Product Development Pipeline February

2005

Product Development Pipeline February 2005

Therapeutic area Compound Type Indication Phase Estimated filing dates MAA Cardiovascular & Metabolic 659032 677116 681323 813893 480848 493838 501516 odiparcil Arixtra Coreg CR Noratak Arixtra Arixtra Arixtra Metabolic Projects 189075 856464 solabegron (427353) 677954 823093 869682 Avandamet XR Avandaryl Infectious Diseases 565154 270773 chlorproguanil, dapsone + artesunate (CDA) 275833 Etaquine sitamaquine Anti-virals 825780 640385 695634 873140 Epzicom/Kivexa 423557 423562 solabegron (427353) 462795 679769 681323 768974 856553 876008 Entereg 270384 274150 683699 Avandia Entereg talnetant Avandia Avodart + alpha blocker Avodart mepolizumab Boniva/Bonviva Boniva/Bonviva Entereg Vesicare Neurosciences 189254 234551* 274150 radafaxine (353162) 406725 644784 705498 737004* 742457 773812 823296 842166 876008 ReQuip XR radafaxine (353162) radafaxine (353162) 372475 406381 468816 vestipitant (597599) + paroxetine 679769 683699 Avandia talnetant Lamictal Lamictal XR Lamictal XR ReQuip CR Trexima Wellbutrin XL ReQuip Wellbutrin XL Oncology 743921 elacridar 497115 485232 vestipitant (597599) 679769 715992 786034 ethynylcytidine lapatinib Hycamtin Hycamtin nelarabine Hycamtin Respiratory 159802 642444 656933 681323 856553 159797 202405 274150 597901 678007 685698 766994 799943 842470 mepolizumab Avamys/Allermist (685698) Seretide/Advair Seretide Serevent Ariflo Seretide/Advair Hepatitis Vaccines Hepatitis E Fendrix Extra Strength hepatitis B Rotarix Streptorix N. meningitidis combinations Priorix-Tetra (MMR-varicella) HIV Flu improved S. pneumoniae elderly Varicella Zoster Dengue fever Epstein-Barr virus Mosquirix Staphylococcal antibodies Cervarix Simplirix Boostrix Breast cancer therapeutic (Her 2 Neu) P501 mage 3 (249553) Lp-PLA2 inhibitor Lp-PLA2 inhibitor p38 kinase inhibitor factor Xa inhibitor Lp-PLA2 inhibitor adenosine A1A agonist PPAR delta agonist indirect thrombin inhibitor synthetic factor Xa inhibitor beta blocker recombinant B-type natriuretic peptide synthetic factor Xa inhibitor synthetic factor Xa inhibitor synthetic factor Xa inhibitor sodium dependent glucose transport (SGLT2) inhibitor melanin concentrating hormone antagonist beta3 adrenergic agonist PPAR pan agonist DPP IV inhibitor SGLT2 inhibitor PPAR gamma agonist plus metformin PPAR gamma agonist plus sulphonylurea oral pleuromutilin phospholipid anti-endotoxin emulsion antifolate + artemisinin topical pleuromutilin 8-aminoquinoline 8-aminoquinoline DNA antiviral vaccine aspartyl protease inhibitor non-nucleoside reverse transcriptase inhibitor CCR5 antagonist reverse transcriptase inhibitor calcium antagonist calcium antagonist beta3 adrenergic agonist cathepsin K inhibitor NK1 antagonist p38 kinase inhibitor parathyroid hormone agonist p38 kinase inhibitor (oral) corticotrophin releasing factor (CRF1) antagonist peripheral mu-opioid antagonist endothelial cell adhesion molecule inhibitor selective iNOS inhibitor dual alpha4 integrin antagonist (VLA4) PPAR gamma agonist peripheral mu-opioid antagonist NK3 antagonist PPAR gamma agonist 5-alpha reductase inhibitor plus alpha blocker 5-alpha reductase inhibitor anti-IL5 monoclonal antibody bisphosphonate bisphosphonate peripheral mu-opioid antagonist muscarinic antagonist histamine H3 antagonist endothelin A antagonist selective iNOS inhibitor noradrenaline/dopamine re-uptake inhibitor gap junction blocker dual acting COX-2 inhibitor vanilloid 1 antagonist endothelin A antagonist 5HT6 antagonist mixed 5HT/dopaminergic antagonist NK1 antagonist non-cannabinoid CB2 agonist CRF1 antagonist non-ergot dopamine agonist noradrenaline/dopamine