GlaxoSmithKline Drug R&D Pipeline - Feburary 2009

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Product Development Pipeline 2009 February

Transcript of GlaxoSmithKline Drug R&D Pipeline - Feburary 2009

Page 1: GlaxoSmithKline Drug R&D Pipeline - Feburary 2009

Product Development Pipeline

2009February

Page 2: GlaxoSmithKline Drug R&D Pipeline - Feburary 2009

Product Development Pipeline February 2009

Biopharmaceuticals 249320 monoclonal antibody stroke I933776 monoclonal antibody Alzheimer’s disease Iiboctadekin† + Doxil IL18 immunomodulator + topoisomerase ll ovarian cancer l

inhibitoriboctadekin† + rituximab IL18 immunomodulator + anti-CD20 non-Hodgkin’s lymphoma l

monoclonal antibody315234 monoclonal antibody rheumatoid arthritis ll679586 monoclonal antibody severe asthma llbelimumab† anti-B lymphocyte stimulator monoclonal systemic lupus erythematosus Il

antibody (s.c.)mepolizumab anti-IL5 monoclonal antibody severe asthma & nasal polyposis llofatumumab† anti-CD20 human monoclonal antibody diffuse large B cell lymphoma IIofatumumab† anti-CD20 human monoclonal antibody multiple sclerosis IIbelimumab† anti-B lymphocyte stimulator monoclonal systemic lupus erythematosus III

antibody (i.v.)ofatumumab† anti-CD20 human monoclonal antibody follicular lymphoma lllofatumumab† anti-CD20 human monoclonal antibody rheumatoid arthritis lllotelixizumab† anti-CD3 monoclonal antibody type 1 diabetes lllSyncria† glucagon-like peptide 1 agonist type 2 diabetes lllBosatria (mepolizumab) anti-IL5 monoclonal antibody hypereosinophilic syndrome Submitted S:Sep08ofatumumab† 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 I1292263 gastrin-releasing peptide (GRP) receptor agonist type 2 diabetes l1521498 mu-opioid receptor inverse agonist obesity l1614235† sodium dependent glucose transport (SGLT1) type 2 diabetes l

inhibitor2245840 SIRT1 activator type 2 diabetes (also chronic obstructive pulmonary disease, l

COPD)221149 oxytocin antagonist threatened pre-term labour ll756050 bile acid receptor agonist type 2 diabetes ll184072 SIRT1 activator type 2 diabetes (also oncology indications) llIosmapimod (856553) p38 kinase inhibitor cardiovascular disease (also COPD & depression) llpazopanib multi-kinase angiogenesis inhibitor (eye drops) age-related macular degeneration (also cancer indications) llremogliflozin etabonate† SGLT2 inhibitor type 1 diabetes llremogliflozin etabonate† SGLT2 inhibitor type 2 diabetes llrilapladib† Lp-PLA2 inhibitor atherosclerosis llronacaleret† calcium antagonist osteoporosis & fracture healing llAvandamet XR PPAR gamma agonist + metformin type 2 diabetes – extended release lll N/AAvandia + simvastatin PPAR gamma agonist + statin type 2 diabetes lll N/Adarapladib† Lp-PLA2 inhibitor atherosclerosis IIIArixtra synthetic factor Xa inhibitor treatment of acute coronary syndrome Approved A:Aug07 AL:Feb07

& Sep07Avandia PPAR gamma agonist prevention of disease progression Approved S:Nov08 A:Jul08Volibris† endothelin A antagonist pulmonary arterial hypertension Approved A:Apr08 N/A

Infectious Diseases 932121 plasmodium electron transport chain inhibitor malaria l945237 topoisomerase ll inhibitor treatment of bacterial infections l1265744† HIV integrase inhibitor HIV infections l1322322 novel class antibacterial agent treatment of bacterial infections l1349572† HIV integrase inhibitor HIV infections llIDX899† non-nucleotide reverse transcriptase inhibitor HIV infections llsitamaquine 8-aminoquinoline treatment of visceral leishmaniasis II N/Atafenoquine† 8-aminoquinoline Plasmodium vivax malaria II

