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1 In format provided by Langer et al. (SEPTEMBER 2014) Supplementary table 1: Product examples for half-life extension / decreased dosing frequency Products based on depot formulations Parent drug Drug/carrier Indication Commercial Stage Goserelin Goserelin acetate implant / PLGA (Zoladex) Prostate cancer Approved 1989 Octreotide acetate for depot suspension / PLGA (Lupron Depot) Octreotide acetate for injectable suspension / PLGA (Sandostatin LAR) Prostate cancer; endometriosis; uterine fibroids Approved 1989 Acromegaly Approved 1998 Lanreotide Lanreotide / PLGA (Somatuline LA) Acromegaly; Thyrotropic Adenomas; Neuroendocrine Tumours Somatropin for injectable suspension / PLGA (Nutropin Depot) Growth deficiency in pediatric patients Buserelin Buserelin / PLGA (Suprefact Depot) Prostate cancer; endometriosis Approved 1998 Approved 1999; discontinued 2004 Approved 2000 Triptorelin Triptorelin / PLGA (Decapeptyl SR) Prostate cancer Approved 2000 Triptorelin pamoate Triptorelin pamoate for injectable suspension/ PLGA (Trelstar) Prostate cancer Approved 2000 acetate implant/plga(viadur ) Prostate cancer Approved 2000 BMP-7 Eptotermin alfa/collagen(osigraft) For the treatment of tibial nonunions where autograft has failed or is unfeasible BMP-2 acetate for injectable suspension/ PLGA (Eligard) rhbmp-2/acs /Collagen(INFUSE BoneGraft) Abarelix Abarelix depot for injectable suspension / carboxymethylcellulose (Plenaxis) Exenatide Exenatide extended release for injectable suspension / PLGA (Bydureon) Approved 2001 Prostate cancer Approved 2002 For use in anterior lumbar interbody spinal fusion procedures Approved 2002 Prostate cancer Approved 2003; discontinued 2006 Type 2 diabetes Approved 2012 Pasireotide Pasireotide pamoate / PLGA (Signifor) Acromegaly I SR-hGH, LB03002 / hyaluronic acid Fluid Crystal leuprolide acetate / Lipid (Prosenze, CAM2032) IFN-alpha Controlled release interferon alpha 2b/ poly (ether ester) (Locteron) IFN-alpha Medusa interferon alpha-2b XL / polyglutamate-vitamin E conjugate Interleukin-2 Medusa IL-2XL / polyglutamate-vitamin E conjugate Pediatric Growth Hormone Deficiency; Adult Growth Prostate cancer; endometriosis Renal cell carcinoma Octreotide Fluid Crystal octreotide/ Lipid (CAM2029) Acromegaly; neuroendocrine tumors I /II
2 Pegylated biopharmaceuticals Adenosine deaminase Pegademase bovine (Adagen) Severe combined immunodeficiency disease (SCID) Approved 1990 L-Asparaginase Pegaspargase (Oncaspar) Acute lymphoblastic leukemia Approved 1994 Interferon a-2b Peginterferon alfa-2b (Peg-Intron) Approved 2000 Interferon a-2b Peginterferon alfa-2b (Pegasys) Approved 2002 G-CSF Pegfilgrastim (Neulasta) Chemotherapy-induced antagonist Approved 2002 Pegvisomant (Somavert) Acromegaly Approved 2002 Erythropoietin mpeg-epoetin beta (Mircera) Anemia Approved 2007 Anti-TNF Fab Certolizumab pegol (Cimzia) Crohn s disease Approved 2008 Uricase Pegloticase (Krystexxa) Chronic gout Approved 2010 EPO mimetic peptide Peginesatide, Hematide (Omontys) G-CSF Lipegfilgrastim (Lonquex) Chemotherapy-induced Interferon b-1a Peginterferon beta-1a (Plegridy) Relapsing-remitting multiple sclerosis (RRMS) Anemia Approved 2012; discontinued 2013 Approved 2013 (in Europe) I Factor IX PEG-rFIX N9-GP Hemophilia B I Insulin Peglispro, Basal insulin lispro, BIL Type 1 and Type 2 diabetes I Consensus interferon Factor VIII Tumor necrosis factor type I Phenylalanine ammonia lyase Pegylated Recombinant Consensus Interferon Variant Solution for Injection, PEG-IFN-SA Site-specific PEGylated recombinant human factor VIII, BAY Chronic Hemophilia A I I PEG stnf-ri, Pegsunercept Rheumatoid arthritis ravpal- PEG Phenylketonuria IL-29 PEG ril-29 Anti-VEGF DARPin Abicipar pegol Macular degeneration TransCon PEG hgh, ACP-001 Pediatric Growth Hormone Deficiency; Adult Growth Uricase Pegsiticase, Uricase PEG-20 Gout Pegylated hgh, NNC Adult Growth Hormone Deficiency
3 N-glycosylation and hyper-/polysialylation Erythropoietin Darbepoetin alfa (Aranesp) Anemia Approved 2001 Erythropoietin PSA-EPO (ErepoXen) Anemia Insulin PSA-insulin (SuliXen) Diabetes Long-circulating biopharmaceuticals based on albumin Albumin Fusion Proteins GLP-1 (7-36) Albiglutide Type 2 diabetes Approved April 2014 Interferon alpha-2b Albinterferon alfa-2b (Albuferon) G-CSF Neugranin Chemotherapy-induced I; discontinued 2010* I FVIII rviii-singlechain Hemophilia A I FIX rfix-fp Hemophilia B I HER2 + HER3 specific single-chain Fv MM-111 (scfv-hsa-scfv) Cancer Albutropin, TV-1106 Pediatric Growth Extracellular EphB4 sephb4-hsa Solid tumors FVIIa rfviia-fp (CSL689) Hemophilia A or B Interferon beta Albuferon beta Multiple sclerosis Albumin binding through a conjugated fatty acid chain Insulin Insulin detemir (Levemir) Diabetes Approved 2005 Glucagon-like peptide-1 Liraglutide (Victoza) Type 2 diabetes Approved 2009 Albumin chemical conjugates Exendin-4 CJC-1134-PC Type 2 diabetes * Albuferon, the interferon alpha-2b albumin fusion, was dropped from development in 2010 despite having met I non-inferiority endpoints against Pegasys. It is not clear that immunogenicity of the fusion construct was involved, although poor tolerability compared to Pegasys was cited as a contributing factor.
