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February 2009

Product Development Pipeline


Product Development Pipeline February 2009
Therapeutic area Compound/Vaccine Type Indication Phase Estimated
submission dates
MAA NDA/BLA
Biopharmaceuticals 249320 monoclonal antibody stroke I
933776 monoclonal antibody Alzheimer’s disease I
iboctadekin† + Doxil IL18 immunomodulator + topoisomerase ll ovarian cancer l
inhibitor
iboctadekin† + rituximab IL18 immunomodulator + anti-CD20 non-Hodgkin’s lymphoma l
monoclonal antibody
315234 monoclonal antibody rheumatoid arthritis ll
679586 monoclonal antibody severe asthma ll
belimumab† anti-B lymphocyte stimulator monoclonal systemic lupus erythematosus Il
antibody (s.c.)
mepolizumab anti-IL5 monoclonal antibody severe asthma & nasal polyposis ll
ofatumumab† anti-CD20 human monoclonal antibody diffuse large B cell lymphoma II
ofatumumab† anti-CD20 human monoclonal antibody multiple sclerosis II
belimumab† anti-B lymphocyte stimulator monoclonal systemic lupus erythematosus III
antibody (i.v.)
ofatumumab† anti-CD20 human monoclonal antibody follicular lymphoma lll
ofatumumab† anti-CD20 human monoclonal antibody rheumatoid arthritis lll
otelixizumab† anti-CD3 monoclonal antibody type 1 diabetes lll
Syncria† glucagon-like peptide 1 agonist type 2 diabetes lll
Bosatria (mepolizumab) anti-IL5 monoclonal antibody hypereosinophilic syndrome Submitted S:Sep08
ofatumumab† anti-CD20 human monoclonal antibody refractory chronic lymphocytic leukaemia Submitted S:Feb09 S:Jan09
Cardiovascular 256073 high affinity nicotinic acid receptor dyslipidaemia I
& Metabolic (HM74A) agonist
1278863 prolyl hydroxylase inhibitor anaemia I
1292263 gastrin-releasing peptide (GRP) receptor agonist type 2 diabetes l
1521498 mu-opioid receptor inverse agonist obesity l
1614235† sodium dependent glucose transport (SGLT1) type 2 diabetes l
inhibitor
2245840 SIRT1 activator type 2 diabetes (also chronic obstructive pulmonary disease, l
COPD)
221149 oxytocin antagonist threatened pre-term labour ll
756050 bile acid receptor agonist type 2 diabetes ll
184072 SIRT1 activator type 2 diabetes (also oncology indications) ll
Iosmapimod (856553) p38 kinase inhibitor cardiovascular disease (also COPD & depression) ll
pazopanib multi-kinase angiogenesis inhibitor (eye drops) age-related macular degeneration (also cancer indications) ll
remogliflozin etabonate† SGLT2 inhibitor type 1 diabetes ll
remogliflozin etabonate† SGLT2 inhibitor type 2 diabetes ll
rilapladib† Lp-PLA2 inhibitor atherosclerosis ll
ronacaleret† calcium antagonist osteoporosis & fracture healing ll
Avandamet XR PPAR gamma agonist + metformin type 2 diabetes – extended release lll N/A
Avandia + simvastatin PPAR gamma agonist + statin type 2 diabetes lll N/A
darapladib† Lp-PLA2 inhibitor atherosclerosis III
Arixtra synthetic factor Xa inhibitor treatment of acute coronary syndrome Approved A:Aug07 AL:Feb07
& Sep07
Avandia PPAR gamma agonist prevention of disease progression Approved S:Nov08 A:Jul08
Volibris† endothelin A antagonist pulmonary arterial hypertension Approved A:Apr08 N/A
Infectious Diseases 932121 plasmodium electron transport chain inhibitor malaria l
945237 topoisomerase ll inhibitor treatment of bacterial infections l
1265744† HIV integrase inhibitor HIV infections l
1322322 novel class antibacterial agent treatment of bacterial infections l
1349572† HIV integrase inhibitor HIV infections ll
IDX899† non-nucleotide reverse transcriptase inhibitor HIV infections ll
sitamaquine 8-aminoquinoline treatment of visceral leishmaniasis II N/A
tafenoquine† 8-aminoquinoline Plasmodium vivax malaria II
Neurosciences 163090 5HT1 antagonist depression & anxiety I
424887 NK1 antagonist/SSRI depression & anxiety l
586529† CRF1 antagonist depression & anxiety l
598809 dopamine D3 antagonist drug dependency I
618334 dopamine D3 antagonist drug dependency l
729327 AMPA receptor modulator schizophrenia I
1014802 sodium channel blocker bipolar disorder l