Neurosciences 163090 5HT1 antagonist depression & anxiety I424887 NK1 antagonist/SSRI depression & anxiety l586529† CRF1 antagonist depression & anxiety l598809 dopamine D3 antagonist drug dependency I618334 dopamine D3 antagonist drug dependency l729327 AMPA receptor modulator schizophrenia I1014802 sodium channel blocker bipolar disorder l1018921 type 1 glycine transport inhibitor schizophrenia l1034702 muscarinic acetylcholine agonist dementia l1144814 NK1/NK3 antagonist schizophrenia l1482160 purinergic ATP receptor antagonist pain lorvepitant NK1 antagonist depression & anxiety l239512 histamine H3 antagonist dementia ll468816 glycine antagonist smoking cessation II561679† CRF1 antagonist depression & anxiety Il649868† orexin antagonist sleep disorders II681323 p38 kinase inhibitor neuropathic pain II742457 5HT6 antagonist dementia llfirategrast† dual alpha4 integrin antagonist (VLA4) multiple sclerosis IIlosmapimod (856553) p38 kinase inhibitor depression (also cardiovascular disease & COPD) llSolzira (1838262)† voltage-gated calcium channel modulator migraine prophylaxis llSolzira (1838262)† voltage-gated calcium channel modulator neuropathic pain llalmorexant† orexin antagonist insomnia lllLamictal XR sodium channel inhibitor epilepsy – partial generalised tonic-clonic seizures, once-daily III N/A 2009retigabine† neuronal potassium channel opener epilepsy – partial seizures lllrosiglitazone XR PPAR gamma agonist Alzheimer's disease IIILunivia† non-benzodiazepine GABA agonist insomnia Submitted PO:Oct08 N/ASolzira (1838262)† voltage-gated calcium channel modulator restless legs syndrome Submitted S:Sep08 &

Jan09Lamictal XR sodium channel inhibitor epilepsy – partial seizures, once-daily Approvable N/A AL: Sep07Requip Modutab/XL† non-ergot dopamine agonist Parkinson’s disease – once-daily controlled release Approved A:Mar07 A:Jun08

formulationTreximet† 5HT1 agonist + naproxen migraine – fixed dose combination Approved N/A A:Apr08

Oncology 461364 polo-like kinase inhibitor cancer l923295† centromere-associated protein E (CENP-E) cancer l

inhibitor1120212† mitogen-activated protein kinase inhibitor cancer l

(MEK1/2)totrombopag† thrombopoietin receptor agonist thrombocytopaenia I184072 SIRT1 activator colon & haematologic cancers (also type 2 diabetes) ll1363089† mesenchymal-epithelial transition factor (C-met) papillary renal cell carcinoma, gastric cancer and head & neck ll

kinase inhibitor squamous cell carcinomapazopanib multi-kinase angiogenesis inhibitor non-small cell lung cancer llpazopanib multi-kinase angiogenesis inhibitor ovarian cancer llpazopanib + 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 IITyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (unresectable disease) llTyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory inflammatory breast cancer llAvodart 5-alpha reductase inhibitor reduction in the risk of prostate cancer lll 2009 2009elesclomol† oxidative stress inducer metastatic melanoma lllpazopanib multi-kinase angiogenesis inhibitor sarcoma lllpazopanib + Tyverb/Tykerb multi-kinase angiogenesis inhibitor + Her2 and inflammatory breast cancer lll

EGFR dual kinase inhibitorRevolade/Promacta† thrombopoietin receptor agonist chronic liver disease induced thrombocytopaenia lllRevolade/Promacta† thrombopoietin receptor agonist hepatitis C induced thrombocytopaenia lllTyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, adjuvant therapy lllTyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, first line therapy lll 2009 2009Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor gastric cancer lllTyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (resectable disease) lllDuodart (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:Dec08Zunrisa/Rezonic NK1 antagonist chemotherapy-induced & postoperative nausea & vomiting Submitted S:Jul08 S:May08Hycamtin topoisomerase l inhibitor (oral) small cell lung cancer, second-line therapy Approved A:Mar08 A:Oct07Revolade/Promacta† thrombopoietin receptor agonist idiopathic thrombocytopaenic purpura Approved S:Dec08 A:Nov08Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory breast cancer Approved A:Jun08 A:Mar07