re-uptake inhibitor noradrenaline/dopamine re-uptake inhibitor triple (5HT/noradrenaline/dopamine) reuptake inhibitor dual acting COX-2 inhibitor glycine antagonist NK1 antagonist + selective serotonin re-uptake inhibitor NK1 antagonist dual alpha4 integrin antagonist (VLA4) PPAR gamma agonist NK3 antagonist sodium channel inhibitor sodium channel inhibitor sodium channel inhibitor non-ergot dopamine agonist 5HT1 agonist + naproxen noradrenaline/dopamine re-uptake inhibitor non-ergot dopamine agonist noradrenaline/dopamine re-uptake inhibitor kinesin spindle protein (KSP) inhibitor oral bioenhancer thrombopoietin agonist recombinant human IL18 immunomodulator NK1 antagonist NK1 antagonist KSP inhibitor vascular endothelial growth factor 2 tyrosine kinase inhibitor selective RNA polymerase inhibitor ErbB-2 and EGFR dual kinase inhibitor topo-isomerase I inhibitor topo-isomerase I inhibitor guanine arabinoside prodrug topo-isomerase I inhibitor long acting beta2 agonist long acting beta2 agonist IL8 antagonist p38 kinase inhibitor (oral) p38 kinase inhibitor (oral) long acting beta2 agonist muscarinic antagonist selective iNOS inhibitor (oral) long acting beta2 agonist long acting beta2 agonist glucocorticoid agonist chemokine 3 (CCR3) antagonist (oral) glucocorticoid agonist PDE IV inhibitor (inhaled) anti-IL5 monoclonal antibody glucocorticoid agonist beta2 agonist/inhaled corticosteroid beta2 agonist/inhaled corticosteroid beta2 agonist PDE IV inhibitor (oral) beta2 agonist/inhaled corticosteroid recombinant recombinant live attenuated oral conjugated conjugated live attenuated recombinant subunit recombinant recombinant attenuated tetravalent vaccine recombinant recombinant monoclonal antibody recombinant recombinant subunit recombinant recombinant recombinant atherosclerosis atherosclerosis atherosclerosis (also rheumatoid arthritis & COPD) prevention of stroke in atrial fibrillation atherosclerosis dyslipidaemia dyslipidaemia prevention of thrombotic complications of cardiovascular disease & DVT prophylaxis treatment of acute coronary syndrome hypertension & congestive heart failure once daily acute heart failure prevention of deep vein thrombosis abdominal surgery prevention of deep vein thrombosis medical conditions treatment of deep vein thrombosis type 2 diabetes obesity type 2 diabetes (also overactive bladder) type 2 diabetes type 2 diabetes type 2 diabetes type 2 diabetes extended release type 2 diabetes fixed dose combination treatment of respiratory tract infections sepsis treatment of uncomplicated malaria bacterial skin infections malaria prophylaxis (adults) treatment of visceral leishmaniasis HIV infections HIV infections HIV infections HIV infections HIV infections combination tablet osteoporosis osteoporosis overactive bladder (OAB) (also type 2 diabetes) osteoporosis & osteoarthritis urge incontinence (also depression & anxiety, chemotherapy induced & postoperative nausea & vomiting) rheumatoid arthritis (also atherosclerosis & COPD) osteoporosis rheumatoid arthritis (also COPD) irritable bowel syndrome (IBS) (also depression & anxiety) IBS inflammatory bowel disease rheumatoid arthritis (also migraine & asthma) inflammatory bowel disease (also multiple sclerosis) rheumatoid arthritis chronic opiate induced bowel dysfunction & constipation IBS (also schizophrenia) psoriasis benign prostatic hyperplasia fixed dose combination reduction in the risk of prostate cancer hypereosinophillic syndrome & eosinophilic esophagitis (also asthma) treatment of postmenopausal osteoporosis intermittent i.v. dosing treatment & prevention of postmenopausal osteoporosis monthly oral dosing post operative ileus overactive