RxOutlook® 1st 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 arbaclofen extended- Ontinua ER Osmotica muscle relaxant Spasticity PO Filed NDA 2017 Y N release 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 Remodulin Implantable Pulmonary arterial treprostinil United Therapeutics prostacyclin analog IV/SC Filed sNDA 2017+ Y Y System hypertension SER-120 desmopressin Allergan/Serenity antidiuretic Nocturia Intranasal Filed NDA 1Q2017 N N

Amphora Amphora Evofem spermicidal agent Pregnancy prevention VG Filed NDA 1Q2017 N N sodium glucose co- empagliflozin/ empagliflozin/ Boehringer Ingelheim transporter-2 (SGLT-2) Diabetes mellitus PO Filed NDA 1Q2017 N N metformin ER metformin ER inhibitor/biguanide promethazine/ Charleston CL-108 hydrocodone/ anti-emetic/opioid/analgesic Nausea/Vomiting/Pain PO Filed NDA 1/31/2017 N N Laboratories acetaminophen etelcalcetide Parsabiv (velcalcetide, Amgen calcimimetic Hyperparathyroidism IV Filed NDA 2/9/2017 Y N telcalcetide) Duchenne muscular MP-104 deflazacort Marathon corticosteroid PO Filed NDA 2/9/2017 Y Y dystrophy

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date ALK-Abello (HDM AIT, Abbott/ALK- Mitizax vaccine Dust mite allergic rhinitis SL Filed BLA 2/10/2017 N N MK-8237) Abello/Torii AstraZeneca/ interleukin-17 (IL-17) receptor Siliq brodalumab Psoriasis/Psoriatic arthritis SC Filed BLA 2/16/2017 Y N Valeant inhibitor naloxone naloxone Amphastar opioid antagonist Opioid dependence Intranasal Filed NDA 2/19/2017 N N tryptophan hydroxylase telotristat etiprate telotristat etiprate Lexicon Carcinoid syndrome PO Filed NDA 2/28/2017 Y Y antagonist Non-small cell lung cancer FastTrk/ MVA-MUC1-IL2 TG-4010 Transgene vaccine SC 12/1/2017 N N (NSCLC) Breakthru Xadago safinamide Newron alpha-aminoamide derivative Parkinson's disease PO Filed NDA 3/21/2017 N N

Symproic naldemedine Shionogi/Purdue opioid receptor antagonist Opioid-induced constipation PO Filed NDA 3/23/2017 N N dexamethasone Dextenza Ocular Therapeutix corticosteroid Pain/Allergic conjunctivitis OP Filed NDA 3/24/2017 N N sustained-release anti-CD20 monoclonal Ocrevus ocrelizumab Genentech Multiple sclerosis IV Filed BLA 3/28/2017 Y N antibody Atopic dermatitis (AD)/ interleukin-4/13 (IL-4/IL-13) Asthma/Sinusitis/Nasal Dupixent dupilumab Sanofi/Regeneron SC Filed BLA 3/29/2017 Y N inhibitor polyposis/Eosinophilic esophagitis Regeneron/Sanofi- anti-interleukin-6 receptor (IL- sarilumab (REGN-88) sarilumab Rheumatoid arthritis/Uveitis SC CRL 3/30/2017 Y N Aventis 6R) monoclonal antibody human parathyroid hormone- abaloparatide-SC abaloparatide-SC Radius related protein (hPTHrP) Osteoporosis SC Filed NDA 3/30/2017 Y N analog Primary immunodeficiency/ RI-002 RI-002 ADMA Biologics immunoglobulin Respiratory syncytial virus IV CRL 2Q2017 Y N (RSV)/Bacterial infections

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date AC-170 cetirizine Nicox antihistamine Allergic conjunctivitis TOP CRL 2Q2017 N N sodium zirconium ZS-9 ZS Pharma potassium-binding agent Hyperkalemia PO Filed NDA 2Q2017 N N cyclosilicate Acute lymphoblastic leukemia (ALL)/Diffuse large chimeric antigen receptor FastTrk/ CTL-019 CTL-019 Novartis B-cell lymphoma IV 2Q2017 Y Y (CAR) T cell therapy Breakthru (DLBCL)/Chronic lymphocytic leukemia (CLL) ACH-3102 (ACH- FastTrk/ odalasvir Achillion NS5A inhibitor Hepatitis C (HCV) PO 2Q2017 Y N 0143102) Breakthru N9-GP (NN-7999, NNC- 0156-0000-0009, PEG- nonacog beta pegol Novo Nordisk coagulation factor Hemophilia IV Filed BLA 2Q2017 Y Y rFIX) Bladder cancer/Non-small AstraZeneca/ cell lung cancer (NSCLC)/ durvalumab durvalumab Celgene/Eli Lilly/ anti-PDL-1 antibody IV Filed BLA 2Q2017 Y N Head and neck cancer/ Juno Therapeutics Malignant melanoma LEE-011 ribociclib Novartis/Otsuka CDK4 and CDK6 inhibitor Breast cancer PO Filed NDA 2Q2017 Y N Mantle cell lymphoma/ Indolent Non-Hodgkin lymphoma/Diffuse Large B- chimeric antigen receptor Cell Lymphoma 2Q2017 - KTE-C19 axicabtagene ciloleucel Kite IV Filed NDA Y Y (CAR) T cell therapy (DLBCL)/Chronic 4Q2017 lymphocytic leukemia (CLL)/ Small cell lymphocytic lymphoma (SLL) Huntington's disease/ vesicular monoamine Austedo deutetrabenazine Auspex Tourette's syndrome/Tardive PO Filed NDA 4/3/2017 Y Y transporter-2 (VMAT) inhibitor dyskinesia

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Immune Response Remune HIV-1 vaccine vaccine HIV IM Filed BLA 4/5/2017 Y Y BioPharma Neurocrine vesicular monoamine Tardive dyskinesia/ Ingrezza valbenazine Biosciences/ PO Filed NDA 4/11/2017 N N transporter-2 (VMAT) inhibitor Tourette's syndrome Mitsubishi Tanabe Rheumatoid janus associated kinase 1/2 baricitinib baricitinib Eli Lilly/Incyte arthritis/Psoriasis/Diabetic PO Filed NDA 4/19/2017 Y N (JAK1/2) inhibitor nephropathy CCP-07 CCP-07 Vernalis/Tris Pharma undisclosed Cough and cold PO Filed NDA 4/20/2017 N N Neuronal ceroid BMN-190 cerliponase alfa BioMarin enzyme replacement Intracerebral Filed BLA 4/27/2017 Y Y lipofuscinosis type 2 (CLN2) anaplastic lymphoma kinase Non-small cell lung cancer AP-113 (AP-26113) brigatinib ARIAD PO Filed NDA 4/29/2017 Y Y (ALK) inhibitor (NSCLC) Isentress raltegravir Merck integrase inhibitor HIV PO Filed sNDA 5/27/2017 Y N Merkel cell carcinoma (MCC)/Gastric cancers/ programed death ligand-1 Non-small cell lung cancer avelumab avelumab Merck/Pfizer IV Filed BLA 5/29/2017 Y Y (PD-L1) inhibitor (NSCLC)/Ovarian cancer/ Urothelial cancer/Renal cell carcinoma Lupus nephritis/Psoriasis/ FastTrk/ Luveniq voclosporin ILJIN calcineurin inhibitor PO Mid-2017 Y Y Transplant rejection Breakthru Major depressive disorder Travivo gepirone ER GSK/Fabre-Kramer 5-HT-1A receptor agonist PO CRL Mid-2017 N N (MDD) CM-AT, CM 4612 CM-AT, CM 4612 Curemark protein absorption enhancer Autism PO InTrial Mid-2017 Y N Bausch and nitric oxide-donating Glaucoma/Ocular Vesneo latanoprostene bunod TOP CRL Mid-2017 N N Lomb/NicOx prostaglandin F2-alpha hypetension

