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Product Development Pipeline
2007
September
 
Product Development PipelineSeptember 2007
Cardiovascular Cardiovascular projects& Metabolic
256073 high affinity nicotinic acid receptor dyslipidaemia I(HM74A) agonist813893 factor Xa inhibitor prevention of stroke in atrial fibrillation IrilapladibLp-PLA2 inhibitor atherosclerosis I681323 p38 kinase inhibitor atherosclerosis (also chronic obstructive pulmonary disease llCOPD, neuropathic pain & rheumatoid arthritis)856553 p38 kinase inhibitoratherosclerosis (also rheumatoid arthritis & COPD)lldarapladibLp-PLA2 inhibitor atherosclerosis ll/III
Coreg CR
+ACE inhibitor beta blocker + angiotensin converting hypertension fixed dose combination III N/Aenzyme inhibitor
Volibris
(ambrisentan)endothelin A antagonist pulmonary arterial hypertension Submitted S:Mar07 N/A
 Arixtra
synthetic factor Xa inhibitor treatment of acute coronary syndrome Approved A:Aug07 AL:Feb07&Sep07
Metabolic projects
189075sodium dependent glucose transport (SGLT2) obesity Iinhibitor376501 PPAR gamma partial agonist type 2 diabetes I189075SGLT2 inhibitor type 2 diabetes ll
Syncria
(albiglutide)glucagon-like peptide 1 agonist type 2 diabetes II
 Avandamet XR
PPAR gamma agonist + metformin type 2 diabetes extended release III N/A 2008*
 Avandia
PPAR gamma agonist atherosclerosis in type 2 diabetes IIl
 Avandia
PPAR gamma agonist prevention of diabetes III N/A 2008*
 Avandia
+simvastatin PPAR gamma agonist + statin type 2 diabetes III N/A 2008*
 Avandia
PPAR gamma agonist prevention of disease progression Submitted 2008* S:Feb07
Infectious Diseases
580416ribosome inhibitortreatment of bacterial infectionsl945237topoisomerase ll inhibitortreatment of bacterial infectionslfarglitazar PPAR gamma agonist hepatic fibrosis IIsitamaquine 8-aminoquinolinetreatment of visceral leishmaniasis II N/Atafenoquine8-aminoquinoline
Plasmodium vivax 
malaria II
Dacart 
(chlorproguanil, antifolate + artemisinin treatment of uncomplicated malaria IIl 2008 N/Adapsone + artesunate)
 Altabax/Altargo
topical pleuromutilin bacterial skin infections Approved A:May07 A:Apr07
Musculoskeletal,
1827771interleukin 1 antagonistrheumatoid arthritisl
Inflammation,
221149 oxytocin antagonist threatened pre-term labour I
Gastrointestinal
315234 monoclonal antibody rheumatoid arthritis I
& Urology
768974parathyroid hormone agonist osteoporosis I971086androgen modulatorsarcopaenialpazopanibvascular endothelial growth factor (VEGF) age-related macular degeneration (also cancer indications)ltyrosine kinase inhibitor232802 3G-selective oestrogen receptor modulator treatment of menopausal symptoms ll274150 selective iNOS inhibitor rheumatoid arthritis (also migraine) II681323 p38 kinase inhibitor (oral) rheumatoid arthritis (also atherosclerosis, COPD II&neuropathic pain)856553 p38 kinase inhibitor (oral) rheumatoid arthritis (also atherosclerosis & COPD) II876008corticotrophin releasing factor (CRF1) antagonist irritable bowel syndrome (also depression & anxiety) IIofatumumabhuman monoclonal antibodyrheumatoid arthritis (also cancer indications)llronacaleret (751689)calcium antagonistosteoporosis & fracture healingllsolabegron beta3 adrenergic agonist irritable bowel syndrome IIsolabegron beta3 adrenergic agonist overactive bladder II
 Avodart 
5-alpha reductase inhibitor reduction in the risk of prostate cancer III
 Avodart 
+alpha blocker 5-alpha reductase inhibitor + alpha blocker benign prostatic hyperplasia fixed dose combination IIIbelimumabanti-B lymphocyte stimulator monoclonal systemic lupus erythematosus IIIantibody
Bosatria
(mepolizumab) anti-IL5 monoclonal antibody hypereosinophilic syndrome (also severe asthma & nasalIII20082008polyposis)
Entereg/Entrareg
peripheral mu-opioid antagonist opioid-induced bowel dysfunction III
Entereg/Entrareg
peripheral mu-opioid antagonist post operative ileus Approvable AL:Jul05&Nov06
Neurosciences
