1. No category

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
*
Also being developed for indications in another therapeutic area
S
Month of first submission
AMonth of first regulatory approval (for MAA, this is the first EU
approval letter)
BLABiological Licence Application
MAA
Marketing Authorisation Application (Europe)
NDA
New Drug Application (USA)
†
Phase I Evaluation of clinical pharmacology, usually conducted in volunteers
Phase IIDetermination of dose and initial evaluation of efficacy, conducted in a
small number of patients
Phase IIILarge comparative study (compound versus placebo and/or established
treatment) in patients to establish clinical benefit and safety
MAA and NDA/BLA regulatory review milestones shown in the table below are those that have been achieved. Future filing dates are not included in this list.
Compound
Respiratory
2126458
2256294
2862277
961081† +
fluticasone furoate
961081†
2245035
2269557
2586881†
danirixin
fluticasone furoate +
umeclidinium
losmapimod
mepolizumab
fluticasone furoate +
vilanterol†
+ umeclidinium
mepolizumab
Relvar/Breo Ellipta
(vilanterol† +
fluticasone furoate)
vilanterol†
mepolizumab
Anoro Ellipta
(umeclidinium +
vilanterol†)
Arnuity Ellipta
(fluticasone furoate)
Incruse Ellipta
(umeclidinium)
Relvar/Breo Ellipta
(vilanterol† +
fluticasone furoate)
Type
Indication
Phase
phosphoinositide 3 kinase (PI3K) inhibitor
soluble epoxide hydrolase (sEH) inhibitor
tumour necrosis factor receptor-1 (TNFR1)
domain antibody
muscarinic acetylcholine antagonist, beta2 agonist
(MABA) + glucocorticoid agonist
MABA
toll-like receptor 7 agonist
PI3K inhibitor
recombinant human angiotensin converting
enzyme 2
CXCR2 chemokine receptor antagonist
glucocorticoid agonist + muscarinic acetylcholine
antagonist
p38 kinase inhibitor (oral)
IL5 monoclonal antibody
glucocorticoid agonist + long-acting beta2
agonist + muscarinic acetylcholine antagonist
idiopathic pulmonary fibrosis
chronic obstructive pulmonary disease (COPD)
acute lung injury
I
I
I
COPD
I
COPD
asthma
asthma & COPD
acute lung injury
II
II
II
II
COPD
asthma COPD overlap syndrome
II
II
COPD*
nasal polyposis*
COPD
II
II
III
IL5 monoclonal antibody
COPD*
long-acting beta2 agonist + glucocorticoid agonist COPD – mortality outcomes
III
III
long-acting beta2 agonist
IL5 monoclonal antibody
muscarinic acetylcholine antagonist + long-acting
beta2 agonist
COPD
severe eosinophilic asthma*
COPD
III
Submitted
Approved
S: Nov14
A: May14
S: Nov14
A: Dec13
glucocorticoid agonist
asthma
Approved
N/A
A: Aug14
muscarinic acetylcholine antagonist
COPD*
Approved
A: Apr14
A:Apr14
long-acting beta2 agonist + glucocorticoid agonist asthma
Approved
A: Nov13
S: Jun14
N/A
Paediatric Vaccines
RSV
recombinant
RSV
S. pneumoniae next
generation†
MMR
Mosquirix
(Malaria RTS,S)†
DTPa-HBV-IPV/Hib†
Nimenrix
(MenACWY-TT)
Achieved regulatory
review milestones
MAA
NDA/BLA
I
recombinant viral vector
recombinant – conjugated
respiratory syncytial virus prophylaxis
(maternal immunisation)
respiratory syncytial virus prophylaxis
Streptococcus pneumoniae disease prophylaxis
live attenuated
recombinant
measles, mumps, rubella prophylaxis
malaria prophylaxis (Plasmodium falciparum)
III (US)
Submitted
N/A
S: Jun14
conjugated
diphtheria, tetanus, pertussis, poliomyelitis,
hepatitis B, haemophilus influenza
Neisseria meningitis groups A, C, W & Y
disease prophylaxis
Approved
II (US)
Approved
N/A
conjugated
I
II
A: Apr12
II (US)
GSK Product Pipline 2014
Pipeline, products and competition
continued
Pharmaceuticals and Vaccines product development pipeline continued
Compound
Type
Indication
Phase
Malaria next generation†
NTHi†
Tuberculosis†
Hepatitis C
Ebola†
recombinant
recombinant
recombinant
recombinant viral vector
recombinant viral vector
II
II
II
II
III
Zoster†
recombinant