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RxOutlook® 1st Quarter 2017

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

human C1-esterase Berinert CSL Limited C1 inhibitor Angioedema SC Filed BLA Mid-2017 Y N inhibitor concentrate Amyotrophic lateral sclerosis Radicava edaravone Mitsubishi Tanabe free radical scavenger IV Filed NDA 6/16/2017 Y Y (ALS) Baxdela delafloxacin Melinta/Wakunaga fluoroquinolone Bacterial infections IV/PO Filed NDA 6/19/2017 Y N methylphenidate XR- Attention deficit hyperactivity Cotempla XR-ODT Neos Therapeutics CNS stimulant PO Filed NDA 6/20/2017 N N ODT disorder (ADHD) amphetamine/ Attention deficit hyperactivity SHP-465 Shire adrenergic receptor agonists PO Filed NDA 6/20/2017 N N dextroamphetamine salts disorder (ADHD) GF-00100100 ozenoxacin Medimetriks/Cipher quinolone (non-fluorinated) Bacterial infections TOP Filed NDA 6/22/2017 N N Deep vein thrombosis MK-4448 betrixaban Portola/Millennium factor Xa inhibitor (DVT)/Pulmonary embolism PO Filed NDA 6/24/2017 N N (PE) poly (ADP-ribose) polymerase Ovarian cancer/Breast niraparib niraparib Merck/TESARO PO Filed NDA 6/30/2017 Y N (PARP) inhibitor cancer TX-004HR, TX-12- estradiol TherapeuticsMD estrogen receptor agonist Vaginal atrophy Intravaginal Filed NDA 2H2017 N N 004HR long-acting muscarinic Chronic obstructive SUN-101 (EP-101) glycopyrrolate Sunovion INH Filed NDA 2H2017 N N receptor antagonist pulmonary diseaser (COPD) Fallopian tube Array MEK-162 binimetinib MEK inhibitor cancer/Melanoma/Ovarian PO Filed NDA 2H2017 Y N BioPharma/Novartis cancer/Peritoneal cancer protein kinase C-alpha (PKC- Acute myleoid leukemia PKC-412 midostaurin Novartis PO Filed NDA 2H2017 Y Y alpha) inhibitor (AML)/Mastocytosis Bristol Meyers sodium-dependent glucose SaxaDapa dapagliflozin/saxagliptin Diabetes PO CRL 2H2017 N N Squibb/AstraZeneca cotransporter 2 (SGLT-2)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date inhibitor/DPP-4 inhibitor

Tarsa/Unigene Tbria salmon calcitonin osteoclast inhibitor Osteoporosis PO Filed NDA 2H2017 N N Laboratories Zalviso sufentanil, ARX-01 AcelRx opioid analgesic Pain SL CRL 2H2017 Y N Arcion FastTrk/ clonidine (ARC-4558) clonidine Therapetuics/BioDeli alpha-2-adrenoceptor agonist Diabetic neuropathy TOP 2H2017 N N Breakthru very Sciences antibody-drug conjugate (CD- 22 mAb linked to Acute myeloid leukemia FastTrk/ inotuzumab ozogamicin inotuzumab ozogamicin Pfizer /UCB IV 2H2017 Y Y calicheamicin, a cytotoxic (AML) Breakthru agent) etirinotecan pegol Breast cancer/Colorectal FastTrk/ etirinotecan pegol Nektar topoisomerase inhibitor IV 2H2017 Y Y (NKTR-102) cancer/Ovarian cancer Breakthru Cardiorentis/ vasodilator (synthetic human FastTrk/ ularitide acetate ularitide acetate Cornerstone Heart failure IV 2H2017 Y N natriuretic peptide) Breakthru Therapeutics FastTrk/ NeuVax nelipepimut-S Galena vaccine Breast cancer intradermal 2H2017 Y N Breakthru interleukin-5 receptor (IL-5R) Asthma/Chronic obstructive benralizumab benralizumab AstraZeneca SC InTrial 2H2017 Y N alpha inhibitor pulmonary disease (COPD) Septic shock/Heart calcium sensitizing FastTrk/ Simdax levosimendan Tenax Therapeutics failure/Low cardiac output IV 2H2017 Y N phosphodiesterase inhibitor Breakthru syndrome (LCOS) APD-421 amisulpride Acacia dopamine receptor antagonist Nausea/Vomiting IV InTrial 2H2017 N N rapidly accelerated LGX-818 encorafenib Novartis Melanoma PO InTrial 2H2017 Y Y fibrosarcoma (RAF) inhibitor masitinib masitinib AB Science protein tyrosine kinase Asthma/GST/Mastocytosis/ PO InTrial 2H2017 N Y