1018921 type 1 glycine transport inhibitor schizophrenia l
1034702 muscarinic acetylcholine agonist dementia l
1144814 NK1/NK3 antagonist schizophrenia l
1482160 purinergic ATP receptor antagonist pain l
orvepitant NK1 antagonist depression & anxiety l
239512 histamine H3 antagonist dementia ll
468816 glycine antagonist smoking cessation II
561679† CRF1 antagonist depression & anxiety Il
649868† orexin antagonist sleep disorders II
681323 p38 kinase inhibitor neuropathic pain II
742457 5HT6 antagonist dementia ll
firategrast† dual alpha4 integrin antagonist (VLA4) multiple sclerosis II
losmapimod (856553) p38 kinase inhibitor depression (also cardiovascular disease & COPD) ll
Solzira (1838262)† voltage-gated calcium channel modulator migraine prophylaxis ll
Solzira (1838262)† voltage-gated calcium channel modulator neuropathic pain ll
almorexant† orexin antagonist insomnia lll
Lamictal XR sodium channel inhibitor epilepsy – partial generalised tonic-clonic seizures, once-daily III N/A 2009
retigabine† neuronal potassium channel opener epilepsy – partial seizures lll
rosiglitazone XR PPAR gamma agonist Alzheimer's disease III
Lunivia† non-benzodiazepine GABA agonist insomnia Submitted PO:Oct08 N/A
Solzira (1838262)† voltage-gated calcium channel modulator restless legs syndrome Submitted S:Sep08 &
Jan09
Lamictal XR sodium channel inhibitor epilepsy – partial seizures, once-daily Approvable N/A AL: Sep07
Requip Modutab/XL† non-ergot dopamine agonist Parkinson’s disease – once-daily controlled release Approved A:Mar07 A:Jun08
formulation
Treximet† 5HT1 agonist + naproxen migraine – fixed dose combination Approved N/A A:Apr08
Oncology 461364 polo-like kinase inhibitor cancer l
923295† centromere-associated protein E (CENP-E) cancer l
inhibitor
1120212† mitogen-activated protein kinase inhibitor cancer l
(MEK1/2)
totrombopag† thrombopoietin receptor agonist thrombocytopaenia I
184072 SIRT1 activator colon & haematologic cancers (also type 2 diabetes) ll
1363089† mesenchymal-epithelial transition factor (C-met) papillary renal cell carcinoma, gastric cancer and head & neck ll
kinase inhibitor squamous cell carcinoma
pazopanib multi-kinase angiogenesis inhibitor non-small cell lung cancer ll
pazopanib multi-kinase angiogenesis inhibitor ovarian cancer ll
pazopanib + Tyverb/Tykerb multi-kinase angiogenesis inhibitor + Her2 metastatic breast cancer II
and epidermal growth factor receptor (EGFR)
dual kinase inhibitor
Revolade/Promacta† thrombopoietin receptor agonist oncology-related thrombocytopaenia II
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (unresectable disease) ll
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory inflammatory breast cancer ll
Avodart 5-alpha reductase inhibitor reduction in the risk of prostate cancer lll 2009 2009
elesclomol† oxidative stress inducer metastatic melanoma lll
pazopanib multi-kinase angiogenesis inhibitor sarcoma lll
pazopanib + Tyverb/Tykerb multi-kinase angiogenesis inhibitor + Her2 and inflammatory breast cancer lll
EGFR dual kinase inhibitor
Revolade/Promacta† thrombopoietin receptor agonist chronic liver disease induced thrombocytopaenia lll
Revolade/Promacta† thrombopoietin receptor agonist hepatitis C induced thrombocytopaenia lll
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, adjuvant therapy lll
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, first line therapy lll 2009 2009
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor gastric cancer lll
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (resectable disease) lll
Duodart (Avodart + 5-alpha reductase inhibitor + alpha blocker benign prostatic hyperplasia – fixed dose combination Submitted S:Dec08 2009
alpha blocker)
pazopanib multi-kinase angiogenesis inhibitor renal cell cancer (also age-related macular degeneration) Submitted S:Feb09 S:Dec08
Zunrisa/Rezonic NK1 antagonist chemotherapy-induced & postoperative nausea & vomiting Submitted S:Jul08 S:May08
