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March 31, 2003 BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 28.4.2003 at 8.30 am INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 – MARCH 31, 2003 • In January 2003, BioTie sold its process development and manufacturing unit as part of the company’s strategy to focus on drug development. • The operating profit (loss) for the first quarter was EUR –4.3 million (in 2002, EUR –6.0 million pro forma). • The company’s liquid assets amounted to EUR 5.4 million (in 2002, EUR 9.0 million pro forma) at March 31, 2003. • After the reporting period, the company completed the first phase III clinical studies of the nalmefene tablet intended for the treatment of alcoholism. • In April 2003, the National Technology Agency (Tekes) made a conditional grant of additional funding of EUR 5.9 million for the company’s research and development programs. • After the reporting period, the company entered into a licensing agreement on the company’s VAP-1 antibody program worth USD 16.7 million with the Japanese Seikagaku Corporation. The agreement will enter into force when BioTie has completed the new issue currently being prepared and secured funding for its operations until the end of 2004. The agreement grants BioTie a signing fee of USD 2.5 million. • On April 28, 2003, The Board of Directors of BioTie Therapies decided on preparations to arrange a new issue whereby the shareholders of the company would have the pre-emptive subscription right for the new shares. With the new issue the company aims to raise EUR 10-14 million new capital primarily from company’s current shareholders by the end of June 2003. Drug development projects at the clinical phase Nalmefene (SOBERAL) for the treatment of alcoholism and alcohol abuse BioTie Therapies completed the first phase III clinical studies of the nalmefene tablet intended for the treatment of alcoholism. The studies were performed in Finland and the United Kingdom and focused on the safety and efficacy of nalmefene in the treatment of alcoholism and alcohol abuse without supporting psycho-social therapy in patients who considered themselves to be incapable of controlling their drinking. Both studies were multi-center and placebo-controlled studies. In Finland, 400 patients and in the UK, 150 patients participated in the study. The duration of drug therapy in both studies was 28 weeks. Patients were instructed to take the study drug before drinking alcohol. In the Finnish study, the number of heavy drinking days decreased almost by half in nalmefene users. In the placebo group, the number of heavy drinking days decreased by about one third and the difference between the nalmefene and placebo groups was statistically significant. In the British study, the number of heavy drinking days was also reduced by half in the nalmefene group, and the difference between the groups was in the same range as in the Finnish study. However, the difference was not statistically significant in the British study, because a higher than expected proportion of patients dropped out from the study. In both studies, the patients receiving nalmefene felt that the treatment was beneficial more often than the patients receiving placebo. No serious adverse effects related to the use of nalmefene were observed during the studies. The results demonstrate that heavy drinking can be reduced by drug therapy alone. According to its strategy BioTie seeks to out-license the project at its current development phase. The company is seeking a licensing partner, who would further develop nalmefene and bring the drug to the market. Nalmefene for the treatment of impulse control disorders The company is developing another nalmefene product for the treatment of impulse control disorders (ICD). Impulse control disorders include, for example, addictive pathological gambling, compulsive shopping, kleptomania and pyromania. Approximately 200 patients suffering from addictive pathological gambling participate in a multi-center study commenced in the United States. Preliminary results are estimated to be available during the second quarter of 2003. There is presently no drug therapy approved by pharmaceutical authorities for the treatment of impulse control disorders, and the company’s clinical product development project is the first one for developing a drug for this indication. Investigator-sponsored, small- scale studies have provided evidence that opioid antagonists are effective in the treatment of these disorders. Furthermore, it has been suggested that different dependence disorders result from the same kind of neurobiological mediation and a vicious circle of reward and enforcement as alcoholism. VAP-1 monoclonal antibody program HUVAP is a humanized (chimeric) IgG2 antibody. It has been developed in collaboration with Cambridge University, the University of Turku and Boehringer Ingelheim. HUVAP is primarily intended for the treatment of chronic inflammatory diseases such as rheumatoid arthritis. Clinical studies with HUVAP commenced at the end of September 2002. When the ongoing phase I clinical study