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date inhibitor Multiple myeloma/Prostate cancer/Crohn's disease/ Multiple sclerosis/ Rheumatoid 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 converting aspirin/lisinopril/ CardiaPill CardioPharma enzyme inhibitor/HMG Co-A Cardiovascular disease PO InTrial 2H2017 N N simvastatin reductase inhibitor Schizophrenia/ LY-03004 risperidone ER Luye atypical antipsychotic IM InTrial 2H2017 Y N Schizoaffective disorder human normal IVIG-SN Green Cross immune globulin (IVIG) Primary immunodeficiency IV CRL 2H2017 Y N immunoglobulin G hydrocodone opioid receptor TV-46763 Teva Pain PO InTrial 2H2017 N N bitartrate/acetaminophen agonist/analgesic Non-small cell lung cancer FastTrk/ HM-61713 (BI-1482694) olmutinib ZAI/Hanmi kinase inhibitor PO 2H2017 Y N (NSCLC) Breakthru A-101 (V-101) hydrogen peroxide Aclaris Therapeutics peroxide Benign pigmented lesions TOP InTrial 2H2017 Y N irreversible pan-ErbB receptor neratinib neratinib Puma Biotechnology Breast cancer PO Filed NDA 2H2017 Y N tyrosine kinase inhibitor Zorblisa allantoin Scioderm antioxidant Bacterial infections TOP Filed NDA 2H2017 Y Y B-lymphocyte stimulator Systemic lupus Benlysta belimumab GlaxoSmithKline SC Filed BLA 7/2017 Y N (BLyS)-specific inhibitor erythematosus (SLE)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date HEPLISAV-B HBV vaccine Merck/Dynavax vaccine Hepatitis B (HBV) IM CRL 7/1/2017 N N Sickle beta thalessemia/ NutreStore L-glutamine Emmaus Medical amino acid PO Filed NDA 7/7/2017 N Y Sickle cell anemia epinephrine epinephrine Adamis catecholamine Emergency allergic reactions INJ Filed NDA 7/16/2017 N N anti-sclerostin monoclonal Evenity romosozumab Amgen Osteoporosis SC Filed BLA 7/19/2017 Y N antibody methylphenidate Highland Attention deficit hyperactivity Benjorna CNS stimulant PO Filed NDA 7/30/2017 N N modified-release Therapeutics disorder (ADHD) FastTrk/ tafenoquine tafenoquine GSK/MMV apoptosis modulator Malaria PO 3Q2017 N Y Breakthru 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 insulin aspart (ultra fast FIAsp Novo Nordisk fast-acting insulin Diabetes mellitus SC CRL 3Q2017 N N acting) neurokinin-1 (NK-1) receptor Varubi rolapitant Tesaro/Opko Health Nausea and vomiting IV CRL 3Q2017 Y N antagonist EUSA/Aperion/Endo/ APN-311 dinutuximab beta disialoganglioside Neuroblastoma SC InTrial 2H2017 Y Y Gen Ilac/Medison Eagle folate analog metabolic Non-small cell lung cancer EP-5101 pemetrexed IV Filed NDA 3Q2017 Y N Pharmaceuticals inhibitor (NSCLC)/Mesothelioma ARX-04 sufentanil AcelRx opioid analgesic Pain SL Filed NDA 3Q2017 Y N Breast cancer/Non-small cell FastTrk/ LY-2835219 bemaciclib (abemaciclib) Eli Lilly cyclin-dependent kinases lung cancer (NSCLC)/ PO 3Q2017 Y N Breakthru Mantle cell lymphoma SPK-RPE65 voretigene neparvovec Spark Therapeutics gene therapy Nyctalopia Intraocular Filed BLA 3Q2017 Y Y

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date QVAR BAI beclomethasone Teva corticosteroid Asthma INH InTrial 3Q2017 N N cytarabine /daunorubicin pyrimidine antimetabolite/ Acute myeloid leukemia Vyxeos Celator IV Filed NDA 2H2017 Y Y (CPX-351) anthracycline (AML) amphetamine extended- Attention deficit hyperactivity amphetamine XR-liquid Neos Therapeutics stimulant PO Filed NDA 3Q2017 N N release disorder (ADHD) ARYx Therapeutics/ vitamin K epoxide reductase ATI-5923 tecarfarin Anticoagulation PO InTrial 3Q2017 N N Armetheon enzyme inhibitor Immune thrombocytopenia fostamatinib fostamatinib Rigel oral SYK inhibitor PO InTrial 3Q2017 Y Y purpura Medidur fluocinolone acetonide Alimera/pSivida corticosteroid Posterior uveitis INJ InTrial 3Q2017 Y N urate transporter1 and Duzallo lesinurad/allopurinol AstraZeneca organic anion transporter 4 Gout PO Filed NDA 8/3/2017 N N inhibitor/hypoxanthine analog CCP-08 CCP-08 Vernalis/Tris Pharma undisclosed Viral rhinitis PO Filed NDA 8/4/2017 Y N NS5A inhibitor/nucleotide sofosbuvir/velpatasvir/ sofosbuvir/velpatasvir/ analog NS5B polymerase Gilead Hepatitis C (HCV) PO Filed NDA 8/6/2017 Y N voxilaprevir voxilaprevir inhibitor/pan-genotypic NS3 protease inhibitor NS3 protease inhibitor/NS5A ABT-493/ABT-530 glecaprevir/pibrentasvir AbbVie Hepatitis C (HCV) PO Filed NDA 8/19/2017 Y N inhibitor Dyskinesia in Parkinson's Nurelin amantadine ER Adamas antiviral PO Filed NDA 8/24/2017 N Y disease anti-rabies KamRAB Kamada /Kedrion immune globulin Rabies IM Filed BLA 8/29/2017 Y N immunoglobulin (human) Solosec secnidazole Symbiomix 5-nitroimidazole antibiotic Urinary tract infection PO Filed NDA 9/19/2017 N N

ITCA-650 (sustained exenatide sustained- Intarcia/Quintiles/ glucagon-like peptide-1 Diabetes SC implant Filed NDA 9/21/2017 N N

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date release exenatide) release Servier (GLP-1) receptor agonist

inhaled corticosteroid fluticasone fluticasone (ICS)/long-acting muscarinic Chronic obstructive furoate/umeclidinium/vila furoate/umeclidinium/ GSK/Innoviva INH Filed NDA 9/21/2017 N N agent (LAMA)/long-acting pulmonary disease (COPD) nterol vilanterol beta agonist (LABA) interleukin-6 (IL-6) sirukumab sirukumab Janssen /GSK Rheumatoid arthritis SC Filed BLA 9/2017 Y N monoclonal antibody Rexista XR oxycodone ER Intellipharmaceutics opioid agonist Pain PO Filed NDA 9/25/2017 N N phosphodiesterase-5 (PDE-5) tadalafil pharmafilm tadalafil pharmafilm MonoSol Rx Erectile dysfunction PO Filed NDA 9/28/2017 Y N inhibitor OptiNose fluticasone propionate OptiNose AS corticosteroid Nasal polyps Intranasal Filed NDA 9/30/2017 N N

ertugliflozin ertugliflozin Merck/Pfizer SGLT2 inhibitor Diabetes PO InTrial 4Q2017 N N 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 Diffuse large B-cell lymphoma (DLBCL)/ Pixuvri pixantrone Cell Therapeutics anthracycline derivative IV CRL 4Q2017 Y N Follicular lymphoma/Non- Hodgkin's lymphoma (NHL) Portola/Pfizer/Bristol- recombinant Factor Xa AndexXa andexanet alfa Reversal agent IV CRL 4Q2017 Y N Myers Squibb inhibitor antidote tildrakizumab (MK-3222) tildrakizumab (MK-3222) Merck interleukin-23 (IL-23) inhibitor Psoriasis SC InTrial 4Q2017 Y N

