GSK Product development pipeline
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1 GSK Product development pipeline March 2015
2 Pipeline, products and competition Pharmaceuticals and Vaccines product development pipeline Key In-licence or other alliance relationship with third party * Also being developed for indications in another therapeutic area S Month of first submission A Month of first regulatory approval (for MAA, this is the first EU approval letter) BLA Biological Licence Application MAA Marketing Authorisation Application (Europe) NDA New Drug Application (USA) Phase I Evaluation of clinical pharmacology, usually conducted in volunteers Phase II Determination of dose and initial evaluation of efficacy, conducted in a small number of patients Phase III Large comparative study (compound versus placebo and/or established treatment) in patients to establish clinical benefit and safety MAA and NDA/BLA regulatory shown in the table below are those that have been achieved. Future filing dates are not included in this list. Respiratory phosphoinositide 3 kinase (PI3K) inhibitor idiopathic pulmonary fibrosis I soluble epoxide hydrolase (seh) inhibitor chronic obstructive pulmonary disease (COPD) I tumour necrosis factor receptor-1 (TNFR1) acute lung injury I domain antibody muscarinic acetylcholine antagonist, beta2 agonist COPD I fluticasone furoate (MABA) + glucocorticoid agonist MABA COPD II toll-like receptor 7 agonist asthma II PI3K inhibitor asthma & COPD II recombinant human angiotensin converting acute lung injury II enzyme 2 danirixin CXCR2 chemokine receptor antagonist COPD II fluticasone furoate + glucocorticoid agonist + muscarinic acetylcholine asthma COPD overlap syndrome II umeclidinium antagonist losmapimod p38 kinase inhibitor (oral) COPD* II mepolizumab IL5 monoclonal antibody nasal polyposis* II fluticasone furoate + glucocorticoid agonist + long-acting beta2 COPD III vilanterol agonist + muscarinic acetylcholine antagonist + umeclidinium mepolizumab IL5 monoclonal antibody COPD* III Relvar/Breo Ellipta long-acting beta2 agonist + glucocorticoid agonist COPD mortality outcomes III (vilanterol + fluticasone furoate) vilanterol long-acting beta2 agonist COPD III mepolizumab IL5 monoclonal antibody severe eosinophilic asthma* Submitted S: Nov14 S: Nov14 Anoro Ellipta muscarinic acetylcholine antagonist + long-acting COPD Approved A: May14 A: Dec13 (umeclidinium + beta2 agonist vilanterol ) Arnuity Ellipta glucocorticoid agonist asthma Approved N/A A: Aug14 (fluticasone furoate) Incruse Ellipta muscarinic acetylcholine antagonist COPD* Approved A: Apr14 A:Apr14 (umeclidinium) Relvar/Breo Ellipta long-acting beta2 agonist + glucocorticoid agonist asthma Approved A: Nov13 S: Jun14 (vilanterol + fluticasone furoate) Paediatric Vaccines RSV recombinant respiratory syncytial virus prophylaxis I (maternal immunisation) RSV recombinant viral vector respiratory syncytial virus prophylaxis I S. pneumoniae next recombinant conjugated Streptococcus pneumoniae disease prophylaxis II generation MMR live attenuated measles, mumps, rubella prophylaxis III (US) N/A Mosquirix recombinant malaria prophylaxis (Plasmodium falciparum) Submitted S: Jun14 N/A (Malaria RTS,S) DTPa-HBV-IPV/Hib conjugated diphtheria, tetanus, pertussis, poliomyelitis, Approved N/A hepatitis B, haemophilus influenza II (US) Nimenrix conjugated Neisseria meningitis groups A, C, W & Y Approved A: Apr12 (MenACWY-TT) disease prophylaxis II (US) GSK Product Pipline 2014