malaria prophylaxis (Plasmodium falciparum)
non-typeable Haemophilus influenzae prophylaxis
tuberculosis prophylaxis
hepatitis C virus prophylaxis
prevention of filovirus haemorrhagic fevers caused
by Ebola Zaire virus
Herpes Zoster prophylaxis
treatment of melanoma
III
HIV integrase inhibitor
(long-acting parenteral formulation)
HIV integrase inhibitor
(long-acting parenteral formulation)
HIV integrase inhibitor +
reverse transcriptase inhibitors
(fixed dose combination)
HIV infections
II
HIV pre-exposure prophylaxis
II
HIV infections – fixed dose combination
Approved
bromodomain inhibitor
focal adhesion kinase inhibitor
PI3K inhibitor
enhancer of zeste homologue2 (EZH2)
inhibitor
ErbB3 monoclonal antibody
beta cell maturation antigen antibody
drug conjugate
lysine-specific demethylase 1 (LSD1)
inhibitor
fibroblast growth factor ligand trap
AKT protein kinase inhibitor
multi-kinase angiogenesis inhibitor +
PD-1 monoclonal antibody
AKT protein kinase inhibitor
MEK1/2 inhibitor + BRAF protein
kinase inhibitor
MEK1/2 inhibitor + BRAF protein
kinase inhibitor
MEK1/2 inhibitor + BRAF protein
kinase inhibitor + human anti-EGFR
monoclonal antibody
thrombopoietin receptor agonist
cancer
cancer
cancer
cancer
I
I
I
I
cancer
multiple myeloma
I
I
cancer
I
cancer
multiple myeloma
renal cell cancer
I
I
I
ovarian cancer
non-small cell lung cancer
II
II
rare cancers
II
colorectal cancer
II
acute myeloid leukaemia
II
CD20 human monoclonal antibody
CD20 human monoclonal antibody
MEK1/2 inhibitor + BRAF protein
kinase inhibitor
thrombopoietin receptor agonist
chronic lymphocytic leukaemia, use in relapsed patients
follicular lymphoma (refractory & relapsed patients)
metastatic melanoma, adjuvant therapy
III
III
III
myelodysplastic syndromes
III
multi-kinase angiogenesis inhibitor
CD20 human monoclonal antibody
MEK1/2 inhibitor
MEK1/2 inhibitor + BRAF protein
kinase inhibitor
thrombopoietin receptor agonist
renal cell cancer, adjuvant therapy
chronic lymphocytic leukaemia, first line therapy
metastatic melanoma
metastatic melanoma
aplastic anaemia
Other Vaccines
Antigen-Specific Cancer Immunotherapeutic
MAGE-A3
immunotherapeutic†
recombinant
HIV (ViiV Healthcare)
cabotegravir (1265744)
cabotegravir (1265744)
Triumeq (dolutegravir
+ abacavir sulphate
+ lamivudine)
Oncology
525762
2256098
2636771
2816126
2849330
2857916
2879552
3052230†
afuresertib (2110183)
Votrient (pazopanib) +
MK-3475†
afuresertib (2110183)
Mekinist (trametinib)† +
Tafinlar (dabrafenib)
Mekinist (trametinib)† +
Tafinlar (dabrafenib)
Mekinist (trametinib)† +
Tafinlar (dabrafenib) +
panitumumab†
Revolade/Promacta
(eltrombopag)†
Arzerra (ofatumumab)†
Arzerra (ofatumumab)†
Mekinist (trametinib)† +
Tafinlar (dabrafenib)
Revolade/Promacta
(eltrombopag)†
Votrient (pazopanib)
Arzerra (ofatumumab)†
Mekinist (trametinib)†
Mekinist (trametinib)† +
Tafinlar (dabrafenib)
Revolade/Promacta
(eltrombopag)†
GSK Product Pipeline 2014
Achieved regulatory
review milestones
MAA
NDA/BLA
III
A: Sep14
A: Aug14
III
Approved
Approved
Approved
A: Jun14
A: Jul14
A: Apr14
A: May13
A: Jan 14
Approved
S: Nov14
A: Aug14
Pharmaceuticals and Vaccines product development pipeline continued
Compound
Type
Indication
Phase
prolyl hydroxylase inhibitor (topical)
transient receptor potential cation
channel V4 (TRPV4) antagonist
selective androgen receptor modulator
prolyl hydroxylase inhibitor
ileal bile acid transport inhibitor
motilin receptor agonist
GLP 1 agonist
wound healing
heart failure
I
I
muscle wasting
anaemia associated with chronic renal disease
type 2 diabetes & cholestatic pruritus
delayed gastric emptying
type 1 diabetes
I
II
II
II
II
p38 kinase inhibitor
CD3 monoclonal antibody
p38 kinase inhibitor
oxytocin antagonist
GLP 1 agonist
focal segmental glomerular sclerosis*
new onset type 1 diabetes
