GSK Product development pipeline
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1 GSK Product development pipeline November 2015
2 Compound Type ndication Phase MAA NDA/BLA HV^ and nfectious Diseases dolutegravir HV integrase inhibitor + non-nucleoside + rilpivirine reverse transcriptase inhibitor HV infections - two drug maintenance regimen tafenoquine 8-aminoquinoline Plasmodium vivax malaria Relenza i.v. neuraminidase inhibitor (i.v.) influenza cabotegravir cabotegravir gepotidacin ( ) HV integrase inhibitor (long-acting parenteral formulation) HV integrase inhibitor (long-acting parenteral formulation) HV infections HV pre-exposure prophylaxis type 2 topoisomerase inhibitor bacterial infections danirixin chemokine (C-X-C Motif) receptor 2 (CXCR2) antagonist influenza* antisense oligonucleotide hepatitis B nonstructural protein 5B (NS5B) polymerase inhibitor hepatitis C antiviral maturation inhibitor HV infections Respiratory Nucala (mepolizumab) interleukin 5 (L5) monoclonal antibody severe eosinophilic asthma* Submitted S: Nov14 S: Nov14 fluticasone furoate + vilanterol + umeclidinium glucocorticoid agonist + long-acting beta2 agonist + muscarinic acetylcholine antagonist chronic obstructive pulmonary disease (COPD) mepolizumab interleukin 5 (L5) monoclonal antibody COPD* vilanterol long-acting beta2 agonist COPD muscarinic acetylcholine antagonist, beta2 agonist (MABA) COPD toll-like receptor 7 (TLR7) agonist asthma phosphatidylinositol 3-kinase delta (P3Kδ) inhibitor recombinant human angiotensin converting enzyme tumour necrosis factor receptor-1 (TNFR1) domain antibody danirixin chemokine (C-X-C Motif) receptor 2 (CXCR2) antagonist fluticasone furoate + umeclidinium glucocorticoid agonist + muscarinic acetylcholine antagonist asthma and COPD acute lung injury acute lung injury COPD* asthma COPD overlap syndrome losmapimod p38 kinase inhibitor (oral) COPD* mepolizumab interleukin 5 (L5) monoclonal antibody nasal polyposis* mepolizumab interleukin 5 (L5) monoclonal antibody hypereosinophilic syndrome (HES)* soluble epoxide hydrolase (seh) inhibitor COPD fluticasone furoate muscarinic acetylcholine antagonist, beta2 agonist (MABA) + glucocorticoid agonist COPD
3 continued Compound Type ndication Phase MAA NDA/BLA Oncology NY-ESO-1 autologous engineered TCR-T cells (engineered TCR) sarcoma, multiple myeloma, non-small cell lung cancer, melanoma and ovarian cancer tarextumab 3 notch 2/3 monoclonal antibody pancreatic and small cell lung cancer brontictuzumab 3 notch 1 monoclonal antibody solid tumours and haematological OX40 agonist monoclonal antibody solid tumours and haematological fibroblast growth factor (FGF) ligand trap mesothelioma and non-small cell lung cancer lysine-specific demethylase 1 (LSD1) inhibitor beta cell maturation antigen antibody drug conjugate erb-b2 receptor tyrosine kinase 3 (ErbB3) monoclonal antibody enhancer of zeste homologue2 (EZH2) inhibitor phosphatidylinositol 3-kinase (P3K) beta inhibitor acute myeloid leukemia and small cell lung cancer multiple myeloma solid tumours solid tumours and haematological castration resistant prostate cancer focal adhesion kinase inhibitor mesothelioma BET family bromodomain inhibitor solid tumours and haematological mmuno-inflammation sirukumab interleukin 6 (L6) human monoclonal antibody (s.c.) rheumatoid arthritis sirukumab interleukin 6 (L6) human monoclonal antibody (s.c.) giant cell arteritis antibody (s.c.) antibody (i.v.) antibody (i.v.) granulocyte macrophage colony-stimulating factor monoclonal antibody systemic lupus erythematosus* vasculitis* transplant rejection* rheumatoid arthritis oncostatin M (OSM) monoclonal antibody systemic sclerosis interleukin 7 (L7) receptor monoclonal antibody spleen tyrosine kinase (Syk) inhibitor (topical) lymphocyte activation gene 3 (LAG3) protein monoclonal antibody receptor-interacting protein 1 (RP1) kinase inhibitor chemokine (C-C motif) ligand 20 (CCL20) monoclonal antibody macrophage targeted histone deacetylase inhibitor Rare Diseases Sjogren s syndrome chronic urticaria autoimmune diseases psoriasis, rheumatoid arthritis and ulcerative colitis psoriatic arthritis rheumatoid arthritis ex-vivo stem cell gene therapy adenosine deaminase severe combined immune deficiency (ADA-SCD) Submitted S: May transthyretin (TTR) production inhibitor transthyretin-mediated amyloidosis