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Pancreatic islet reparixin reparixin Dompe interleukin-8 (IL-8) inhibitor IV InTrial 4Q2017 Y Y transplantation NX-1207 (NYM-4805, Benign prostatic hyperplasia fexapotide triflutate Nymox pro-apoptotic Intratumoral InTrial 4Q2017 Y N REC 0482) (BPH)/Prostate cancer hepatitis C FastTrk/ Civacir Biotest immunoglobulin Hepatitis C (HCV) IV 4Q2017 Y Y immunoglobulin Breakthru Zeftera ceftobiprole Basilea cephalosporin antibiotic Bacterial infections IV InTrial 4Q2017 Y N glioblastoma multiforme Northwest DCVax-L, DCVax-Brain vaccine Glioblastoma SC InTrial 4Q2017 Y Y vaccine Biotherapeutics Non-small cell lung cancer tertomotide (GV-1001) tertomotide (GV-1001) KAEL-GemVax vaccine Intradermal InTrial 4Q2017 Y N (NSCLC)/Melanoma RNA polymerase inhibitor/ rifabutin/amoxicillin/ RHB-105 RedHill Biopharma penicillin/proton pump H. pylori eradiction PO InTrial 4Q2017 N N pantoprazole inhibitor (PPI) ISIS 304801 (ISIS- Familial chylomicronemia volanesorsen Ionis antisense drug SC InTrial 4Q2017 Y Y APOCIIIRx) syndrome/Lipodystrophy Cystic fibrosis bacterial Cipro Inhale ciprofloxacin DPI Nektar/Bayer fluoroquinolone infections/Non-cystic fibrosis INH InTrial 4Q2017 N Y bronchiectasis ABX-203 ABX-203 Abivax vaccine Hepatitis B (HBV) SC/intranasal InTrial 4Q2017 N N

ITI-007 (ITI-722) ITI-007 (ITI-722) Bristol-Myers Squibb antipsychotic Schizophrenia PO 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 (OS-320) Osmotica antiviral Dyskinesia PO InTrial 4Q2017 N Y release Medicines MDL moxidectin chloride channel agonist Parasitic infections PO InTrial 4Q2017 N N Development for

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RxOutlook® 1st Quarter 2017

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

sodium glucose transporter type 2 (SGLT-2) ertugliflozin/sitagliptin ertugliflozin/sitagliptin Merck/Pfizer Diabetes PO InTrial 4Q2017 N N inhibitor/dipeptidyl peptidase- 4 (DPP-4) inhibitor AG-221 (AGI-6780; CC- isocitrate dehydrogenase 2 Acute myelogenous FastTrk/ enasidenib Celgene/Agios PO 4Q2017 Y Y 900007) inhibitor leukemia (AML)/Solid tumors Breakthru Aeroquin levofloxacin HCl Raptor fluoroquinolone Cystic fibrosis INH InTrial 4Q2017 Y Y

ertugliflozin/metformin ertugliflozin/metformin Merck/Pfizer SGLT2 inhibitor/biguanide Diabetes PO InTrial 4Q2017 N N 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) rho kinase-norepinephrine Glaucoma/Ocular Rhopressa netarsudil mesylate Aerie TOP InTrial 4Q2017 N N transport protein inhibitor hypertension mometasone controlled- RESOLVE Intersect ENT corticosteroid Sinusitis Sinus implant InTrial 4Q2017 Y N release guselkumab guselkumab Johnson & Johnson interleukin-23 (IL-23) inhibitor Psoriasis/Psoriatic arthritis SC Filed BLA 4Q2017 Y N poly (ADP-ribose) polymerase BMN-673 talazoparib BioMarin Breast cancer PO InTrial 4Q2017 Y N (PARP) inhibitor ELI-200 oxycodone/naltrexone Elite opioid agonist Pain PO CRL 4Q2017 N N Chronic lymphocytic ACP-196 acalabrutinib Acerta/Merck tyrosine kinase inhibitor leukemia (CLL)/Small cell PO InTrial 4Q2017 Y Y lymphocytic lymphoma (SLL)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date opioid receptor agonist buprenorphine/ Major depressive disorder FastTrk/ ALKS-5461 Alkermes (partial)/opioid receptor PO Late 2017 N N samidorphan (MDD) Breakthru antagonist CVT-301 levodopa Acorda antiparkinson Parkinson's disease INH InTrial Late 2017 N N 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) ISIS-TTRRx (ISIS- ISIS-TTRRx (ISIS- FastTrk/ GSK/Ionis antisense RNA modulator amyloidosis/Transthyretin SC Late 2017 Y Y 420915; GSK-2998728) 420915; GSK-2998728) Breakthru (TTR) cardiomyopathy aspartyl-alanyl Ampio Ampion diketopiperazine (DA- immunomodulator Osteoarthritis Intra-articular InTrial Late 2017 Y N Pharmaceuticals 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 IntelGenx /Red Hill VersaFilm rizatriptan triptans Headache PO CRL Late 2017 N N Biopharma Cyclacel /Daiichi Acute myeloid leukemia sapacitabine sapacitabine antimetabolite PO InTrial Late 2017 Y Y Sankyo (AML) ArQule/Daiichi c-Met receptor tyrosine ARQ-197 tivantinib Hepatic cancer PO InTrial Late 2017 Y N Sankyo kinase inhibitor Healthpoint allogeneic neonatal HP802-247 HP802-247 Venous leg ulcer TOP InTrial Late 2017 Y N Biotherapeutics keratinocytes and fibroblasts 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

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date gonadotropin-releasing Abbott/Neurocrine Endometriosis/Menstrual NBI-56418 elagolix hormone (GnRH) receptor PO InTrial Late 2017 N N Biosciences bleeding antagonist janus associated kinase Myelproliferative CYT-387 momelotinib Gilead PO InTrial Late 2017 Y Y (JAK) inhibitor disorders/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 Acute myeloid leukemia quizartinib quizartinib Ambit Biosciences PO InTrial Late 2017 Y N kinase inhibitor (AML) moxetumomab moxetumomab MedImmune CD22 antigen inhibitor Hairy cell leukemia IV InTrial Late 2017 Y Y pasudotox pasudotox 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 Gastroenteropancreatic Lutathera Tyr[3]-Octreotate (177- Accelerator somatostatin receptor agonist INJ CRL Late 2017 Y Y neuroendocrine tumors Lu-Dotatate) Applications Hepacid ADI-PEG-20 Polaris pegylated arginine deiminase Hepatic cancer IM InTrial Late 2017 Y Y Threshold FastTrk/ glufosfamide glufosfamide Pharmaceuticals/ alkylating agent Pancreatic cancer IV Late 2017 Y Y Breakthru Eleison Growth hormone somatropin somatropin Opko/Pfizer enzyme replacement deficiency/Small for SC InTrial Late 2017 Y Y gestational age (SGA)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date transmembrane activator and EMD Serono/ Systemic lupus atacicept (TACI-Ig) atacicept (TACI-Ig) CAML interactor (TACI) SC InTrial Late 2017 Y N Bristol-Myers Squibb erythematosus (SLE) receptor-immunoglobulin FastTrk/ Epidiolex cannabidiol GW Pharmaceuticals cannabinoid product Seizures PO Late 2017 Y Y Breakthru 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 polyethylene glycol-based NER-1006 NER-1006 Norgine Bowel preparation PO InTrial Late 2017 N N preparation carbapenem/beta-lactamase FastTrk/ Carbavance meropenem/RPX-7009 Medicines Company Bacterial infections IV Late 2017 N N inhibitor Breakthru VS-EBOV (rVSV-EBOV; VS-EBOV (rVSV-EBOV; Merck/NewLink vaccine Ebola IM InTrial Late 2017 Y N rVSV-ZEBOV) rVSV-ZEBOV) Genetics CNS-7056 (ONO-2745) remimazolam Paion benzodiazepine Procedural sedation IV InTrial Late 2017 Y N mycolic acid biosynthesis Deltyba delamanid Otsuka Tuberculosis PO InTrial Late 2017 N N inhibitor non-nucleoside reverse transcriptase inhibitor Human immunodeficiency rilpivirine/dolutegravir rilpivirine/dolutegravir GlaxoSmithKline/J&J PO InTrial Late 2017 Y N (NNRTI)/Integrase strand virus (HIV) transfer inhibitor (ISTI) AstraZeneca/ glucagon-like peptide-1 exenatide exenatide Alkermes/Bristol- Diabetes mellitus SC InTrial Late 2017 N N (GLP-1) receptor agonist Myers Squibb/Eli Lilly Primatene HFA epinephrine Amphastar catecholamine Asthma INH CRL Late 2017 N N Sumitomo non-ergoline dopamine FastTrk/ APL-130277 apomorphine Dainippon/MonoSol Parkinson's disease PO/SL Late 2017 N N agonist Breakthru Rx