3 Pipeline, products and competition continued Pharmaceuticals and Vaccines product development pipeline continued Other Vaccines Malaria next generation recombinant malaria prophylaxis (Plasmodium falciparum) II NTHi recombinant non-typeable Haemophilus influenzae prophylaxis II Tuberculosis recombinant tuberculosis prophylaxis II Hepatitis C recombinant viral vector hepatitis C virus prophylaxis II Ebola recombinant viral vector prevention of filovirus haemorrhagic fevers caused III by Ebola Zaire virus Zoster recombinant Herpes Zoster prophylaxis III Antigen-Specific Cancer Immunotherapeutic MAGE-A3 recombinant treatment of melanoma III immunotherapeutic HIV (ViiV Healthcare) cabotegravir ( ) HIV integrase inhibitor HIV infections II (long-acting parenteral formulation) cabotegravir ( ) HIV integrase inhibitor HIV pre-exposure prophylaxis II (long-acting parenteral formulation) Triumeq (dolutegravir HIV integrase inhibitor + HIV infections fixed dose combination Approved A: Sep14 A: Aug14 + abacavir sulphate reverse transcriptase inhibitors + lamivudine) (fixed dose combination) Oncology bromodomain inhibitor cancer I focal adhesion kinase inhibitor cancer I PI3K inhibitor cancer I enhancer of zeste homologue2 (EZH2) cancer I inhibitor ErbB3 monoclonal antibody cancer I beta cell maturation antigen antibody multiple myeloma I drug conjugate lysine-specific demethylase 1 (LSD1) cancer I inhibitor fibroblast growth factor ligand trap cancer I afuresertib ( ) AKT protein kinase inhibitor multiple myeloma I Votrient (pazopanib) + multi-kinase angiogenesis inhibitor + renal cell cancer I MK-3475 PD-1 monoclonal antibody afuresertib ( ) AKT protein kinase inhibitor ovarian cancer II Mekinist (trametinib) + MEK1/2 inhibitor + BRAF protein non-small cell lung cancer II Mekinist (trametinib) + MEK1/2 inhibitor + BRAF protein rare cancers II Mekinist (trametinib) + MEK1/2 inhibitor + BRAF protein colorectal cancer II Tafinlar (dabrafenib) + kinase inhibitor + human anti-egfr panitumumab monoclonal antibody Revolade/Promacta thrombopoietin receptor agonist acute myeloid leukaemia II (eltrombopag) Arzerra (ofatumumab) CD20 human monoclonal antibody chronic lymphocytic leukaemia, use in relapsed patients III Arzerra (ofatumumab) CD20 human monoclonal antibody follicular lymphoma (refractory & relapsed patients) III Mekinist (trametinib) + MEK1/2 inhibitor + BRAF protein metastatic melanoma, adjuvant therapy III Revolade/Promacta thrombopoietin receptor agonist myelodysplastic syndromes III (eltrombopag) Votrient (pazopanib) multi-kinase angiogenesis inhibitor renal cell cancer, adjuvant therapy III Arzerra (ofatumumab) CD20 human monoclonal antibody chronic lymphocytic leukaemia, first line therapy Approved A: Jun14 A: Apr14 Mekinist (trametinib) MEK1/2 inhibitor metastatic melanoma Approved A: Jul14 A: May13 Mekinist (trametinib) + MEK1/2 inhibitor + BRAF protein metastatic melanoma Approved A: Jan 14 Revolade/Promacta thrombopoietin receptor agonist aplastic anaemia Approved S: Nov14 A: Aug14 (eltrombopag) GSK Product Pipeline 2014
4 Pharmaceuticals and Vaccines product development pipeline continued Cardiovascular & Metabolic prolyl hydroxylase inhibitor (topical) wound healing I transient receptor potential cation heart failure I channel V4 (TRPV4) antagonist selective androgen receptor modulator muscle wasting I prolyl hydroxylase inhibitor anaemia associated with chronic renal disease II ileal bile acid transport inhibitor type 2 diabetes & cholestatic pruritus II camicinal motilin receptor agonist delayed gastric emptying II Eperzan/Tanzeum GLP 1 agonist type 1 diabetes II (albiglutide) losmapimod p38 kinase inhibitor focal segmental glomerular sclerosis* II otelixizumab CD3 monoclonal antibody new onset type 1 diabetes II losmapimod p38 kinase inhibitor