acute coronary syndrome*
threatened pre-term labour
type 2 diabetes
II
II
III
III
Approved A: Mar14
autoimmune disease
chronic urticaria
I
I
autoimmune disease
autoimmune disease
autoimmune disease
rheumatoid arthritis
I
I
I
I
rheumatoid arthritis
II
transplant rejection*
II
systemic lupus erythematosus*
III
vasculitis*
III
rheumatoid arthritis
III
amyloidosis
I
metachromatic leukodystrophy
Wiscott-Aldrich syndrome
amyotrophic lateral sclerosis
II
II
II
III
Cardiovascular & Metabolic
1278863
2798745
2881078
1278863
2330672
camicinal
Eperzan/Tanzeum
(albiglutide)
losmapimod
otelixizumab
losmapimod
retosiban
Eperzan/Tanzeum
(albiglutide)
Immuno-inflammation
2618960
2646264
2831781†
2982772
3050002†
3117391†
3196165 (MOR103)†
Benlysta (belimumab)
Benlysta (belimumab)
Benlysta (belimumab)
sirukumab†
Rare Diseases
2398852† +
23156898†
2696274†
2696275†
ozanezumab
IL7 receptor monoclonal antibody
spleen tyrosine kinase (Syk) inhibitor
(topical)
LAG3 monoclonal antibody
RIP1 kinase inhibitor
CCL20 monoclonal antibody
macrophage targeted histone
deacetylase inhibitor
granulocyte macrophage colonystimulating factor monoclonal antibody
B lymphocyte stimulator monoclonal
antibody (i.v.)
B lymphocyte stimulator monoclonal
antibody (s.c.)
B lymphocyte stimulator monoclonal
antibody (i.v.)
IL6 human monoclonal antibody (s.c.)
2696273†
SAP monoclonal antibody +
SAP depleter (CPHPC)
ex-vivo stem cell gene therapy
ex-vivo stem cell gene therapy
neurite outgrowth inhibitor (NOGO-A)
monoclonal antibody
ex-vivo stem cell gene therapy
mepolizumab
Volibris (ambrisentan)†
IL5 monoclonal antibody (s.c.)
endothelin A antagonist
adenosine deaminase severe combined immune
deficiency (ADA-SCID)
eosinophilic granulomatosis with polyangiitis*
chronic thromboembolic pulmonary hypertension
antiviral maturation inhibitor
NS5B polymerase inhibitor
type 2 topoisomerase inhibitor
8-aminoquinoline
neuraminidase inhibitor (i.v.)
HIV infections
hepatitis C
bacterial infections
Plasmodium vivax malaria
influenza
I
I
II
III
III
CD20 human monoclonal antibody (s.c.)
B lymphocyte stimulator monoclonal
antibody (i.v.)
CD20 human monoclonal antibody (s.c.)
Lp-PLA2 inhibitor
neuromyelitis optica*
myaesthenia gravis*
II
II
multiple sclerosis*
Alzheimer's disease
II
II
Infectious Diseases
2838232
2878175
2140944
tafenoquine†
Relenza i.v. (zanamivir)†
Neurosciences
ofatumumab†
Benlysta (belimumab)
ofatumumab†
rilapladib
Achieved regulatory
review milestones
MAA
NDA/BLA
A:Apr14
III
III
GSK Product Pipeline 2014
Pipeline, products and competition
continued
Pharmaceuticals and Vaccines product development pipeline continued
Compound
Ophthalmology
933776
Dermatology
1940029
umeclidinium
2894512†
chlorhexidine
ofatumumab†
Toctino (alitretinoin)†
Type
Indication
Phase
beta amyloid monoclonal antibody
geographic retinal atrophy
II
stearoyl CoA desaturase 1 inhibitor (topical)
muscarinic acetylcholine antagonist (topical)
non-steroidal anti-inflammatory
cationic polybiguanide (topical)
CD20 human monoclonal antibody (s.c.)
retinoic acid receptor modulator
acne vulgaris
hyperhidrosis*
atopic dermatitis & psoriasis
umbilical cord care
pemphigus vulgaris*
chronic hand eczema
I
I
II
III
III
III
Achieved regulatory
review milestones
MAA
NDA/BLA
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 Research UK
ISIS Pharmaceuticals
cancer
cancer
hepatitis B
transthyretin-mediated amyloidosis
oncology
oncology
bacterial infection
I
I
I
III
I
II
I
OncoMed Pharmaceuticals
Shionogi
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.
GSK Product Pipeline 2014
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 2014.
Head Office and Registered Office
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United Kingdom
Tel: +44 (0)20 8047 5000
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www.gsk.com