GSK Annual Report 2002

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18 GlaxoSmithKline Description of business Compounds progressed into Phase I clinical development in 2002 During 2002 several discovery projects, listed in the table below, progressed through non-clinical safety testing and into early (Phase I) clinical development. These compounds are continuing their rigorous non-clinical, clinical and commercial assessments, leading to proof of concept decisions over the next 12–24 months. Compound Mechanism Indication 120918 + topotecan multi-drug resistance inhibitor + topoisomerase inhibitor cancer 234551 endothelin A antagonist stroke 274150 iNOS inhibitor asthma 275833 topical pleuromutilin bacterial skin infections 353162 norepinephrine/dopamine re-uptake inhibitor depression 462795 cathepsin K inhibitor osteoporosis 468816 glycine antagonist smoking cessation 485232 interleukin 18 cancer 497115 thrombopoietin agonist chemoprotection 559090 alpha4-integrin antagonist allergic rhinitis 597901 inhaled beta2 adrenergic receptor agonist asthma 640385 aspartyl protease inhibitor HIV 677954 PPAR pan agonist diabetes 679769 neurokine 1 antagonist depression 681323 p38 alpha kinase inhibitor rheumatoid arthritis 683699 dual alpha4-integrin antagonist multiple sclerosis/irritable bowel syndrome 685698 inhaled corticosteroid asthma/allergic rhinitis 695634 non-nucleoside reverse transcriptase inhibitor HIV 715992 kinesin inhibitor cancer 766994 chemokine receptor antagonist asthma 786034 VEGFR tyrosine kinase inhibitor solid tumours Lapdap + artesunate chlorproguanil/dapsone combination + artesunate malaria HIV prophylactic vaccine HIV Dengue fever vaccine vaccine Dengue fever Significant regulatory submissions in 2002 Product Country/Region Description Advair USA labelling for corticosteroid sparing effect of the combination of salmeterol, a long-acting beta-blocker, and fluticasone, a corticosteroid in a dry powder Diskus device Ariflo USA cilomilast, a PDE IV inhibitor for the treatment of chronic obstructive pulmonary disease Avandamet Europe combination of rosiglitazone and metformin for type 2 diabetes Coreg USA carvedilol, alpha/beta-blocker in-licensed from Roche for cardiac dysfunction following heart attack Flixotide Europe lower age limit for fluticasone, an inhaled corticosteroid for asthma Flovent USA CFC-free metered dose inhaler for fluticasone ibandronate Europe and USA bisphosphonate, for the treatment of osteoporosis, in-licensed from Roche Lamictal Europe and USA lamotrigine, a sodium channel blocker for long-term prophylaxis/prevention of bipolar disorder Lamictal Japan lamotrigine for epilepsy Levitra Europe PDE V inhibitor, for the treatment of erectile dysfunction, in-licensed from Bayer nesiritide Europe natriuretic peptide in-licensed from Scios Inc for acute heart failure Paxil CR USA controlled release (CR) paroxetine, a selective serotonin re-uptake inhibitor for the treatment of pre-menstrual dysphoric disorder Paxil CR USA paroxetine for the treatment of social anxiety disorder 433908 Europe and USA protease inhibitor for HIV Valtrex USA and Europe valaciclovir, a DNA polymerase inhibitor for the suppression of transmission of herpes simplex virus Wellbutrin SR USA additional sustained release (SR) strength of bupropion, a noradrenaline/dopamine re-uptake inhibitor for the treatment of depression Wellbutrin XL USA extended release (XL) formulation of bupropion for the treatment of depression.