Hycamtin topoisomerase l inhibitor (oral) small cell lung cancer, second-line therapy Approved A:Mar08 A:Oct07
Revolade/Promacta† thrombopoietin receptor agonist idiopathic thrombocytopaenic purpura Approved S:Dec08 A:Nov08
Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory breast cancer Approved A:Jun08 A:Mar07
Respiratory & 610677 p38 kinase inhibitor (inhaled) COPD l
Immuno- 656933 Chemokine receptor (CXCR2) antagonist cystic fibrosis & COPD l
inflammation 705498 transient receptor potential vanilloid (TRPV1) non-allergic rhinitis l
antagonist (intranasal)
962040 motilin receptor agonist delayed gastric emptying l
1399686 anti-inflammatory macrolide conjugate (oral)
inflammatory bowel disease l
2245840 SIRT1 activator COPD (also type 2 diabetes) l
159797† long-acting beta2 agonist COPD, also COPD & asthma in combination with a II
glucocorticoid agonist
159802† long-acting beta2 agonist COPD, also COPD & asthma in combination with a II
glucocorticoid agonist
256066 PDE IV inhibitor (inhaled) asthma & COPD Il
573719 muscarinic acetylcholine antagonist COPD Il
685698 glucocorticoid agonist asthma, also COPD & asthma in combination with a II
long-acting beta2 agonist
835726 histamine H1/H3 dual antagonist (oral) allergic rhinitis ll
870086 novel glucocorticoid agonist (inhaled) asthma ll
642444† long-acting beta2 agonist COPD, also COPD & asthma in combination with a ll
glucocorticoid agonist
961081† muscarinic antagonist, beta2 agonist COPD ll
1004723 histamine H1/H3 dual antagonist (intranasal) allergic rhinitis ll
2190915† 5-lipoxygenase-activating protein (FLAP) inhibitor asthma ll
darotropium muscarinic acetylcholine antagonist COPD ll
darotropium + 642444† muscarinic acetylcholine antagonist + COPD ll
long-acting beta2 agonist
losmapimod (856553) p38 kinase inhibitor (oral) COPD (also cardiovascular disease & depression) ll
Entereg† peripheral mu-opioid antagonist post operative ileus Approved N/A A:May08
Paediatric Vaccines Mosquirix recombinant malaria prophylaxis ll
Hib-MenCY-TT conjugated Neisseria meningitis groups C & Y disease & III 2009
Haemophilus influenzae type b disease prophylaxis
MenACWY-TT conjugated Neisseria meningitis groups A, C, W & Y disease prophylaxis IIl
Synflorix conjugated Streptococcus pneumoniae disease prophylaxis in infants Submitted PO:Jan09
& children
Kinrix subunit – inactivated diphtheria, tetanus, pertussis and poliomyelitis prophylaxis Approved A:Jun08
(booster – 5th dose)
Rotarix† live attenuated (oral) rotavirus-induced gastroenteritis prophylaxis Approved A:Feb06 A:Apr08
Other Vaccines Cytomegalovirus recombinant cytomegalovirus infection prophylaxis l
HIV recombinant HIV infection prophylaxis l
NTHi-Pneumo recombinant Streptococcus pneumoniae and Haemophilus influenzae l
disease prophylaxis in adults
S. pneumoniae adult recombinant – conjugated Streptococcus pneumoniae disease prophylaxis l
Dengue fever attenuated tetravalent Dengue fever prophylaxis ll
Tuberculosis recombinant tuberculosis prophylaxis II
Zoster recombinant Herpes Zoster prevention ll
Flu pandemic & pre-pandemic† H5N1 inactivated split – monovalent (Quebec) pandemic influenza prophylaxis lll 2009 2009
New generation flu vaccine inactivated split – trivalent seasonal influenza prophylaxis for the elderly IIl
Simplirix recombinant genital herpes prophylaxis lll
Boostrix subunit adult booster for diphtheria, tetanus & pertussis Approved A:Jun00 A:Dec08
Pandemrix (Flu pandemic)† H5N1 inactivated split – monovalent (Dresden) pandemic influenza prophylaxis Approved A:May08
Prepandrix (Flu pre-pandemic)† H5N1 inactivated split – monovalent (Dresden) pre-pandemic influenza prophylaxis Approved A:May08
Cervarix† recombinant human papilloma virus infection prophylaxis Approved A:Sep07 AL:Dec07
Antigen Specific WT1 recombinant treatment of acute myelogenous leukaemia l
Cancer MAGE-A3 ASCI recombinant treatment of melanoma lll
Immunotherapeutic MAGE-A3 ASCI recombinant treatment of non-small cell lung cancer lll
(ASCI)