163090 5HT1 antagonist depression & anxiety I239512 histamine H3 antagonist dementia I249320monoclonal antibodyneuronal injuryl561679CRF1 antagonist depression & anxiety I588045 5HT1 antagonist depression & anxiety I598809 dopamine D3 antagonist drug dependency I618334dopamine D3 antagonistdrug dependencyl729327 AMPA receptor modulator schizophrenia I933776monoclonal antibodyAlzheimers diseasel1014802sodium channel inhibitorbipolar disorderl1018921type 1 glycine transport inhibitorschizophrenialorvepitant (823296) NK1 antagonist depression & anxiety I189254histamine H3 antagonistnarcolepsyll274150 selective iNOS inhibitor migraine (also rheumatoid arthritis) II372475triple (5HT/noradrenaline/dopamine) re-uptake depression IIinhibitor468816 glycine antagonist smoking cessation II649868orexin antagonist sleep disorders II681323 p38 kinase inhibitor neuropathic pain (also atherosclerosis, COPD & rheumatoidIIarthritis)742457 5HT6 antagonist dementia II773812 mixed 5HT/dopaminergic antagonist schizophrenia II842166 non-cannabinoid CB2 agonist inflammatory pain II876008CRF1 antagonist depression & anxiety (also irritable bowel syndrome) IIcasopitant NK1 antagonist depression & anxiety (also as
Rezonic/Zunrisa
for IIchemotherapy-induced & postoperative nausea & vomiting)1838262 (XP13512)voltage-gated calcium channel modulatorneuropathic painllfirategrast (683699)dual alpha4 integrin antagonist (VLA4) multiple sclerosis II1838262 (XP13512)voltage-gated calcium channel modulatorrestless legs syndromelllN/A2008
Lamictal XR
sodium channel inhibitor epilepsy partial generalised tonic-clonic seizures, once-dailyIIIN/A2008rosiglitazone XRPPAR gamma agonist Alzheimer's disease IIIgepirone ER5HT1a agonist major depressive disorder, once-daily Submitted S:May07
Lamictal XR
sodium channel inhibitor epilepsy partial seizures, once-daily Approvable N/A AL:Sep07
ReQuip
extended release non-ergot dopamine agonist restless legs syndrome Approvable N/A AL:Aug07
Trexima
5HT1 agonist + naproxen migraine fixed dose combination Approvable N/A AL:Jun06&Aug07
ReQuip Modutab/XL
24 hournon-ergot dopamine agonist Parkinson’s disease once-daily controlled release Approved A:Mar07 S:Feb07formulation
Oncology
690693AKT kinase inhibitorcancerl923295centromere-associated protein E (CENP-E)cancerlinhibitorpazopanib VEGF tyrosine kinase inhibitormetastatic colorectal cancer (in combination with other Itreatment regimens)iboctadekin+rituximablL18 immunomodulator + anti-CD20 non-Hodgkins lymphomalmonoclonal antibodytotrombopag (559448)thrombopoietin agonist thrombocytopaenia IpazopanibVEGF tyrosine kinase inhibitornon-small cell lung cancer,adjuvant therapyllpazopanibVEGF tyrosine kinase inhibitorovarian cancer,first-line therapyllpazopanibVEGF tyrosine kinase inhibitorsarcomallpazopanib +
Tykerb
VEGF tyrosine kinase inhibitor + ErbB-2 and metastatic breast cancer IIepidermal growth factor receptor (EGFR)dual kinase inhibitorpazopanib +
Tykerb
VEGF tyrosine kinase inhibitor + ErbB-2 and other cancers IIEGFR dual kinase inhibitor
Promacta/Revolade
thrombopoietin agonist chemotherapy-induced thrombocytopaenia II
Promacta/Revolade
thrombopoietin agonist hepatitis C II
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitorhead & neck squamous cell carcinomas (unresectable disease)ll
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitorrefractory inflammatory breast cancerll
Hycamtin
topoisomerase I inhibitor ovarian cancer, first-line therapy IIIofatumumabhuman monoclonal antibody refractory chronic lymphocytic leukaemia (also rheumatoid IIIarthritis)ofatumumabhuman monoclonal antibodyrefractory follicular lymphoma (also rheumatoid arthritis)lllpazopanib VEGF tyrosine kinase inhibitor renal cell cancer III
Promacta/Revolade
thrombopoietin agonist long-term idiopathic thrombocytopaenic purpura III2008
Promacta/Revolade
thrombopoietin agonist short-term idiopathic thrombocytopaenic purpura III20082007/08
Rezonic/Zunrisa
(casopitant)NK1 antagonistchemotherapy-induced & postoperative nausea & vomitingIII20082008(also depression & anxiety)
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitor breast cancer, adjuvant therapy III