Respiratory & 610677 p38 kinase inhibitor (inhaled) COPD lImmuno- 656933 Chemokine receptor (CXCR2) antagonist cystic fibrosis & COPD linflammation 705498 transient receptor potential vanilloid (TRPV1) non-allergic rhinitis l

antagonist (intranasal)962040 motilin receptor agonist delayed gastric emptying l1399686 anti-inflammatory macrolide conjugate (oral) inflammatory bowel disease l2245840 SIRT1 activator COPD (also type 2 diabetes) l159797† long-acting beta2 agonist COPD, also COPD & asthma in combination with a II

glucocorticoid agonist159802† long-acting beta2 agonist COPD, also COPD & asthma in combination with a II

glucocorticoid agonist256066 PDE IV inhibitor (inhaled) asthma & COPD Il573719 muscarinic acetylcholine antagonist COPD Il685698 glucocorticoid agonist asthma, also COPD & asthma in combination with a II

long-acting beta2 agonist 835726 histamine H1/H3 dual antagonist (oral) allergic rhinitis ll870086 novel glucocorticoid agonist (inhaled) asthma ll642444† long-acting beta2 agonist COPD, also COPD & asthma in combination with a ll

glucocorticoid agonist961081† muscarinic antagonist, beta2 agonist COPD ll1004723 histamine H1/H3 dual antagonist (intranasal) allergic rhinitis ll2190915† 5-lipoxygenase-activating protein (FLAP) inhibitor asthma lldarotropium muscarinic acetylcholine antagonist COPD lldarotropium + 642444† muscarinic acetylcholine antagonist + COPD ll

long-acting beta2 agonistlosmapimod (856553) p38 kinase inhibitor (oral) COPD (also cardiovascular disease & depression) llEntereg† peripheral mu-opioid antagonist post operative ileus Approved N/A A:May08

Paediatric Vaccines Mosquirix recombinant malaria prophylaxis llHib-MenCY-TT conjugated Neisseria meningitis groups C & Y disease & III 2009

Haemophilus influenzae type b disease prophylaxisMenACWY-TT conjugated Neisseria meningitis groups A, C, W & Y disease prophylaxis IIlSynflorix conjugated Streptococcus pneumoniae disease prophylaxis in infants Submitted PO:Jan09

& childrenKinrix 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 lHIV recombinant HIV infection prophylaxis lNTHi-Pneumo recombinant Streptococcus pneumoniae and Haemophilus influenzae l

disease prophylaxis in adultsS. pneumoniae adult recombinant – conjugated Streptococcus pneumoniae disease prophylaxis lDengue fever attenuated tetravalent Dengue fever prophylaxis llTuberculosis recombinant tuberculosis prophylaxis IIZoster recombinant Herpes Zoster prevention llFlu pandemic & pre-pandemic† H5N1 inactivated split – monovalent (Quebec) pandemic influenza prophylaxis lll 2009 2009New generation flu vaccine inactivated split – trivalent seasonal influenza prophylaxis for the elderly IIlSimplirix recombinant genital herpes prophylaxis lllBoostrix subunit adult booster for diphtheria, tetanus & pertussis Approved A:Jun00 A:Dec08Pandemrix (Flu pandemic)† H5N1 inactivated split – monovalent (Dresden) pandemic influenza prophylaxis Approved A:May08Prepandrix (Flu pre-pandemic)† H5N1 inactivated split – monovalent (Dresden) pre-pandemic influenza prophylaxis Approved A:May08Cervarix† recombinant human papilloma virus infection prophylaxis Approved A:Sep07 AL:Dec07

Antigen Specific WT1 recombinant treatment of acute myelogenous leukaemia lCancer MAGE-A3 ASCI recombinant treatment of melanoma lllImmunotherapeutic MAGE-A3 ASCI recombinant treatment of non-small cell lung cancer lll(ASCI)

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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 certaincountries under licence by the Group.