Key

† In-license or other alliance relationship with third party MAA Marketing authorisation application (Europe)

S Month of first submission NDA New drug application (USA)

A Month of first regulatory approval (for MAA, this is the first EU Phase I Evaluation of clinical pharmacology, usually conducted in volunteers
approval letter)
Phase Il Determination of dose and initial evaluation of efficacy, conducted
AL Month approvable or Complete Response letter received - in a small number of patients
indicates that ultimately approval can be given subject to
resolution of outstanding queries Phase lll Large comparative study (compound versus placebo and/or
established treatment) in patients to establish clinical benefit and safety
PO Month of EU Positive Opinion

BLA Biological License Application

Estimated submission dates are only disclosed where they are within 12 months of the date of the chart. This date represents the most likely year of submission where it is considered that there is a reasonably high probability of
successfully meeting the date assuming the clinical data meets the expected end-points of the clinical trials.

Brand names appearing in italics are trademarks either owned by and/or licensed to GlaxoSmithKline or associated companies, with the exception of Entereg, a trademark of Adolor Corporation in the US, which is used in certain
countries under licence by the Group.
Product Development Pipeline February 2009
This document outlines GlaxoSmithKline’s drug development compounds, especially those in early stages of investigation,
portfolio. The content of the drug development portfolio will may be terminated as they progress through development. For
change over time as new compounds progress from discovery competitive reasons, new projects in pre-clinical development
to development and from development to the market. Owing have not been disclosed and some project types may not have
to the nature of the drug development process, many of these been identified.

Phase I Phase Il Phase III Filed/Approved

249320 315234 belimumab† Bosatria (mepolizumab)


933776 679586 ofatumumab† ofatumumab†
iboctadekin† + Doxil belimumab† otelixizumab† Arixtra
iboctadekin† + rituximab mepolizumab Syncria† Avandia
256073 ofatumumab† Avandamet XR Volibris†
1278863 221149 Avandia + simvastatin Lunivia†
1292263 756050 darapladib† Solzira (1838262)†
1521498 184072 almorexant† Lamictal XR
1614235† losmapimod (856553) Lamictal XR Requip Modutab/XL†
2245840 pazopanib retigabine† Treximet†
932121 remogliflozin etabonate† rosiglitazone XR Duodart (Avodart + alpha
945237 rilapladib† Avodart blocker)
1265744† ronacaleret† elesclomol† pazopanib
1322322 1349572† pazopanib Zunrisa/Rezonic
163090 IDX899† pazopanib + Tyverb/Tykerb Hycamtin
424887 sitamaquine Revolade/Promacta† Revolade/Promacta†
586529† tafenoquine† Tyverb/Tykerb Tyverb/Tykerb
598809 239512 Hib-MenCY-TT (v) Entereg†
618334 468816 MenACWY-TT (v) Synflorix (v)
729327 561679† Flu pandemic & pre-pandemic† (v) Kinrix (v)
1014802 649868† New generation flu vaccine (v) Rotarix† (v)
1018921 681323 Simplirix (v) Boostrix (v)
1034702 742457 MAGE-A3 ASCI (i) Pandemrix (Flu pandemic)† (v)
1144814 firategrast† Prepandrix (Flu pre-pandemic)† (v)
1482160 Solzira (1838262)† Cervarix† (v)
orvepitant 1363089†
461364 pazopanib + Tyverb/Tykerb
923295† Revolade/Promacta†
1120212† Tyverb/Tykerb
totrombopag† 159797†
610677 159802†
656933 256066
705498 573719
962040 685698
1399686 835726
Cytomegalovirus (v) 870086
HIV (v) 642444†
NTHi-Pneumo (v) 961081†
S. pneumoniae adult (v) 1004723
WT1 (i) 2190915†
darotropium
darotropium + 642444†
Mosquirix (v)
Dengue fever (v)
Tuberculosis (v)
Zoster (v)

Key

(v) Vaccine

(i) Cancer Immunotherapeutic

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATIO N


Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements
or projections made by the company, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ
materially from those projected.
Continued development of commercially viable new products is critical to the Group’s ability to replace sales of older products that decline upon expiration of
exclusive rights, and to increase overall sales. Developing new products is a costly, lengthy and uncertain process. A new product candidate can fail at any stage
of the process, and one or more late-stage product candidates could fail to receive regulatory approval.
New product candidates may appear promising in development but, after significant investments, fail to reach the market or have only limited commercial
success as a result of efficacy or safety concerns, inability to obtain necessary regulatory approvals, difficulty or excessive costs to manufacture or infringement of
patents or other intellectual property rights of others or inability to differentiate the product adequately from those with which it competes.
Other factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's
Annual Report on Form 20-F for 2008.