bladder dementia stroke migraine (also rheumatoid arthritis & asthma) fibromyalgia & neuropathic pain migraine, epilepsy & neuropathic pain acute & chronic pain conditions including neuropathic pain (also schizophrenia) acute migraine stroke schizophrenia & dementia schizophrenia depression & anxiety inflammatory pain depression & anxiety (also IBS) restless leg syndrome (RLS) depression RLS depression acute and chronic pain & migraine smoking cessation depression & anxiety depression & anxiety (also chemotherapy induced & postoperative nausea & vomiting and urge incontinence) multiple sclerosis (also inflammatory bowel disease) Alzheimer's disease schizophrenia (also IBS) bipolar disorder acute treatment neuropathic pain (& epilepsy, NDA only) once daily schizophrenia Parkinsons disease once daily controlled release formulation migraine fixed dose combination seasonal affective disorder RLS depression cancer cancer thrombocytopaenia immunologically-sensitive cancers (melanoma & renal cell) postoperative nausea & vomiting (also chemotherapy induced nausea & vomiting) chemotherapy induced & postoperative nausea & vomiting (also depression & anxiety and urge incontinence) non small cell lung cancer & other tumours solid tumours solid tumours breast cancer (also renal, lung, bladder, gastric, head & neck cancers) ovarian cancer first line therapy small cell lung cancer second line therapy oral formulation acute lymphoblastic leukaemia & lymphomas small cell lung cancer second line therapy asthma & chronic obstructive pulmonary disease (COPD) asthma & COPD COPD COPD (also rheumatoid arthritis & atherosclerosis) COPD (also rheumatoid arthritis) COPD, also COPD & asthma in combination with a glucocorticoid agonist COPD asthma (also migraine & rheumatoid arthritis) COPD, also COPD & asthma in combination with a glucocorticoid agonist COPD, also COPD & asthma in combination with a glucocorticoid agonist asthma & COPD in combination with a long acting beta2 agonist (also allergic rhinitis) asthma & allergic rhinitis asthma & COPD in combination with a long acting beta2 agonist COPD asthma (also hypereosinophillic syndrome & eosinophilic esophagitis) allergic rhinitis COPD mortality claim asthma initial maintenance therapy asthma & COPD non-CFC inhaler COPD asthma non-CFC inhaler hepatitis E prophylaxis extra strength hepatitis B prophylaxis (pre-hemodialysis and hemodialysis patients) rotavirus prophylaxis S. pneumoniae disease prophylaxis for children meningitis prophylaxis measles, mumps, rubella and varicella prophylaxis HIV prophylaxis influenza prophylaxis S. pneumoniae disease prophylaxis Varicella Zoster prevention prophylactic use EBV prophylaxis malaria prophylaxis prevention of staphylococcal infections prophylaxis of human papillovirus infections genital herpes prophylaxis adolescent/adult booster for diphtheria, tetanus and pertussis treatment of breast cancer treatment of prostate cancer treatment of lung cancer/melanoma l I I I II II II II III III III Submitted Approved Approved I I II II II II III Approvable I II II III III III I II II II Approved I I I I I I I I I I II II II II II II III III III III Submitted Submitted Submitted Approved I I I I I I I I I I l I I I II II II II II II II II II II III III III III III Submitted Approved Approved I I Il II II II II II II III III III lll Approved I I I I I II II II II II II II II II II III III Submitted Submitted Approvable Approved II Approved lll III Submitted Submitted I I I I II II II II III III Approved I I II 2006 2006 S:Aug04 S:Apr04 A:Jun00 2006 2006 N/A N/A AL:Oct03 AL:Oct01 & Oct02 2006 N/A 2007 S:Jul04 A:Jan05 A:Nov04 2006 2005 N/A S:Jul04 S:Feb04 A:Jun04 NDA