in healthy volunteers has been completed, the company will also consider the development options of a humanized (non-chimeric) or a fully human VAP-1 monoclonal antibody. After the reporting period, on April 15, 2003, BioTie Therapies signed a regional licensing agreement on the company’s VAP-1 antibody program with the Japanese company Seikagaku Corporation. Research In glycomics research, the company continued its collaboration with Professor Karlsson’s group at the University of Gothenburg. The agreement significantly enhances the company’s ability to further strengthen its portfolio of patents in glycomics. The development of BioHeparin intended for the hemodialysis markets continues in accordance with the research and collaboration agreement with Shimizu Pharmaceuticals. BioHeparin represents a new type of drug molecule with sugar structure that has been produced by using the technology patented by the company in cooperation with the Italian company Inalco SpA. The screening and preclinical development of new alfa2beta1 integrin inhibitors continued in cooperation with the University of Turku, Åbo Akademi University and the University of Jyväskylä. A patent application for new inhibitors was submitted in the EU during the reporting period. Alfa2beta1 integrin inhibitors provide new methods for preventing thromboses caused by vascular damage as well as preventing cancer metastasis. Performance The operating profit (loss) for the reporting period was EUR –4.3 million. The corresponding figure for the previous year was EUR –6.0 million (pro forma). Research and development costs of the period amounted to EUR 3.1 million (in 2002 EUR 4.8 million, pro forma) and thus decreased by 35% from the previous year, as a result of focusing of research and development programs and rationalization of costs. In accordance with the agreement signed on January 30, 2003, the company sold its process development and production unit businesses to Biovian Oy that is owned by the management and key persons of the company and BioTie. In connection with these arrangements, a total of 14 employees, the current assets of the business, as well as business agreements and obligations were transferred to Biovian Oy as of February 1, 2003. BioTie remained a significant client and shareholder of Biovian Oy. Financing BioTie’s equity ratio was –67.4 % as at March 31, 2003 (in 2002 10.3 % pro forma). Cash and cash equivalents totaled EUR 5.4 million as at March 31, 2003 (in 2002 EUR 9.0 million, pro forma), which is sufficient for financing the company’s operations for approximately four months without income obtained from the possible commercialization of products. Investments and cash flow The company’s investments during the period amounted to EUR 18 thousand (in 2002 EUR 0.7 million, pro forma). The investments comprised of equipment for research and development operations. Cash flow before financing was EUR -4.3 million (in 2002 EUR –7.0 million, pro forma). Organization and Personnel During the reporting period, the Company's personnel was on average 85 (116 in 2002 pro forma) and at the end of the reporting period 68 (112 on 31.12.2002). The number of personnel was reduced by 44 persons during the reporting period as a result of focusing of research and development programs and rationalization of costs. Events after the reporting period Funding from the National Technology Agency (Tekes) After the reporting period, the National Technology Agency (Tekes) granted additional funding EUR 5.9 million for BioTie Therapies' drug development projects. The R&D subsidies and loans with favorable conditions granted in April cover certain drug development costs of the company from October 2002 to mid 2004. The funding granted for the development projects by Tekes varies from one project to another and covers 50-60 per cent of the costs of the projects. The share of capital loan funding of the amount now granted is EUR 4.7 million. The funding granted by Tekes is conditional on BioTie receiving in the new issue to be arranged new capital of approximately EUR 10 million for covering the self-financing share of the drug development projects. Decision of the Board of Directors to start preparation for a new issue On April 28, the Board of Directors of the company decided to start preparations to arrange a new issue whereby shareholders of the company would have the pre-emptive subscription right for the new shares. By the new issue, the company aims to raise EUR 10-14 million all new capital primarily from the company’s current shareholders by the end of June 2003. The new issue would secure covering the Tekes self-financing share as well as materialization of the VAP-1 licensing agreement with Seikagaku Corporation. An Extraordinary Shareholder’s Meeting is likely to be convened to decide on the new issue during May. Regional licensing agreement on VAP-1 antibody technology After the reporting period, BioTie Therapies entered into a licensing agreement on the company’s VAP-1 antibody program with the Japanese company Seikagaku Corporation.
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