Product approvals Country/Region Product (Approval Date) Description Description of business GlaxoSmithKline 19 In 2002, approvals were received for a number of new products, including several significant new indications and formulations for existing products, as summarised in the table below. Augmentin XR USA (October) extended release formulation of amoxicillin (a beta-lactam antibiotic) and clavulanate (a beta lactamase inhibitor) for adult respiratory tract infections Avandamet USA (October) fixed dose combination of Avandia and metformin for type 2 diabetes Avodart USA (October) 2 year data on dutasteride, a 5-alpha reductase inhibitor for the treatment of benign prostatic hypertrophy (BPH) Avodart Europe (July) dutasteride, for the treatment of BPH Epivir USA (October) once daily dosing with lamivudine, a reverse transcriptase inhibitor, for HIV Flixotide Europe (October) lower age limit for fluticasone, an inhaled corticosteroid for asthma Flonase USA (May) intranasal fluticasone for nasal symptoms Flutide Japan (October) fluticasone in a CFC-free inhaler Lotronex USA (June) reintroduction of alosetron for irritable bowel syndrome (IBS) Paxil CR USA (February) paroxetine, a selective serotonin re-uptake inhibitor for panic disorder Pediarix USA (December) combined diphtheria, tetanus, pertussis, hepatitis B and polio vaccine for children Serevent Diskus USA (March) dry powder formulation of salmeterol (a long-acting beta blocker) for COPD Serevent MDI and Diskus Japan (April) salmeterol in both metered dose and dry powder inhalers for asthma Sultanol Diskus Japan (March) the short-acting beta blocker salbutamol in a dry powder device for asthma Twinrix 2 dose Europe (September) combined vaccine for hepatitis A and B Valtrex USA (September) valaciclovir, a DNA polymerase inhibitor for the treatment of cold sores Wellbutrin SR USA (June) additional strength of bupropion for depression Zovirax cream USA (December) aciclovir, a DNA polymerase inhibitor for the treatment of cold sores Zyloric tablets Japan (March) allopurinol, a xanthine-oxidase inhibitor, for the treatment of gout R&D Processes – Discovery, Commercialisation & Delivery Genetics Research Discovery Research Intellectual property validated targets and leads Centres of Excellence for Drug Discovery "CEDDs" Pre-clinical Development New Product Development Drugs Products New Medicines of Proven Value R&D processes In line with GlaxoSmithKline's strategic intent to become the indisputable leader in the industry, R&D has set itself the goal of becoming the industry’s most productive R&D organisation. Steps to achieve this have included initiatives to both reduce the time taken in all phases of the discovery and development chain; and also to gain earlier understanding of candidate molecules, increasing the probability of making a new medicine available to treat patients as soon as possible. R&D measures this productivity not just by the number and innovation of the products it creates, but also by the commercial value of the product's ability to address the unmet needs of healthcare customers including patients, healthcare professionals, budget holders and regulators; each with their own perspective on what constitutes a valuable new product. R&D is now positioned to ensure that it generates the right safety, efficacy and quality information to respond to these different perspectives through data demonstrating the overall social benefits of the new medicine; increased length or quality of life, and increased workplace productivity. One of the historical contradictions in the pharmaceutical industry has been the need to lever the advantages of a large organisation without losing the creative spirit of the research environment. In GlaxoSmithKline, R&D has been structured to balance the areas that benefit from large scale with those that take advantage of being small to enhance their productivity. The key areas that benefit from being large are those that are capital intensive or high throughput activities such as compound screening; those that require scarce skills; and those that are highly regulated, mainly at the later end of the development chain. Other areas flourish to their best advantage if the structural unit remains small: the units can respond quickly to the changing environment; the opportunity for scientists to interact is optimised; and the need for return on investment is focussed through the fostering of an entrepreneurial, accountable culture.
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Latin America reported eight per ce
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Selected financial data UK/US GAAP
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Financial statements GlaxoSmithKlin
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Independent Auditors’ report to t
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Consolidated statement of profit an
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Consolidated statement of cash flow
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Company balance sheet at 31st Decem
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2 Accounting policies Consolidation
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6 Segment information continued Not
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7 Merger items, restructuring costs
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Notes to the financial statements G
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13 Earnings per share Notes to the
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19 Equity investments Notes to the
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30 Legal proceedings The Group is i
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31 Acquisitions and disposals conti
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32 Financial instruments and relate
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32 Financial instruments and relate
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33 Employee costs continued Notes t
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33 Employee costs continued Notes t
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34 Employee share schemes continued
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34 Employee share schemes continued
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37 Reconciliation to US accounting
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38 Principal Group companies Notes
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38 Principal Group companies contin
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Financial record GlaxoSmithKline 14
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Investor information GlaxoSmithKlin
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Shareholder information Ordinary sh
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Share capital GlaxoSmithKline 155 A
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Cross reference to Form 20-F GlaxoS
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Index A Access to healthcare 27 Acc
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Contact details INTERNET Informatio
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GSK Annual Report 2002

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