2005

2005 AL:Aug04

2007 2006 TBD

N/A 2005 2007 N/A

2007 2007 A:Dec04

2007 2007 A: Aug04

Musculoskeletal, Inflammation, Gastrointestinal Urology

2007

2007

2007 2007 2007 2006 2005 S:Sep04 2005 N/A

2007 2007 2007 2006 S:Dec04 S:May04 S:Jun04 A:Nov04

2007

2007

2006

2006 2007

TBD

TBD

N/A 2006 2005 N/A A:Jun04 2006

2006 2006 2007 2005 2005 S:Dec04 AL:Dec03 A:Aug03

2006 2007 2006

2006 2007 2006

2006 2006 2006 2005 2005

2005 2006 2006 2005 A:Nov98

A:Feb05 2005 2007 S:Feb05 S:Apr04

Paediatric Vaccines

2007

Other Vaccines

2006 A:Oct00 S:Jun04

Pharmacccines

KEY (v) (p) * S A AL Vaccine Pharmaccine Compounds in Shionogi-GlaxoSmithKline Pharmaceuticals LLC joint venture In-license or other alliance relationship with third party Date of first submission Date of first Regulatory approval (for MAA, this is the first EU approval letter) Approvable letter Phase I Phase II Evaluation of clinical pharmacology, usually conducted in volunteers Determination of dose and initial evaluation of efficacy, conducted in a small number of patients

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forwardlooking 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 Groups 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 2004.

Phase III Large comparative study (compound versus placebo and/or established treatment) in patients to establish clinical benefit and safety

All product names in italics are trademarks of the GlaxoSmithKline Group of companies except Coreg, a trademark under licence from Roche Laboratories Inc, Bonviva/Bonviva, a trademark of F. Hoffmann - La Roche Ltd, Entereg, a trademark of Adolor Corporation and Vesicare, a trademark of Yamanouchi Pharmaceutical Co. Ltd. For competitive reasons, new projects in pre-clinical development have not been disclosed and some project types may not have been identified.

Product Development Pipeline February 2005

This document outlines GlaxoSmithKlines drug development portfolio. The content of the portfolio will change over time as new compounds progress from research to development and from development to the market. Owing to the nature of the drug development process, it is not unusual for some compounds, especially those in early stages of investigation, to be terminated as they progress through development.

Phase I 659032 677116 681323 813893 189075 856464 565154 825780 423557 423562 427353 462795 679769 768974 856553 876008 Entereg 189254 234551* 274150 353162 406725 644784 705498 737004* 742457 773812 823296 842166 ReQuip XR 743921 elacridar 159802 642444 656933 HIV (v) Flu improved (v) S. pneumoniae elderly (v) Varicella Zoster (v) Breast cancer therapeutic (Her 2 Neu) (p) P501-prostate (p)

Phase II 480848 493838 501516 odiparcil 427353 677954 823093 869682 270773 chlorproguanil, dapsone + artesunate (CDA) 640385 695634 873140 270384 274150 683699 Avandia Entereg talnetant radafaxine (353162) 372475 (NS2359) 406381 468816 vestipitant (597599) + paroxetine 679769 485232 497115 vestipant (597599) 715992 786034 ethynylcytidine 159797 202405 597901 678007 685698 766994 799943 842470 mepolizumab Hepatitis E (v) Dengue fever (v) Epstein-Barr virus (v) Mosquirix (v) Staphylococcal antibodies (v) mage 3 (249553) (p)

Phase III Noratak Coreg CR Arixta Avandamet XR 275833 Etaquine sitamaquine Avandia Avodart + alpha blocker Avodart mepolizumab Lamictal Lamictal XR ReQuip CR Trexima lapatinib Hycamtin nelarabine Allermist/Avamys (685698) Seretide/Advair Rotarix (v) Streptorix (v) Simplirix (v) Cervarix (v)

Filed/Approved Avandaryl Arixtra Epzicom/Kivexa Boniva/Bonviva Entereg Vesicare ReQuip Wellbutrin XL Hycamtin Seretide/Advair Serevent Ariflo N. meningtidis combination (v) Fendrix Extra Strength hepatitis B (v) Priorix-Tetra (MMR-varicella) (v) Boostrix (v)