Giannis Pachis, Excommunication, 1997 Unlike controlled clinical trials, the EPOS project has been designed as a so-called naturalistic study. Naturalistic studies are of great importance within medical epidemiology because their observational nature does not affect the treatment of the patients. Only naturalistic data, describing the patients treatment and the doctors clinical practice, will be collected. The study will thus give a more realistic and objective picture of the daily treatment situation than a controlled clinical trial can provide. The patients will receive their medicine in the usual way (e.g. from a chemists shop or at a hospital) and will take the dose that is recommended in normal psychiatric practice. The EPOS project comprises two independent cohorts of schizophrenic patients; a Serdolect cohort (4,000 patients) and a reference cohort (8,000 patients). The Serdolect cohort consists of schizophrenic patients whose doctors have decided to prescribe Serdolect®/Serlect® as part of the normal therapeutic regime. The reference cohort consists of randomly selected schizophrenic patients who are identified via the drawing of lots principle without use of clinical selection criteria. This has been done in order to ensure objective selection of a representative cohort of schizophrenic patients. Doubling the clinical database The EPOS project aims to double the clinical database for Serdolect-treated patients. The plan is to recruit the 12,000 schizophrenic patients from around 400 centres in 13 European countries. Each patient will be followed for a period of at least one year, i.e. for a further 12 months if the patients antipsychotic treatment is changed during the first 12 months. The project is being sent to relevant ethics committees in the individual countries. By including twice as many patients in the reference cohort as in the Serdolect cohort, it will be possible to identify sub-groups with common characteristics in the two cohorts with a view, for example, to comparing sub-groups of patients without cardiovascular diseases at the start of the study. It will also be possible to identify a number of causes of hospitalisation of schizophrenic patients and to determine whether there is any relationship between hospitalisation and their antipsychotic treatment or whether the hospitalisation is a natural consequence of their disease. Pharmaco-economic data, measured as the number of days of hospitalisation, will be evaluated within each cohort and between selected sub-groups. The EPOS project will also be able to describe how psychiatrists treat their patients - for example, how often they have personal contact with them, including what medicinal and other supportive treatment the patients receive. This information will throw light on differences and similarities in therapeutic principles between different European countries and their consequences for the patients welfare. By following Serdolect-treated patients under market conditions, we will be able to see whether the various sections in the product information for Serdolect®/Serlect® (e.g. on contraindications and precautions in use) are actually followed, so that the right patient groups get the optimal benefit from the drug. Recruitment Recruitment of patients commenced in the UK in July 1997. The other countries are Austria, Denmark, Finland, Germany, the Netherlands, Ireland, Greece, Italy, Spain, Norway, Belgium and Switzerland, and in most of these, recruitment of patients has already begun. A full-time project team has been put together in International Clinical Research, whose employees are responsible for implementation of the EPOS project, including initiation, monitoring, collecting and analysis of data, and quality control. An independent committee composed of external clinical experts within psychiatry, cardiovascular diseases, clinical pharmacology and biostatistics has also been set up. In collaboration with Lundbeck, this committee will be responsible for critically reviewing all data on the basis of a scientific, safety and ethical perspective. Data procured in connection with the EPOS project will be reported at regular intervals to the health authorities in the countries in question and will be published in international scientific journals. 31 Contents Supervisory Board and Board of Management A clear vision The way forward A continuously dev Supervisory Board Arne V. Jensen (Chairman) Jørgen Fakstorp (Vice-Chairman) Lars Bruhn Henrik He Board of Management Erik Sprunk-Jansen President Eva Steiness Executive Vice President Research an Georgios Peros, Abstract, 1990 A clear vision Lundbeck has a clear vision. We intend to become one The way forward Strategy is planning - the ability to see where we are, where we are going and how A visionary goal Our goal is to become one of the worlds leading companies in the treatment of psych A continuously developing organisation Lundbeck is a continuously developing company. Growing inter Group structure The Lundbeck Foundation H. Lundbeck A/S Synthesis factories Region Scandinavia &am The pharmaceutical industry Market conditions in the pharmaceutical industry In 1996, the global ph K. Nathanael, Sunset, 1997 Sales and marketing The sales figure for 1997 places Lundbeck as one of Lundbecks products Lundbecks research and development activities are concentrated on developing new Koprianos, Town, 1996 Lastly, Lundbeck has a promising substance under development for treatment of The Supervisory Boards Report Net turnover (DKKm) 3,000 2,662 Net turnover 2,500 2,000 1,500 1,000 During the last few years, the pharmaceutical industry has undergone marked changes, resulting in a The Supervisory Boards Report Average number of employees 2,500 Subsidiaries Parent companies 2,000 At the annual general meeting on 16 May 1997, the employee bonus/profit distribution scheme that had The Supervisory Boards Report Lundbeck International Psychiatric Institute As a specialist in psych Spyros Loukidis, Windows, 1995 17 Environmental Report The Managements Declaration Lundbeck regards openness about the companys healt Environmental Report 1997 In 1997, Lundbeck continued developing a health, safety and environmental Environmental Report Lundbeck - general Lundbeck has its headquarters, with its management, adminis K. Fyra, Abstract, 1994 The first steps in the process are often carried out in Seal Sands, while t Environmental Report Summary of the Groups environmental status Below a short summary is given of t the waste water, while the remaining approx. 