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitorbreast cancer brain metastaseslll
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitor breast cancer, first-line therapy III
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitor head & neck squamous cell carcinomas (resectable disease) III
Hycamtin
topoisomerase I inhibitor small cell lung cancer, second-line therapy oral formulation SubmittedS:May07S:Apr07
 Arranon/Atriance
guanine arabinoside prodrug acute lymphoblastic leukaemia & lymphomas Approved A:Aug07 A:Oct05
Tykerb/Tyverb
ErbB-2 and EGFR dual kinase inhibitor refractory breast cancer Approved S:Oct06 A:Mar07
Respiratory
256066 PDE IV inhibitor (inhaled) COPD I656933interleukin 8 antagonistcystic fibrosisl961081muscarinic antagonist, beta2 agonist COPD I159797long-acting beta2 agonist COPD, also COPD & asthma in combination with a IIglucocorticoid agonist159802long-acting beta2 agonist COPD, also COPD & asthma in combination with a IIglucocorticoid agonist233705 muscarinic acetylcholine antagonist COPD II256066 PDE IV inhibitor (inhaled) asthma II256066 PDE IV inhibitor (intranasal) allergic rhinitis II573719 muscarinic acetylcholine antagonist COPD Il642444long-acting beta2 agonist COPD, also COPD & asthma in combination with a IIglucocorticoid agonist679586 monoclonal antibody severe asthma Il681323 p38 kinase inhibitor (oral) COPD (also atherosclerosis, neuropathic pain & IIrheumatoid arthritis)685698 glucocorticoid agonist asthma, also COPD & asthma in combination with a IIlong-acting beta2 agonist (also as
 Avamys/Veramyst 
forallergic rhinitis)784568 glucocorticoid agonist (intranasal) allergic rhinitis II856553 p38 kinase inhibitor (oral) COPD (also atherosclerosis & rheumatoid arthritis) II870086 novel glucocorticoid agonist asthma IImepolizumab anti-IL5 monoclonal antibody severe asthma & nasal polyposis (also hypereosinophilic IIsyndrome)
Seretide/Advair 
beta2 agonist/inhaled corticosteroid COPD mortality claim / extended useSubmitted/ S:Sep06/ S:Oct06ApprovedA:Jul07
 Avamys/Veramyst 
glucocorticoid agonist allergic rhinitis Approved S:Jul06 A:Apr07
Paediatric Vaccines
Hib-MenCY-TT conjugated
Neisseria meningitis
groups C & Y disease & III
Haemophilus influenzae
type b disease prophylaxisMenACWY-TT conjugated
Neisseria meningitis
groups A, C, W & Y disease prophylaxisIIl
Synflorix 
conjugated
Streptococcus pneumoniae &
non-typeable
Haemophilus
lll 2007
influenzae
disease prophylaxis for children
Globorix 
conjugated diptheria, tetanus, pertussis, hepatitis B,
Haemophilus
Submitted S:Mar07
influenzae
type b disease,
Neisseria meningitis
groupsA&Cdisease prophylaxis
Infanrix-IPV/Kinrix 
subunit-inactivated diptheria, tetanus, pertussis + poliomyelitis prophylaxisSubmittedS:Apr07(booster-5th dose)
Rotarix 
live attenuated (oral) rotavirus-induced gastroenteritis prophylaxis Approved A:Feb06 S:Jun07
Other Vaccines
Cytomegalovirusrecombinantcytomegalovirus infection prophylaxislHIVrecombinantHIV infection prophylaxis l
S. pneumoniae
adultrecombinant-conjugated
Streptococcus pneumoniae
disease prophylaxis lDengue fever attenuated tetravalent Dengue fever prophylaxis llEpstein-Barr virusrecombinant EBV infection prophylaxis llHepatitis E virusrecombinant hepatitis E prophylaxis ll
Mosquirix 
recombinant malaria prophylaxis llTuberculosisrecombinant tuberculosis prophylaxis IIVaricella Zoster virus recombinant Varicella Zoster prevention IINew generation flu vaccine inactivated split trivalent seasonal influenza prophylaxis for the elderly III
Simplirix 
recombinant genital herpes prophylaxis lllFlu pandemicH5N1 inactivated split monovalentpandemic influenza prophylaxisSubmittedS:Feb07Flu pre-pandemic H5N1 inactivated split monovalent pandemic influenza prophylaxis Submitted S:Jan07
Cervarix 
recombinant human papilloma virus infection prophylaxis Approved A:Sep07 S:Mar07
Daronrix 
inactivated whole - monovalent pandemic influenza prophylaxis ApprovedA:Mar07
Pharmaccines
MAGE-A3recombinanttreatment of melanomallMAGE-A3recombinant treatment of non-small cell lung cancer lll
Ther
 