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 ofsuccessfully meeting the date assuming the clinical data meets the expected end-points of the clinical trials.

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 volunteersapproval letter)

Phase Il Determination of dose and initial evaluation of efficacy, conductedAL Month approvable or Complete Response letter received - in a small number of patients

indicates that ultimately approval can be given subject toresolution of outstanding queries Phase lll Large comparative study (compound versus placebo and/or

established treatment) in patients to establish clinical benefit and safetyPO Month of EU Positive Opinion

BLA Biological License Application

Page 3: GlaxoSmithKline Drug R&D Pipeline - Feburary 2009

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. 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. Forcompetitive reasons, new projects in pre-clinical developmenthave not been disclosed and some project types may not havebeen identified.

Product Development Pipeline February 2009

Phase I Phase Il Phase III Filed/Approved

315234679586belimumab†

mepolizumabofatumumab†

221149 756050184072losmapimod (856553)pazopanibremogliflozin etabonate†

rilapladib†

ronacaleret†

1349572†

IDX899†

sitamaquinetafenoquine†

239512468816561679†

649868†

681323742457firategrast†

Solzira (1838262)†

1363089†

pazopanib + Tyverb/Tykerb Revolade/Promacta†

Tyverb/Tykerb159797†

159802†

256066573719685698835726870086642444†

961081†

10047232190915†

darotropiumdarotropium + 642444†

Mosquirix (v)Dengue fever (v)Tuberculosis (v)Zoster (v)

belimumab†

ofatumumab†

otelixizumab†

Syncria†

Avandamet XRAvandia + simvastatindarapladib†

almorexant†

Lamictal XRretigabine†

rosiglitazone XRAvodartelesclomol†

pazopanibpazopanib + Tyverb/TykerbRevolade/Promacta†

Tyverb/TykerbHib-MenCY-TT (v)MenACWY-TT (v) Flu pandemic & pre-pandemic† (v)New generation flu vaccine (v)Simplirix (v)MAGE-A3 ASCI (i)

Bosatria (mepolizumab)ofatumumab†

ArixtraAvandiaVolibris†

Lunivia†

Solzira (1838262)†

Lamictal XRRequip Modutab/XL†

Treximet†

Duodart (Avodart + alphablocker)

pazopanibZunrisa/Rezonic Hycamtin Revolade/Promacta†

Tyverb/TykerbEntereg†

Synflorix (v)Kinrix (v)Rotarix† (v)Boostrix (v)Pandemrix (Flu pandemic)† (v)Prepandrix (Flu pre-pandemic)† (v)Cervarix† (v)

249320933776iboctadekin† + Doxiliboctadekin† + rituximab2560731278863129226315214981614235†

22458409321219452371265744†

1322322163090424887586529†

59880961833472932710148021018921103470211448141482160orvepitant461364923295†

1120212†

totrombopag†

6106776569337054989620401399686Cytomegalovirus (v)HIV (v)NTHi-Pneumo (v)S. pneumoniae adult (v)WT1 (i)

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Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statementsor projections made by the company, including those made in this document, are subject to risks and uncertainties that may cause actual results to differmaterially 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 ofexclusive rights, and to increase overall sales. Developing new products is a costly, lengthy and uncertain process. A new product candidate can fail at any stageof 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 commercialsuccess as a result of efficacy or safety concerns, inability to obtain necessary regulatory approvals, difficulty or excessive costs to manufacture or infringement ofpatents 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'sAnnual Report on Form 20-F for 2008.

Key

(v) Vaccine

(i) Cancer Immunotherapeutic

Page 4: GlaxoSmithKline Drug R&D Pipeline - Feburary 2009