acute coronary syndrome* III retosiban oxytocin antagonist threatened pre-term labour III Eperzan/Tanzeum GLP 1 agonist type 2 diabetes Approved A: Mar14 A:Apr14 (albiglutide) Immuno-inflammation IL7 receptor monoclonal antibody autoimmune disease I spleen tyrosine kinase (Syk) inhibitor chronic urticaria I (topical) LAG3 monoclonal antibody autoimmune disease I RIP1 kinase inhibitor autoimmune disease I CCL20 monoclonal antibody autoimmune disease I macrophage targeted histone rheumatoid arthritis I deacetylase inhibitor (MOR103) granulocyte macrophage colony- rheumatoid arthritis II stimulating factor monoclonal antibody Benlysta (belimumab) B lymphocyte stimulator monoclonal transplant rejection* II antibody (i.v.) Benlysta (belimumab) B lymphocyte stimulator monoclonal systemic lupus erythematosus* III antibody (s.c.) Benlysta (belimumab) B lymphocyte stimulator monoclonal vasculitis* III antibody (i.v.) sirukumab IL6 human monoclonal antibody (s.c.) rheumatoid arthritis III Rare Diseases SAP monoclonal antibody + amyloidosis I SAP depleter (CPHPC) ex-vivo stem cell gene therapy metachromatic leukodystrophy II ex-vivo stem cell gene therapy Wiscott-Aldrich syndrome II ozanezumab neurite outgrowth inhibitor (NOGO-A) amyotrophic lateral sclerosis II monoclonal antibody ex-vivo stem cell gene therapy adenosine deaminase severe combined immune III deficiency (ADA-SCID) mepolizumab IL5 monoclonal antibody (s.c.) eosinophilic granulomatosis with polyangiitis* III Volibris (ambrisentan) endothelin A antagonist chronic thromboembolic pulmonary hypertension III Infectious Diseases antiviral maturation inhibitor HIV infections I NS5B polymerase inhibitor hepatitis C I type 2 topoisomerase inhibitor bacterial infections II tafenoquine 8-aminoquinoline Plasmodium vivax malaria III Relenza i.v. (zanamivir) neuraminidase inhibitor (i.v.) influenza III Neurosciences ofatumumab CD20 human monoclonal antibody (s.c.) neuromyelitis optica* II Benlysta (belimumab) B lymphocyte stimulator monoclonal myaesthenia gravis* II antibody (i.v.) ofatumumab CD20 human monoclonal antibody (s.c.) multiple sclerosis* II rilapladib Lp-PLA2 inhibitor Alzheimer's disease II GSK Product Pipeline 2014
5 Pipeline, products and competition continued Pharmaceuticals and Vaccines product development pipeline continued Ophthalmology beta amyloid monoclonal antibody geographic retinal atrophy II Dermatology stearoyl CoA desaturase 1 inhibitor (topical) acne vulgaris I umeclidinium muscarinic acetylcholine antagonist (topical) hyperhidrosis* I non-steroidal anti-inflammatory atopic dermatitis & psoriasis II chlorhexidine cationic polybiguanide (topical) umbilical cord care III ofatumumab CD20 human monoclonal antibody (s.c.) pemphigus vulgaris* III Toctino (alitretinoin) retinoic acid receptor modulator chronic hand eczema III N/A Brand names appearing in italics are trade marks either owned by and/or licensed to GSK or associated companies. Option-based alliances with third parties that include assets in phase I and phase III development: Company Disease Area Phase Adaptimmune cancer I Cancer Research UK cancer I ISIS Pharmaceuticals hepatitis B transthyretin-mediated amyloidosis I III OncoMed Pharmaceuticals oncology I oncology II Shionogi bacterial infection I 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 Item 3.D Risk factors in the company s Annual Report on Form 20-F for GSK Product Pipeline 2014
6 Head Office and Registered Office GlaxoSmithKline plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom Tel: +44 (0) Registered number:
GSK Product development pipeline
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