1,200 tonnes are sent to a special chemical waste dispo The Lundbeck International Psychiatric Institute The Lundbeck International Psychiatric Institute Ex ment, education of patients and their families, and Quality Management within psychiatric treatment. Art can overcome prejudices In Greece, as in many other countries, the general attitude to psychiat Giannis Papadakis, Abstract, 1997 Strengthening local collaboration The exhibitions are held in col PsychiatryLink an Internet introduction http://www.psychiatrylink.com will give you the possibility Lundbeck presents http://www.psychiatrylink.com The development of the first version of Lundbecks ne EPOS EPOS: European Post-marketing Observational Serdolect®/Serlect® project: increasing our unders Giannis Pachis, Excommunication, 1997 Unlike controlled clinical trials, the EPOS project has been My dream changes from colour to black and white Depression is about the worst thing anyone can exper The pieces fall into place That was the start of a life with changing psychopharmacological drugs, a Lundbeck worldwide Parent company H. Lundbeck A/S Ottiliavej 9 DK-2500 Copenhagen - Valby Tel: +45 Slovenia Lundbeck Pharma AS Presernova 1 (2. nadstropje) SLO-2000 Maribor Tel/Fax: +386 62 221 943 R The Lundbeck Foundation Award for Outstanding Research The Lundbeck Foundation, which makes substant V. Kafivas, Garden, 1996 Accounts 37 Summary for the Group 1993-1997 Profit and loss account (DKKm) Net turnover Profit before R&D c Key figures Average number of employees Average number of shares (million)*) Earnings per share (DKK Comments on the accounts Profit for the year In 1997, profit developed positively. Profit for the y The limited effect of the policy changes in 1997 is due to the movement in the size and composition Comments on the accounts Under the changed accounting policies, the results of foreign subsidiaries At the end of 1997, Lundbecks new antipsychotic drug, Serdolect®/Serlect®, had been launched in 10 E Comments on the accounts Other operating income, net Other operating income, net, amounted to DKK 8 In 1997, capital investments totalled DKK 188 million against DKK 224 million in 1996. As in 1996, t Financial comments General In 1997, the Lundbeck Groups financial income and expenses were affected The Groups loans on mortgage credit-like terms at 31 December 1997 Outstanding debt CIBOR-based loan Financial comments At the present moment it is very likely that Italy, Spain and Portugal will also Lundbecks exchange rate index (1988 = 100) 104 102 100 98 96 94 92 90 88 (Jan.) 89 90 91 92 93 94 95 Accounting policies General The annual accounts and the consolidated accounts have been prepared in The consolidated accounts are prepared on the basis of the accounts of the parent company and the su Accounting policies Provision is made in the balance sheet for the present value of plans which are The cost of new buildings and erection by the company of its own technical installations and machine Profit and loss account for the year ended 31 December 1997 Parent company 1996 DKKm 1,411.1 503.6 Per share ratios (DKKm) 150 137 Net asset values Cash flow 125 100 80 82 114 Earnings per share Balance sheetat Assets Parent company 1996 DKKm 18.0 9.6 27.6 386.1 140.4 101.5 146.6 774.6 95.4 5. Balance sheetat Liabilities Parent company 1996 DKKm 110.0 56.1 1,086.2 1,252.3 1997 DKKm 110.0 77. Statement of sources and application of funds for the year ended 31 December 1997 Group Notes Oper Signatures Copenhagen, 12 March 1998 The Supervisory Board and the Board of Management have today c Notes to the profit and loss account 1 Net turnover Parent company 1996 DKKm 263.0 874.7 176.9 96.5 Production, distribution, administration, and research and development costs incl. depreciation etc. Notes to the profit and loss account 4 Other operating income Parent company 1996 DKKm 3.1 3.1 1997 6 Tax on the profit for the year Parent company 1996 DKKm 1.3 0.8 1997 DKKm 49.7 - 0.1 Tax due on th Notes to the balance sheet 7 Intangible and tangible fixed assets Group: Research and development c Land and buildings DKKm Technical plant and machinery DKKm Other fixtures and fittings, tools and Notes to the balance sheet 8 Shares in subsidiaries Total DKKm Book value at 1.1.1997 Adjustment du 8 Shares in subsidiaries - continued Net asset value at 31.12.1997 DKKm H. Lundbeck A/S, Norway H. L Notes to the accounts 9 Other shareholdings and other receivables Parent company Other shareholding 11 Capital and reserves Group 1996: Share capital DKKm Capital and reserves at 1.1.1996 Adjustment d Notes to the accounts 11 Capital and reserves - continued Parent company 1996: Share capital Revalu 12 Provisions for pensions Group: The Group operates with two types of pension plans: defined contri Notes to the accounts 13 Provisions for deferred tax Group: Temporary differences between calculati 13 Provisions for deferred tax - continued Parent company: Temporary differences between calculation Notes to the accounts 15 Contractual obligations Rentals and leasing obligations Lundbeck has commi Notes to statement of sources and applicational funds 17 Adjustments Group: 1997 DKKm Depreciation e Michalis Manolopoulos, Landscape, 1997 Lundbecks new logo Lundbeck has introduced a new logo that clearly expresses our identity, vision an