GSK Annual Report 2002

16 GlaxoSmithKline Description of business
Compound Type Indication Phase MAA NDA
Neurology & Gastrointestinal
234551** endothelin A antagonist stroke I
271046 5HT6 antagonist Alzheimer’s disease & schizophrenia I
683699 (T-0047)** dual alpha4 integrin antagonist (VLA4) multiple sclerosis (MS) & inflammatory bowel I
disease (IBD) (also asthma & rheumatoid arthritis (RA))
723620** corticotropin releasing factor (CRF-R1) irritable bowel syndrome (IBS) (also anxiety I
antagonist & depression)
406381 COX-2 inhibitor (second generation) pain II
493838 adenosine A1 agonist neuropathic pain II
737004 (S-0139)* endothelin A antagonist stroke II
737552 (S-8510)* benzodiazepine inverse agonist Alzheimer’s disease & vascular dementia II
carabersat (204269) benzopyran migraine prophylaxis & epilepsy II
Imigran/Imitrex 5HT1 agonist migraine – needle-free injection II 2005 2005
talnetant (223412) tachykinin (NK3) antagonist IBS (also schizophrenia) II 2005 2005
alvimopan (ADL 8-2698)** peripheral mu-opioid antagonist post operative ileus III 2004 2003
Imigran/Imitrex 5HT1 agonist migraine – fast dissolving tablet III 2003 2003
Lamictal sodium channel inhibitor neuropathic pain III N/A 2004
Requip** non-ergot dopamine agonist Parkinson’s disease – controlled release formulation III 2005 2005
Requip non-ergot dopamine agonist restless leg syndrome III 2003 2003
Imigran/Imitrex 5HT1 agonist adolescent migraine – nasal formulation Submitted S:Sep02 AL:Dec00
Oncology, Musculoskeletal & Inflammation
251353 Groß-T CXC chemokine prevention of chemotherapy-induced cytopaenias I
462795 cathepsin K inhibitor osteoporosis & osteoarthritis I
485232** recombinant human interleukin-18 immunologically-sensitive cancers (melanoma & I
immunomodulator renal cell)
497115** thrombopoietin agonist chemoprotection I
681323 p38 alpha kinase inhibitor rheumatoid arthritis (also chronic obstructive I
pulmonary disease)
715992** kinesin inhibitor breast & ovarian cancers I
786034 vascular epidermal growth factor 2 tyrosine solid tumours I
kinase inhibitor
topotecan + 120918 topo-isomerase l inhibitor + bioenhancer cancer I
572016 ErbB-2 and EGFR dual kinase inhibitor solid tumours (breast & colorectal cancers) II 2004 2004
ethynylcytidine (596168)** selective RNA polymerase inhibitor solid tumours II
Hycamtin topo-isomerase I inhibitor small cell lung cancer first line therapy II 2004 2004
repifermin** keratinocyte Growth Factor-2 mucositis (also wound care & inflammatory II
bowel disease)
Hycamtin topo-isomerase I inhibitor non-small cell lung cancer second line therapy III 2005 N/A
Hycamtin topo-isomerase I inhibitor small cell lung cancer second line therapy III 2003 2003
– oral formulation
Hycamtin topo-isomerase I inhibitor ovarian cancer first line therapy III 2004 2004
ibandronate** bisphosphonate treatment & prevention of postmenopausal III 2004 2004
osteoporosis – monthly oral dosing
ibandronate** bisphosphonate treatment & prevention of postmenopausal III 2004 2004
osteoporosis – quarterly i.v. dosing
Navelbine** vinca alkaloid non-small cell lung cancer – oral therapy III N/A 2003
Bexxar** I131 radiolabelled anti-B1 monoclonal non-Hodgkin's lymphoma Submitted N/A S:Sep00
antibody
Hycamtin topo-isomerase I inhibitor small cell lung cancer second line therapy Submitted S:Nov02 N/A
ibandronate** bisphosphonate treatment & prevention of postmenopausal Submitted S:Jun02 S:Jul02
osteoporosis – daily oral regimen
Psychiatry
271046 5HT6 antagonist schizophrenia (& Alzheimer’s disease) I
353162 noradrenaline/dopamine re-uptake inhibitor depression & bipolar disorder I
468816 glycine antagonist smoking cessation I
679769 NK1 antagonist depression & anxiety I
723620** corticotropin releasing factor (CRF-R1) anxiety & depression (also IBS) I
antagonist
597599 NK1 antagonist depression & anxiety II
talnetant (223412) tachykinin (NK3) antagonist schizophrenia (also for IBS) II
vilazodone (659746) selective serotonin re-uptake inhibitor (SSRI) depression II 2005 2004
(EMD 68843)** + 5HT1a partial agonist
Lamictal sodium channel inhibitor bipolar disorder – acute treatment III N/A 2006
Paxil CR** SSRI premenstrual dysphoric disorder (PMDD), intermittent III N/A 2003
treatment – controlled release formulation
Lamictal sodium channel inhibitor bipolar disorder – long-term prophylaxis Submitted S:Aug02 S:Jun02
Paxil CR** SSRI PMDD continuous treatment – controlled Submitted N/A S:Jun02
release formulation
Paxil CR** SSRI social anxiety disorder Submitted N/A S:Dec02
Wellbutrin XL** noradrenaline/dopamine reuptake inhibitor depression – controlled release formulation, Submitted S:Aug02
once daily dosing