4 continued Compound Type ndication Phase MAA NDA/BLA Rare Diseases continued mepolizumab interleukin 5 (L5) monoclonal antibody eosinophilic granulomatosis with polyangiitis* serum amyloid P component (SAP) monoclonal antibody + SAP depleter (CPHPC) amyloidosis ex-vivo stem cell gene therapy metachromatic leukodystrophy ex-vivo stem cell gene therapy Wiscott-Aldrich syndrome ex-vivo stem cell gene therapy beta-thalassemia Vaccines Shingrix (Zoster vaccine) recombinant Herpes Zoster prophylaxis MMR live attenuated measles, mumps, rubella prophylaxis (US) N/A Ebola recombinant viral vector Ebola haemorrhagic fever prophylaxis Group B Streptococcus conjugated Group B streptococcus prophylaxis (maternal immunisation) S. pneumoniae recombinant conjugated Streptococcus pneumoniae disease next generation prophylaxis COPD recombinant non-typeable Haemophilus influenzae and Moraxella catarrhalis prophylaxis Hepatitis C recombinant viral vector hepatitis C virus prophylaxis Malaria next recombinant malaria prophylaxis generation (Plasmodium falciparum) Men ABCWY recombinant conjugated Meningococcal A,B,C,W and Y disease prophylaxis Pseudomonas 5 recombinant pseudomonas infection prophylaxis Shigella conjugated and outer membrane Shigella diarrhea prophylaxis Tuberculosis recombinant tuberculosis prophylaxis RSV recombinant respiratory syncytial virus prophylaxis (maternal immunisation) RSV replication-defective recombinant viral vector respiratory syncytial virus prophylaxis HV recombinant proteins HV infection prophylaxis Other Pharmaceuticals Metabolic retosiban oxytocin antagonist threatened pre-term labour daprodustat prolyl hydroxylase inhibitor anaemia associated with chronic renal ( ) # disease ileal bile acid transport (BAT) inhibitor cholestatic pruritus camicinal motilin receptor agonist delayed gastric emptying Eperzan/Tanzeum (albiglutide) glucagon-like peptide 1 (GLP1) receptor agonist type 1 diabetes losmapimod p38 kinase inhibitor focal segmental glomerular sclerosis* otelixizumab cluster of differentiation 3 (CD3) monoclonal antibody new onset type 1 diabetes daprodustat prolyl hydroxylase inhibitor (topical) wound healing ( ) # transient receptor potential cation channel V4 (TRPV4) antagonist heart failure selective androgen receptor modulator muscle wasting oxytocin (inhaled) oxytocin postpartum hemorrhage
5 continued Compound Type ndication Phase MAA NDA/BLA Dermatology chlorhexidine cationic polybiguanide (topical) umbilical cord care Submitted S: Oct15 Toctino (alitretinoin) retinoic acid receptor modulator chronic hand eczema N/A non-steroidal anti-inflammatory atopic dermatitis and psoriasis mepolizumab interleukin 5 (L5) monoclonal antibody severe atopic dermatitis* umeclidinium Neurosciences muscarinic acetylcholine antagonist (topical) hyperhidrosis* beta amyloid monoclonal antibody geographic retinal atrophy / Alzheimer s disease rilapladib antibody (i.v.) lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor myasthenia gravis* Alzheimer s disease KEY: n-license or other alliance relationship with third party ^ ViiV Healthcare, a global specialist HV company with GSK, Pfizer, nc. and Shionogi Limited as shareholders, is responsible for developing and delivering HV medicines. * Also being developed for indications in another therapeutic area 1 Option-based alliance with sis Pharmaceuticals 2 Option-based alliance with Adaptimmune Ltd. 3 Option-based alliance with OncoMed Pharmaceuticals 4 Option-based alliance with Telethon and Ospedale San Raffaele 5 Option-based alliance with Valneva # USAN name, NN approval pending S Month of first submission A BLA MAA NDA Phase Phase Phase Month of first regulatory approval (for MAA, this is the first EU approval letter) Biological License Application Marketing Authorisation Application (Europe) New Drug Application (USA) Evaluation of clinical pharmacology, usually conducted in volunteers Determination of dose and initial evaluation of efficacy, conducted in a small number of patients Large comparative study (compound versus placebo and/or established treatment) in patients to establish clinical benefit and safety Pending completion of the proposed divestment of GSK s rights in ofatumumab for autoimmune indications, announced 21 August 2015, ofatumumab s development programmes have been removed from this listing. MAA and NDA/BLA regulatory shown in the table above are those that have been achieved. Future filing dates are not included in this list. Brand names appearing in italics are trademarks either owned by or licensed to the GSK group of companies. Such trademarks are not approved for use by the FDA and EMA with respect to the indications referred to. This document outlines GlaxoSmithKline s drug development portfolio. The content of the drug development portfolio will change over time as new compounds progress from discovery to development and from development to the market. Owing to the nature of the drug development process, many of these compounds, especially those in early stages of investigation, may be terminated as they progress through development. For competitive reasons, new projects in pre-clinical development have not been disclosed and some project types may not have been identified. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK s operations are described under tem 3.D Risk factors in the company s Annual Report on Form 20-F for 2014.
6 Head Office and registered Office GlaxoSmithKline plc 980 Great Western Road Brentford, Middlesex TW8 9GS United kingdom Tel: +44 (0) Registered number:
GSK Product development pipeline
GSK Product development pipeline March 2015 Pipeline, products and competition Pharmaceuticals and Vaccines product development pipeline Key In-licence or other alliance relationship with third party *
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