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date ACE-910 (RG-6013, factor IXa/factor X bi-specific FastTrk/ emicizumab Roche/Chugai Hemophilia SC Late 2017 Y Y hBS-910, RO-5534262) antibody Breakthru estrogen receptor TX-001HR (TX-12- estradiol/progesterone TherapeuticsMD agonist/progesterone receptor Menopause PO InTrial Late 2017 N N 001HR) agonist Seciera (OTX-101) cyclosporine Auven Therapeutics immunosuppressant Dry eyes TOP InTrial Late 2017 Y N nucleoside reverse tenofovir disoproxyl transcriptase inhibitor (NRTI)/ Human immunodeficiency TLE-400 fumarate/lamivudine/ Mylan NRTI/non-nucleoside reverse PO InTrial Late 2017 Y N virus (HIV) efavirenz transcriptase inhibitor (NNRTI) hydroxyprogesterone Makena Lumara Health progestin Preterm labor SC InTrial Late 2017 Y Y caproate Attention deficit hyperactivity SEP-225289 (DSP- Sumitomo dasotraline triple reuptake inhibitor disorder (ADHD)/Eating PO InTrial Late 2017 N N 225289, SEP-289) Dainippon/Sunovion disorders 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 TNX-355 (TMB-355, Biogen/Roche/ Human immunodeficiency FastTrk/ ibalizumab viral entry inhibitor IM/IV/SC Late 2017 Y Y Hu-5A8) TaiMed virus (HIV) Breakthru human plasminogen human plasminogen ProMetic/Hematech plasminogen Plasminogen deficiency IV Filed BLA Late 2017 Y Y Primary biliary ursodeoxycholic acid ursodeoxycholic acid Retrophin/Asklepion bile acid derivative PO InTrial Late 2017 Y N cirrhosis/cholangitits Female Benign prostatic hyperplasia tamsulosin DRS tamsulosin DRS alpha-adrenergic antagonist PO InTrial Late 2017 N N Health/Aspen (BPH)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Intraocular/ mammalian target of Opsiria sirolimus Santen Uveitis Subretinal/PO/ InTrial Late 2017 Y Y rapamycin (mTOR) inhibitor Topical Zilretta triamcinolone acetonide Flexion corticosteroid Osteoarthritis Intra-articular Filed NDA 10/12/2017 Y N Vibex QST (QuickShot testosterone Antares androgen Hypogonadism SC Filed NDA 10/22/2017 N N Testosterone) neurokinin-1 (NK1) receptor Cinvanti aprepitant Heron Therapeutics Nausea and vomiting (N/V) IV Filed NDA 11/12/2017 N N antagonist glucagon-like peptide-1 semaglutide semaglutide Novo Nordisk Diabetes SC/PO Filed NDA 12/5/2017 Y N (GLP-1) receptor agonist

2018 Possible launch date Non-small cell lung cancer PF-00299804 dacomitinib Pfizer pan-HER inhibitor PO InTrial 2018 Y N (NSCLC) Ovarian cancer/Non- Hodgkin's lymphoma MLN-8237 alisertib Millennium aurora kinase A inhibitor (NHL)/Small cell lung cancer PO InTrial 2018 Y Y (SCLC)/Breast cancer/ Peripheral T-cell lymphoma selective endothelin-A Xinlay atrasentan AbbVie Diabetic nephropathy PO InTrial 2018 Y N receptor antagonist scyllo-cyclohexanehexol scyllo-cyclohexanehexol Transition beta-amyloid (Abeta) Alzheimer's disease/ (ELND-005, D-5, D-005, (ELND-005, D-5, D-005, PO InTrial 2018 N N Therapeutics/Perrigo oligomerization inhibitor Down's syndrome AZD-103, scylloinositol) AZD-103, scylloinositol) Niemann-Pick Disease FastTrk/ arimoclomol arimoclomol CytRx cytoprotectives (NPD)/Amyotrophic lateral PO 2018 Y Y Breakthru sclerosis (ALS) phosphatidylserine receptor Non-small cell lung cancer FastTrk/ Tarvacin bavituximab Peregrine IV 2018 Y N antagonist (NSCLC) Breakthru

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date combretastatin A4 Ovarian cancer/ vascular targeting agent FastTrk/ Zybrestat phosphate (fosbretabulin OXiGENE Neuroendocrine tumors IV 2018 Y Y (VTA) Breakthru tromethamine) (NET)/Glioma bone marrow-derived PREOB mesenchymal stem cell Bone Therapeutics stem cell therapy Fracture/Bone necrosis Intraosseus InTrial 2018 Y N therapy JNJ-56021927 (ARN- apalutamide Janssen androgen receptor antagonist Prostate cancer PO InTrial 2018 N N 509, JNJ-927) Myelofibrosis (MF)/ Geron/Johnson & Myelodysplastic syndrome GRN-163L imetelstat telomerase inhibitor IV InTrial 2018 Y Y Johnson (MDS)/Acute myelogenous leukemia (AML) DSC-127 (USB-001, aclerastide Derma Sciences angiotensin II analog Diabetic foot ulcers TOP InTrial 2018 N N NorLeu-3-A(1-7)) KAE-609 cipargamin Novartis protein synthesis inhibitor Malaria PO InTrial 2018 N N

