ALL)/ Follicular IV Late 2018 Y Y (CAR) T cell therapy Breakthru lymphoma/ Mantle cell lymphoma FastTrk/ LOXO-101 larotrectinib Loxo Oncology tyrosine kinase inhibitor Solid tumors/ Sarcoma PO Late 2018 Y Y Breakthru CD-20 monoclonal Chronic lymphocytic leukemia antibody/ phosphoinositide- TG-1303 ublituximab/ TGR-1202 TG Therapeutics (CLL)/ Diffuse large B-cell IV/PO InTrial Late 2018 Y Y 3 kinase (PI3K) delta lymphoma (DLBCL) inhibitor Diffuse large B-cell lymphoma TG Therapeutics/ phosphoinositide-3 kinase TGR-1202 TGR-1202 (DLBCL)/ Chronic lymphocytic PO InTrial Late 2018 Y Y Rhizen (PI3K) delta inhibitor leukemia (CLL) FastTrk/ MSI-1256F (OHR-102) squalamine lactate Ohr angiogenesis inhibitor Macular degeneration OP Late 2018 Y N Breakthru BHV-4157 trigriluzole Portage Biotech glutamate release inhibitor Spinocerebellar ataxia PO InTrial Late 2018 Y Y

FastTrk/ RVT-802 RVT-802 Enzyvant tissue-based therapy DiGeorge syndrome Undisclosed Late 2018 Y Y Breakthru HIV-1 protease inhibitor/ Human immunodeficiency virus Tentative lopinavir/ritonavir lopinavir/ritonavir Cipla PO Late 2018 Y N CYP3A4 inhibitor (HIV) Approval poly (ADP-ribose) BMN-673 talazoparib BioMarin polymerase (PARP) Breast cancer PO InTrial Late 2018 Y N inhibitor

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date GDC-0032 (RG7604) taselisib Roche/ Chugai PI3 Kinase Inhibitor Breast cancer PO InTrial Late 2018+ Y N

interleukin-6 (IL-6) SA-237 (RG-6168) SA-237 (RG-6168) Roche/ Chugai Neuromyelitis optica (NMO) SC InTrial Late 2018+ Y Y monoclonal antibody FastTrk/ 2018 - SHP-621 budesonide Shire corticosteroid Eosinophilic esophagitis PO Y Y Breakthru 2019 2019 Possible launch date

Acute myleoid leukemia (AML)/ FastTrk/ azacitidine azacitidine Celgene DNA methylation inhibitor PO 2019 Y Y Myelodysplastic syndromes Breakthru

Clostridium difficile Clostridium difficile infection FastTrk/ ACAM-CDIFF Sanofi Pasteur vaccine IM 2019 Y N vaccine (CDI) Breakthru

ALS-8176 (ALS-008176, ALS-8176 (ALS-008176, Respiratory syncytial virus Johnson & Johnson RSV polymerase inhibitor PO InTrial 2019 N N JAL-8176) JAL-8176) (RSV) pan-fibroblast growth factor Johnson & Johnson/ JNJ-42756493 (JNJ-493) JNJ-42756493 (JNJ-493) receptor (FGFR) tyrosine Urothelial cancer PO InTrial 2019 Y N Otsuka kinase inhibitor Post-traumatic stress disorder PO/SL/ FastTrk/ TNX-102 SL cyclobenzaprine Tonix/ Vela muscle relaxant 1Q2019 N N (PTSD) Transmucosal Breakthru FibroGen/ Astellas/ hypoxia-inducible factor FG-4592 roxadustat Anemia PO InTrial Mid-2019 Y N AstraZeneca prolyl hydroxylase

Intra-Cellular Schizophrenia/ Bipolar disorder/ ITI-007 lumateperone Therapies/ Bristol- antipsychotic PO InTrial Mid-2019 N N Alzheimer's disease (AD) Myers Squibb

dopamine precursor/ dopa- ND-0612L levodopa/ carbidopa NeuroDerm Parkinson's disease (PD) SC InTrial Mid-2019 Y N decarboxylase inhibitor dopamine precursor/ dopa- ND-0612H levodopa/ carbidopa NeuroDerm Parkinson's disease (PD) SC InTrial Mid-2019 Y N decarboxylase inhibitor

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RxOutlook® 2nd Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date amyloid beta-protein MABT-5102A crenezumab Roche/ AC Immune Alzheimer's disease IV/SC InTrial 12/1/2019 Y N inhibitor Vernalis/ Tris CCP-07 CCP-07 undisclosed Cough and cold PO CRL unknown N N Pharma sodium sulfate/ potassium Tentative BC Gator Pharma osmotic laxative bowel prep Bowel preparation PO unknown N N sulfate/ magnesium sulfate Approval lamivudine / tenofovir lamivudine / tenofovir Aurobindo, Matrix Tentative disoproxil fumarate / disoproxil fumarate / NRTI / NRTI / NNRTI HIV PO unknown Y N Labs, Hetero Labs Approval nevirapine nevirapine lamivudine / tenofovir lamivudine / tenofovir Tentative Ranbaxy NRTI / NRTI HIV PO unknown Y N disoproxil fumarate disoproxil fumarate Approval Tentative atazanavir/ ritonavir atazanavir/ ritonavir Emcure protease inhibitor HIV PO unknown Y N Approval Chronic lymphocytic leukemia Eagle Tentative EP-3101 bendamustine RTD alkylating agent (CLL)/ indolent B-cell non- IV unknown Y Y Pharmaceuticals Approval Hodgkin’s lymphoma (NHL)

IM = intramuscular, INH = inhalation, INJ = injection, IUD = intrauterine device, IV = intravenous, OP = ophthalmic, PO = oral, SC = subcutaneous, SL = sublingual, SPR = spray, TOP = topical, VG = vaginal

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The information contained herein is compiled from various sources and is provided for informational purposes only. Due to factors beyond the control of OptumRx, information related to prospective drug launches is subject to change without notice. This information should not be solely relied upon for formulary decision-making purposes.

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RxOutlook® is published by the OptumRx Clinical Services Department.

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