apeuti
 
c ar
 
e
 
aCompoundT
 
ypeIndi
 
cati
 
onPhaseE
 
stimatedsubmi
 
s
 
si
 
on date
 
sMAANDA
 
/BL
 
A
 
Brand names appearing in italics are trademarks either owned by and/or licensed to GlaxoSmithKline or associated companies, with theexception of
Entereg
, a trademark of Adolor Corporation in the USA, which is used in certain countries under licence by the Group.
Key
(v)VaccineMAAMarketing authorisation application (Europe) (p)PharmaccineNDANew drug application (USA) In-license or other alliance relationship with third partyPhase IEvaluation of clinical pharmacology, usually conducted in volunteers*Subject to completion of ongoing regulatory discussions.Phase IIDetermination of dose and initial evaluation of efficacy,SDate of first submissionconducted in a small number of patientsADate of first regulatory approval (for MAA, this is the first EUPhase IIILarge comparative study (compound versus placebo approval letter)and/or established treatment) in patients to establishclinical benefit and safety.ALApprovable letter indicates that ultimately approval can begiven subject to resolution of outstanding queries
CAUT
 
IO
 
NA
 
RY S
 
TATEME
 
NT REG
 
A
 
RD
 
IN
 
G F
 
ORWA
 
RD-LO
 
OK
 
ING INF
 
O
 
RMAT
 
ION
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of1995, the company cautions investors that any forward-looking statements orprojections made by the company, including those made in this document, are subjectto risks and uncertainties that may cause actual results to differ materially from thoseprojected.Continued development of commercially viable new products is critical to the Group’sability to replace sales of older products that decline upon expiration of exclusiverights, and to increase overall sales. Developing new products is a costly, lengthy anduncertain process. A new product candidate can fail at any stage of the process, andone or more late-stage product candidates could fail to receive regulatory approval.New product candidates may appear promising in development but, after significantinvestments, fail to reach the market or have only limited commercial success as a resultof efficacy or safety concerns, inability to obtain necessary regulatory approvals,difficulty or excessive costs to manufacture or infringement of patents or otherintellectual property rights of others or inability to differentiate the productadequately 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 Reporton Form 20-F for 2006.
 
Estimated submission dates are only disclosed where they are within 12 months of the date of the chart. This date represents the most likelyyear of submission where it is considered that there is a reasonably high probability of successfully meeting the date assuming the clinicaldata meets the expected end-points of the clinical trials.
 
This document outlines GlaxoSmithKline’s drug developmentportfolio. The content of the drug development portfolio willchange over time as new compounds progress from discoveryto development and from development to the market. Owingto the nature of the drug development process, many of thesecompounds, especially those in early stages of investigation,may be terminated as they progress through development. Forcompetitive reasons, new projects in pre-clinical developmenthave not been disclosed and some project types may not havebeen identified.
Product Development PipelineSeptember 2007
Phase IPhase IIPhase IIIFiled/Approved681323856553darapladib189075
Syncria
(albiglutide)farglitazarsitamaquinetafenoquine232802274150876008ronacaleret (751689)ofatumumabsolabegron189254372475468816649868742457773812842166casopitant1838262 (XP13512)firategrast (683699)pazopanibpazopanib +
TykerbPromacta/Revolade
Tykerb/Tyverb
159797159802233705256066573719642444679586685698784568870086mepolizumabDengue fever (v)Epstein-Barr virus (v)Hepatitis E (v)
Mosquirix 
(v)Tuberculosis (v)Varicella Zoster (v)MAGE-A3 (p)
Coreg CR
+ACE Inhibitor
 Avandamet XR Avandia Avandia +
simvastatin
Dacart 
(chlorproguanil, dapsone+artesunate)
 Avodart  Avodart 
+alpha blockerbelimumab
Bosatria
(mepolizumab)
Entereg/Entrareg
1838262 (XP13512)
Lamictal XR
rosiglitazone XR
Hycamtin
ofatumumabpazopanib
Promacta/Revolade
Rezonic/Zunrisa
(casopitant)
Tykerb/Tyverb
MenACWY-TT (v)Hib-MenCY-TT(v)
Synflorix (v)
New generation flu vaccine (v)
Simplirix 
(v)MAGE-A3 (p)
Volibris
(ambrisentan)
 Avandia Arixtra Altabax/AltargoEntereg/Entrareg
gepirone ER
Lamictal XRReQuip extended releaseTrexima
ReQuip Modutab
 /XL 24 hour
Hycamtin Arranon/AtrianceTykerb/TyverbSeretide/Advair  Avamys/Allermist Globorix 
(v)
Infranrix-IPV/Kinrix (v)Rotarix 
(v)Flu pandemic (v)Flu pre-pandemic (v)
Cervarix 
(v)Daronrix (v)256073813893rilapladib1890753765015804169452371827771221149315234768974971086pazopanib163090239512249320561679588045598809618334729327933176orvepitant (823296)10148021018921690693923295iboctadekin+rituximabtotrombopag (559448)256066656933961081cytomegalovirus (v)HIV (v)
S. pneumoniae
adult (v)

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