LCI-699 osilodrostat Novartis aldosterone synthase inhibitor Cushing's syndrome PO InTrial 2018 N Y FastTrk/ TRV-130 oliceridine Trevena opioid receptor agonist Pain IV 2018 N N Breakthru beta-glucuronidase Mucopolysaccharidosis VII UX-003 (rhGUS) Ultragenyx 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 prodrug Multiple sclerosis (MS) PO InTrial 2018 Y N Chronic lymphocytic leukemia (CLL)/ CD20 antigen monoclonal MabThera rituximab Roche/Halozyme Non-Hodgkin lymphoma SC Filed BLA 2018+ Y N antibody (NHL)/Diffuse large B-cell lymphoma (DLBCL)

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date 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/Pancreatic cancer/Pancreatic cancer/ Small cell lung cancer RS7-SN-38 antibody-drug (SCLC)/ Non-small cell lung FastTrk/ IMMU-132 sacituzumab govitecan Immunomedics IV 1Q2018 Y Y conjugate cancer (NSCLC)/Colorectal Breakthru cancer/Esophageal cancer/Urinary bladder cancer Advaxis/Biocon/ ADXS-HPV (ADXS-11- Anal cancer/Cervical FusionVax/Sorrento FastTrk/ 001, Lm-LLO-E7, axalimogene filolisbac vaccine cancer/Head and neck IV 1Q2018 Y Y Therapeutics/Taiwan Breakthru lovaxin C) cancer Biotech Postherpetic neuralgia ZTlido lidocaine Scilex sodium channel blocker TOP CRL 1Q2018 N N (PHN) nonsteroidal anti- inflammatory drug KIT-302 celecoxib/amlodipine Kitov Hypertension/Osteoarthritis PO InTrial 1Q2018 N N (NSAID)/calcium channel blocker (CCB) anti-DLL3 monoclonal Small cell lung cancer Rova-T rovalpituzumab tesirine AbbVie IV InTrial 1Q2018 Y Y antibody (SCLC) IDP-118 tazarotene/halobetasol Valeant retinoid/corticosteroid Psoriasis TOP InTrial 1Q2018 N N Non-small cell lung cancer selumetinib selumetinib AstraZeneca selective MEK kinase inhibitor (NSCLC)/Thyroid PO InTrial 2Q2018 Y Y cancer/Uveal melanoma RPC-1063 ozanimod Receptos sphingosine-1-phosphate Multiple sclerosis/Ulcerative PO InTrial 2Q2018 Y N

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date receptor 1 (SP-1) modulator colitis (UC)

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 Acute myeloid leukemia anti-CD45 monoclonal- anti-CD45 monoclonal Iomab-B Actinium (AML)/Myelodysplastic IV InTrial 2Q2018 Y Y antibody BC8-I-131 antibody syndrome (MDS) Amyotrophic lateral sclerosis FastTrk/ CK-2017357 (CK-357) tirasemtiv Cytokinetics troponin activator PO 2Q2018 Y Y (ALS) Breakthru Polycythemia vera (PV)/ PharmaEssentia/AO ropeginterferon alfa-2b ropeginterferon alfa-2b interferon Myelofibrosis (MF)/Essential SC InTrial 1H2018 Y Y P Orphan thrombocythemia (ET) ethinyl hormonal combination Twirla Agile Therapeutics Pregnancy TOP CRL 1H2018 N N estradiol/levonorgestrel contraceptive prostaglandin (PG) receptor RayVa (Vitaros) alprostadil Actavis/Apricus Erectile dysfunction TOP CRL Mid-2018 N N agonist brincidofovir DNA-directed DNA Adenovirus/Cytomegalovirus FastTrk/ CMX001 hexadecyloxypropyl Chimerix PO Mid-2018 N N polymerase inhibitor (CMV) Breakthru ester FastTrk/ BAY-41-6551 amikacin Nektar/Bayer aminoglycoside Bacterial infections INH Mid-2018 Y Y Breakthru Leukocyte Interleukin Head and Neck cancer/ Multikine CEL-SCI immunomodulator SC InTrial Mid-2018 Y Y (CS-001P3) Squamous cell carcinoma synaptic vesicle protein AGB-101 levetiracetam AgeneBio Alzheimer's disease PO InTrial Mid-2018 N N modulator Shionogi/GlaxoSmith S-649266 cefiderocol cephalosporin antibiotic Bacterial infections IV InTrial Mid-2018 Y N Kiline

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date XaraColl bupivacaine implant Innocoll sodium channel blocker Pain implant CRL Mid-2018 Y N dopamine precursor/ ND-0612H levodopa/carbidopa NeuroDerm Parkinson's disease (PD) SC InTrial Mid-2018 Y N dopa-decarboxylase inhibitor Pulmonary arterial Trevyent trevyent SteadyMed prostacyclin analog SC InTrial Mid-2018 Y Y hypertension (PAH) Recro nonsteroidal anti- N-1539 meloxicam Post-surgical pain IV InTrial Mid-2018 Y N Pharma/Alkermes inflammatory drug (NSAID) opioid receptor agonist FastTrk/ CAM-2038 buprenorphine Camurus/Braeburn Opioid dependence/Pain SC Mid-2018 Y N (partial) Breakthru Shield Feraccru (ferric iron, ST- Anemia/Irritable bowel ferric trimaltol Therapeutics/AOP iron replacement PO InTrial Mid-2018 N N 10, ST10-021) syndrome (IBS) Orphan Pharma C-C chemokine receptor 5 Human immunodeficiency FastTrk/ PRO-140 PRO-140 CytoDyn IV/SC 2H2018 Y N (CCR5) antagonist virus (HIV) Breakthru MAP dihydroergotamine Semprana Pharmaceuticals/Alle dihydroergotamine Headache INH InTrial 2H2018 N N mesylate (DHE) rgan Macrilen macimorelin acetate Aeterna Zentaris ghrelin agonist Growth hormone deficiency PO CRL 2H2018 Y Y telapristone acetate Repros/Gedeon progesterone receptor Uterine fibroids/ Proellex PO InTrial 2H2018 N N (CBD4124) Richter antagonist Endometriosis Clostridium difficile- FastTrk/ cadazolid cadazolid Actelion quinolonyl-oxazolidinone PO 2H2018 N N associated diarrhea (CDAD) Breakthru Alzheimer's LMTX methylthioninum Roche apoptosis inhibitor PO InTrial 2H2018 N Y disease/Dementia Blepharitis/Ocular Dexasite dexamethasone InSite Vision corticosteroid TOP InTrial 2H2018 N N inflammation RGN-259 (GBT-201; thymosin beta 4 RegeneRx actin regulating peptide Neurotrophic keratitis TOP InTrial 2H2018 N Y

