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Product Development Pipeline February 2008 Therapeutic area
Compound/Vaccine
Indication
Estimated
submission dates
Cardiovascular
Cardiovascular projects
& Metabolic
atherosclerosis (also chronic obstructive pulmonary disease – COPD, neuropathic pain & rheumatoid arthritis) atherosclerosis (also COPD, depression & rheumatoid arthritis) ll Metabolic projects
remogliflozin etabonate
sodium dependent glucose transport (SGLT2) Infectious Diseases
Musculoskeletal,
Inflammation,
Gastrointestinal
& Urology
age-related macular degeneration (also cancer indications) 3G-selective oestrogen receptor modulator rheumatoid arthritis (also atherosclerosis, COPD rheumatoid arthritis (also atherosclerosis, COPD & depression) II corticotrophin releasing factor (CRF1) antagonist irritable bowel syndrome (also depression & anxiety) reduction in the risk of prostate cancer 5-alpha reductase inhibitor + alpha blocker benign prostatic hyperplasia – fixed dose combination hypereosinophilic syndrome (also severe asthma & nasal rheumatoid arthritis (also cancer indications) Neurosciences
triple (5HT/noradrenaline/dopamine) re-uptake neuropathic pain (also atherosclerosis, COPD & rheumatoid depression (also atherosclerosis, COPD & rheumatoid arthritis) ll depression & anxiety (also irritable bowel syndrome) depression & anxiety (also as Zunrisa/Rezonic for IIchemotherapy-induced & postoperative nausea & vomiting) epilepsy – partial generalised tonic-clonic seizures, once-daily epilepsy – partial seizures, once-daily Parkinson’s disease – once-daily controlled release Oncology
papillary renal cell carcinoma, gastric cancer and head & Armala (pazopanib) + Tykerb multi-kinase angiogenesis inhibitor + ErbB-2 and epidermal growth factor receptor(EGFR) dual kinase inhibitor Armala (pazopanib) + Tykerb multi-kinase angiogenesis inhibitor + ErbB-2 head & neck squamous cell carcinomas (unresectable disease) Armala (pazopanib) + Tykerb multi-kinase angiogenesis inhibitor + ErbB-2 refractory chronic lymphocytic leukaemia (also rheumatoid refractory follicular lymphoma (also rheumatoid arthritis) long-term idiopathic thrombocytopaenic purpura head & neck squamous cell carcinomas (resectable disease) chemotherapy-induced & postoperative nausea & vomiting short-term idiopathic thrombocytopaenic purpura small cell lung cancer, second-line therapy Respiratory
histamine H1/H3 dual antagonist (intranasal) 5 lipoxygenase activating protein (FLAP) inhibitor respiratory diseases COPD, also COPD & asthma in combination with a COPD, also COPD & asthma in combination with a COPD, also COPD & asthma in combination with a COPD (also atherosclerosis, neuropathic pain & asthma, also COPD & asthma in combination with a long-acting beta2 agonist (also as Avamys/Veramyst forallergic rhinitis) COPD (also atherosclerosis, depression & rheumatoid arthritis) II severe asthma & nasal polyposis (also hypereosinophilic Paediatric Vaccines
Neisseria meningitis groups C & Y disease & Haemophilus influenzae type b disease prophylaxis Neisseria meningitis groups A, C, W & Y disease prophylaxis diphtheria, tetanus, pertussis & poliomyelitis prophylaxis Streptococcus pneumoniae & non-typeable Haemophilus influenzae disease prophylaxis for children rotavirus-induced gastroenteritis prophylaxis Other Vaccines
Streptococcus pneumoniae disease prophylaxis H5N1 inactivated split – monovalent (Quebec) H5N1 inactivated split – monovalent (Quebec) seasonal influenza prophylaxis for the elderly adult booster for diphtheria, tetanus & pertussis H5N1 inactivated split – monovalent (Dresden) H5N1 inactivated split – monovalent (Dresden) human papilloma virus infection prophylaxis Antigen Specific
Immunotherapeutic
(ASCI)
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.
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 USA, which is used in certaincountries under licence by the Group.
Product Development Pipeline February 2008 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 remoglifozin etabonate (189075)† darapladib† Armala (pazopanib) + Tyverb/Tykerb In-license or other alliance relationship with third party Subject to completion of ongoing regulatory discussions Date of first regulatory approval (for MAA, this is the first EUapproval letter) Date approvable or Complete Response letter received - indicates that ultimately approval can be given subject to resolution of Marketing authorisation application (Europe) Epstein-Barr virus (v)†Hepatitis E (v)† Evaluation of clinical pharmacology, usually conducted involunteers Tuberculosis (v)Varicella Zoster virus (v) Determination of dose and initial evaluation of efficacy,conducted in a small number of patients Phase III Large comparative study (compound versus placebo and/or established treatment) in patients to clinical benefit and safety 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 forward-lookingstatements or projections made by the company, including those made in this document, are subject to risks and uncertainties that may cause actual resultsto 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 expirationof exclusive rights, and to increase overall sales. Developing new products is a costly, lengthy and uncertain process. A new product candidate can fail at anystage 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 commercialsuccess as a result of efficacy or safety concerns, inability to obtain necessary regulatory approvals, difficulty or excessive costs to manufacture orinfringement of patents or other intellectual property rights of others or inability to differentiate the product adequately from those with which itcompetes.
Other factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in thecompany's Annual Report on Form 20-F for 2007.

Source: https://www.gsk-korea.co.kr/media-files/gsk-pipeline-feb08.pdf