4 Long-circulating biopharmaceuticals based on fusion with the IgG Fc domain TNF receptor 2 (TNFR75) Etanercept (Enbrel) Rheumatoid arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis Approved 1998 LFA-3 Alefacept (Amevive) Severe chronic plaque psoriasis Approved 2003 CTLA-4 Abatacept (Orenica) Rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis Approved 2005 IL-1R Rilonacept (Arcalyst) Cryopyrin-associated periodic syndromes Approved 2008 Thrombopoietin binding peptide VEGFR Romiplostim (NPlate) Aflibercept (Eylea); ziv-aflibercept (Zaltrap) Chronic idiopathic thrombocytopenia purpura Wet age-related macular degeneration; metastatic colorectal cancer CTLA-4 Belatacept (Nulojix) Prophylaxis of organ rejection in adults receiving a kidney transplant Approved 2008 Approved 2011, 2012 Approved 2011 Factor IX rfixfc (Alprolix) Hemophilia B Approved March 2014 Factor VIII rfviii-fc (Eloctate) Hemophilia A Approved June 2014 sil-4r Altrakincept (Nuvance) Asthma I Angiopoietin 1 and 2 binding peptide Trebananib (AMG386) Cancer (various) I B cell activating factor Blisibimod, A-623 Systemic lupus erythematosus I TNFR55 Lenercept Rheumatoid arthritis, severe sepsis I Tumor necrosis factor receptor superfamily member 13B (TACI) Atacicept Systemic lupus erythematosus; multiple sclerosis VEGFR KH902 AMD-associated choroidal neovascularization /III CD4 PRO542 HIV Activin Receptor IIA extracellular domain Soluble activin type IIB receptor Cytotoxic T-lymphocyte antigen 4 (CTLA-4) Lymphotoxic-beta receptor Activin receptor-like kinase 1 (ALK1) Recombinant P-selectin glycoprotein ligand Fibroblast growth factor receptor 1c CD95 receptor extracellular domain Sotatercept, ACE-011 Anemia ACE-031 Duchenne muscular dystrophy ASP2408 Rheumatoid arthritis Baminercept alfa, BG-9924 Dalantercept, ACE-041 Sjögren s Syndrome Rheumatoid arthritis Advanced renal cell carcinoma; advanced hepatocellular carcinoma; recurrent endometrial arcinoma YSPSL, TS-1 Ischemia reperfusion injury FP-1039, GSK Squamous non-small cell lung cancer; mesothelioma APG101 Myelodysplastic syndromes Glioblastoma
5 Long-circulating biopharmaceuticals based on alternative genetic fusion approaches Follicle stimulating Corifollitropin alfa, FSH-CTP (Elonva) - XTEN, VRS-371 Controlled Ovarian Stimulation in women participating in in vitro fertilization Pediatric Growth Approved 2010 hgh-ctp, MOD-4023 Pediatric Growth GLP-1 GLP1-ELP, PB1023 Type 2 diabetes GLP-1 Exenatide-XTEN, VRS-859 Type 2 diabetes References: 1. Jazayeri, J.A. & Carroll, G.J. in Therapeutic Proteins (Wiley-VCH Verlag GmbH & Co. KGaA, 2012). 2. Kimchi-Sarfaty, C. et al. Building better drugs: developing and regulating engineered therapeutic proteins. Trends in Pharmacological Sciences 34, (2013). 3. Kontermann, R.E. Strategies for extended serum half-life of protein therapeutics. Current Opinion in Biotechnology 22, (2011). 4. Sleep, D., Cameron, J. & Evans, L.R. Albumin as a versatile platform for drug half-life extension. Biochimica et Biophysica Acta (BBA) - General Subjects 1830,, (2013). 5. Rask-Andersen, M., Masuram, S. & Schiöth, H.B. The Druggable Genome: Evaluation of Drug Targets in Clinical Trials Suggests Major Shifts in Molecular Class and Indication. Annual Review of Pharmacology and Toxicology 54, 9-26 (2014).
RAHF PFM ALPHANINE SD COAGULATION FACTOR IX J7193 COAGULATION FACTOR IX (RFIXFC)
INFECTIOUS DISEASE ACTIMMUNE INTERFERON GAMMA 1B J9216 ADVATE RAHF PFM ONCOLOGY ORAL AFINITOR EVEROLIMUS J7527 INFECTIOUS DISEASE ALFERON N INTERFERON ALFA N3 J9215 ALPHANATE VWF J7186 ALPHANINE SD J7193
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