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date RGN-352) (NK)/Dry eyes

BAY94-9027 damoctocog alfa pegol Bayer anithemophilic factor Hemophilia IV InTrial 2H2018 Y N next-generation plazomicin plazomicin Achaogen/Ionis Bacterial infections IV InTrial 2H2018 Y N aminoglycoside tetrahydrofolate FastTrk/ iclaprim iclaprim Roche/Evolva SA Bacterial infections IV 2H2018 Y N dehydrogenase inhibitor Breakthru granulocyte colony- SPI-2012 SPI-2012 Spectrum Neutropenia SC InTrial 2H2018 Y N stimulating factor (GCSF) COR-003 levoketoconazole Cortendo azole antifungal Cushing's syndrome PO InTrial 2H2018 N Y Head and neck cancer/Solid cytotoxic T lymphocyte- tumors/Mesothelioma/Non- tremelimumab tremelimumab AstraZeneca associated antigen 4 (CTLA4) IV InTrial 2H2018 Y Y small cell lung cancer inhibitor (NSCLC) selective progesterone Esmya ulipristal acetate Actavis (Allergan) Uterine bleeding PO InTrial 2H2018 N N receptor modulator (SPRM) corrector ion channel ivacaftor/tezacaftor ivacaftor/tezacaftor Vertex Cystic fibrosis PO InTrial 2H2018 Y Y modulator CoLucid/Ill dong/ neurally Acting Anti-Migraine LY-573144 (COL-144) lasmiditan Headache PO InTrial 2H2018 Y N Eli Lilly Agent (NAAMA) ALN-TTR02 Alnylam/Ionis/ (GENZ438027, patisiran RNAi therapeutic Polyneuropathy IV InTrial 2H2018 Y Y Sanofi/Tekmira SAR438027) gamma-aminobutyric acid Fibromyalgia/Diabetic DS-5565 mirogabalin Daiichi Sankyo PO InTrial 2H2018 N N (GABA)-ergic analog neuropathic pain (DNP) DRM-04B DRM-04B Dermira anticholinergic Hyperhidrosis TOP InTrial 2H2018 N N

P-005672 (P-0005672, sarecycline Allergan/Paratek tetracyclines Acne vulgaris PO InTrial 2H2018 N N

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date WC-3035)

anti-CD19-CD28-zeta chimeric antigen receptor Acute lymphocytic leukemia FastTrk/ JCAR-015 modified CAR CD3+ T Juno/Celgene IV 2H2018 Y Y (CAR) T cell therapy (ALL) Breakthru lymphocyte therapy Paroxysymal nocturnal hemoglobinuria ALXN-1210 ALXN-1210 Alexion C-5 monoclonal antibody IV InTrial 2H2018 Y Y (PNH)/Hemolytic uremic syndrome (HUS) Jazz ADX-N05 (ARL-N05, ADX-N05 (ARL-N05, Pharmaceuticals/ phenylalanine derivative Narcolepsy PO InTrial 3Q2018 N Y JZP-110, SKL-N05) JZP-110, SKL-N05) Aerial BioPharma Indivior/Reckitt RBP-7000 risperidone atypical antipsychotic Schizophrenia SC InTrial 2H2018 Y N Benckiser RVT-101 (GSK-742457, intepirdine Avoxant 5HT-6 receptor antagonist Alzheimer's disease PO InTrial 3Q2018 N N SB-742457) S-033188 (RG-6152) S-033188 (RG-6152) Shionogi/Roche/ endonuclease inhibitor Influenza PO InTrial 3Q2018 N N Chronic lymphocytic phosphatidylinositol 3 kinase IPI-145 (INK-1197) duvelisib AbbVie/Infinity leukemia (CLL)/Non- PO InTrial 3Q2018 N Y inhibitor Hodgkin lymphoma (NHL) CLS-1001 (CLS-1003, intraocular/ triamcinolone acetonide Clearside corticosteroid Uveitis InTrial 3Q2018 Y N CLS-TA) subretinal prostaglandin agonist/rho latanoprost/netarsudil Glaucoma/Ocular Roclatan Aerie kinase-norepinephrine TOP InTrial 3Q2018 N N mesylate hypertension transport protein inhibitor cholesterol ester transfer Atherosclerosis/ anacetrapib anacetrapib Merck PO InTrial 4Q2018 N N protein (CETP) inhibitor Hyperlipidemia Remoxy oxycodone Pain Therapeutics mu-opioid receptor agonist Pain PO CRL 4Q2018 N N

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Major depressive disorder FastTrk/ esketamine esketamine Janssen NMDA receptor antagonist Intranasal 2018 N N (MDD) Breakthru dopamine receptor ALKS-3831 olanzapine/samidorphan Alkermes antagonist/opioid receptor Schizophrenia PO InTrial 4Q2018 N N antagonist Short stature/Growth VRS-317 (hGH-XTEN) somavaratan Versartis/Amunix growth hormone analog SC InTrial 4Q2018 Y Y hormone deficiency Trevi PW-4142 (T-111) nalbuphine ER opioid agonist/antagonist Prurigo nodularis PO InTrial 4Q2018 N N Therapeutics/Endo Theravance Chronic obstructive TD-4208 (GSK-1160724) revefenacin muscarinic antagonist INH InTrial 4Q2018 N N Biopharma/Mylan pulmonary diseaser (COPD) FMX-101 (ARK-E021) minocycline Foamix tetracyclines Acne vulgaris/Rosacea TOP InTrial 4Q2018 N N Hereditary angioedema FastTrk/ DX-2930 DX-2930 Dyax kallikrein inhibitor SC Late 2018 Y Y (HAE) Breakthru GW FastTrk/ Sativex nabiximols Pharmaceuticals/ cannabinoid product Multiple sclerosis (MS)/Pain SL/SPR Late 2018 N N Breakthru Otsuka Multiple sclerosis/ FastTrk/ Nerventra laquinimod Teva immunomodulator PO Late 2018 Y N Huntington's disease Breakthru selective adenosine A2a tozadenant tozadenant Roche/UCB Parkinson's disease PO InTrial Late 2018 Y N receptor antagonist long-acting muscarinic acetylcholine receptor Chronic obstructive aclidinium/ formoterol aclidinium/formoterol AstraZeneca/Actavis (mAChR) antagonist/long- INH InTrial Late 2018 N N pulmonary 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

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date beperminogene Peripheral artery disease AnGes/Mitsubishi FastTrk/ Collategene perplasmid angiogenesis (PAD)/Critical Limb Ischemia IM Late 2018 Y N Tanabe Breakthru (AMG-0001) (CLI) recombinant human relaxin Reasanz serelaxin (RLX-030) Novartis Heart failure IV InTrial Late 2018 Y N (rhRlx) agonist 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 Asthma/Idiopathic CAT-354 tralokinumab AstraZeneca interleukin-13 (IL-13) inhibitor SC InTrial Late 2018 Y Y pulmonary fibrosis Chronic lymphocytic leukemia (CLL)/Small cell ublituximab ublituximab TG Therapeutics CD-20 monoclonal antibody lymphocytic lymphoma IV InTrial Late 2018 Y Y (SLL)/Mantle cell lymphoma (MCL)/Multiple sclerosis Post-traumatic stress PO/SL/Transmu FastTrk/ TNX-102 SL cyclobenzaprine Tonix/Vela muscle relaxant Late 2018 N N disorder (PTSD) cosal Breakthru melanocortin type 4 receptor PT-141 bremelanotide Palatin Female sexual disorder SC InTrial Late 2018 Y N 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 sodium-dependent glucose LX-4211 sotagliflozin Sanofi/Lexicon transporter 1 (SGLT-1) and Diabetes mellitus PO InTrial 2H2018 N N SGLT-2 inhibitor

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date gamma aminobutyric acid-A Seizures/Postpartum FastTrk/ SAGE-547 allopregnanolone SAGE/Ligand (GABA-A) receptor allosteric IV Late 2018 Y Y depression Breakthru modulator FastTrk/ Viaskin Peanut Viaskin Peanut DBV Technologies immnotherapy Peanut allergy TOP Late 2018 Y N Breakthru FastTrk/ BC-3781 lefamulin Nabriva Therapeutics pleuromutilins Bacterial infections IV/PO Late 2018 Y N Breakthru STS sodium thiosulfate Fennec reducing agent Hearing loss IV InTrial Late 2018 Y Y dexamethasone FastTrk/ OTO-104 Otonomy corticosteroid Meniere's disease Intratympanic Late 2018 Y N sustained-release Breakthru FastTrk/ AR-101 (AR101) AR-101 (AR101) Aimmune peanut protein capsule Peanut allergy PO Late 2018 Y N Breakthru calcitonin gene-related FastTrk/ LY-2951742 galcanezumab Eli Lilly/Arteaus Headache SC Late 2018 Y N peptide (CGRP) antagonist Breakthru PTK-0796 (MK-2764, FastTrk/ BAY-73-7388, BAY-73- omadacycline Paratek aminomethylcyclines (AMC) Bacterial infections IV/PO Late 2018 N N Breakthru 6944) Pollinex Quattro Grass Allergy birch pollen allergen (MPL-103, Ragweed Therapeutics/Endo/ vaccine Allergic rhinitis SC InTrial Late 2018 Y N extract MATA MPL) GSK/Teva calcitonin gene-related ALD-403 ALD-403 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 SIGA Technologies/ FastTrk/ Arestvyr tecovirimat antiviral Smallpox IV/PO Late 2018 Y Y PharmAthene Breakthru indacaterol/glycopyrroniu long-acting beta 2 adrenergic QVM-149 m bromide/mometasone Novartis/Sosei receptor agonist (LABA)/long- Asthma INH InTrial Late 2018 N N furoate acting muscarinic receptor

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RxOutlook® 1st Quarter 2017

Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date antagonist (LAMA)/ corticosteroid Intraocular/ RTH-258 (ESBA-1008, brolucizumab Novartis/Delenex anti-VEGF antibody Macular degeneration Subretinal/ InTrial Late 2018 Y N DLX-1008) Subconjunctival GDC-0032 (RG7604) taselisib Roche/Chugai PI3 Kinase Inhibitor Breast cancer PO InTrial Late 2018+ Y N

FMX-103 minocycline Foamix tetracyclines Rosacea TOP InTrial Late 2018 N N Dr. Reddy's DFN-02 (DFP-02) DFN-02 (DFP-02) triptans Headache Intranasal InTrial Late 2018 N N Laboratories AM-111 (D-JNKI-1, XG- AM-111 (D-JNKI-1, XG- Hearing loss/Ocular Intratympanic/ Xigen/Auris Medical JNK stress kinase inhibitor InTrial Late 2018 Y Y 102) 102) inflammation Intraocular Attention deficity D-threo-methylphenidate KP-415 KemPharm CNS stimulant hyperactivity disorder PO InTrial Late 2018 N N controlled-release (ADHD) interleukin-6 (IL-6) SA-237 (RG-6168) SA-237 (RG-6168) Roche/Chugai Neuromyelitis optica SC InTrial Late 2018+ Y Y monoclonal antibody FastTrk/ LOXO-101 larotrectinib Loxo Oncology tyrosine kinase inhibitor Solid tumors/Sarcoma PO Late 2018 Y Y Breakthru CD-20 monoclonal Chronic lymphocytic TG-1303 ublituximab/TGR-1202 TG Therapeutics antibody/phosphoinositide-3 leukemia (CLL)/Diffuse large IV/PO InTrial Late 2018 Y Y kinase (PI3K) delta inhibitor B-cell lymphoma (DLBCL) Diffuse large B-cell TG Therapeutics/ phosphoinositide-3 kinase TGR-1202 TGR-1202 lymphoma (DLBCL)/Chronic PO InTrial Late 2018 Y Y Rhizen (PI3K) delta inhibitor lymphocytic leukemia (CLL) HIV-1 protease Human immunodeficiency Tentative lopinavir/ritonavir lopinavir/ritonavir Cipla PO Late 2018 Y N inhibitor/CYP3A4 inhibitor virus (HIV) Approval FastTrk/ 2018 - SHP-621 budesonide Shire corticosteroid Eosinophilic esophagitis PO Y Y Breakthru 2019

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RxOutlook® 1st Quarter 2017

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

2019 Possible launch date Acute myleoid leukemia FastTrk/ azacitidine azacitidine Celgene DNA methylation inhibitor (AML)/Myelodysplastic PO 2019 Y Y Breakthru syndromes Clostridium difficile Clostridium difficile infection FastTrk/ ACAM-CDIFF Sanofi Pasteur vaccine IM 2019 Y N toxoid 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 selective macrophage colony Pigmented Villonodular FastTrk/ PLX108-01 (PLX-3397) pexidartinib Daiichi Sankyo stimulating factor 1 receptor PO 2019 N Y Synovitis Breakthru inhibitor FibroGen/Astellas/ hypoxia-inducible factor prolyl FG-4592 (ASP-1517) roxadustat Anemia PO InTrial Mid-2019 Y N AstraZeneca hydroxylase (HIF-PHI) dopamine precursor/ ND-0612L levodopa/carbidopa NeuroDerm Parkinson's disease SC InTrial Mid-2019 Y N dopa-decarboxylase inhibitor Tentative atazanavir/ritonavir atazanavir/ritonavir Emcure protease inhibitor HIV PO unknown Y N Approval sodium sulfate/potassium Tentative BC Gator Pharma osmotic laxative bowel prep Bowel preparation PO unknown N N sulfate/magnesium Approval sulfate 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 Ranbaxy NRTI/NRTI HIV PO Tentative unknown Y N

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RxOutlook® 1st Quarter 2017

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

Chronic lymphocytic Eagle leukemia (CLL)/indolent Tentative EP-3101 bendamustine RTD alkylating agent IV unknown Y Y Pharmaceuticals B-cell non-Hodgkin’s Approval 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, NSCLC = Non-small cell lung cancer

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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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All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx.

RxOutlook® is published by the OptumRx Clinical Services Department.

© 2017 Optum, Inc. All rights reserved. ORX6204A_160128

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