BioInvent and Lund University present data on significant plaque reduction in blood vessels

Lund, Sweden: The results from animal tests on BioInvent International AB’s (SAX:BINV) drug candidate, BI-204, for the treatment of atherosclerosis were presented this weekend at the American Heart Association’s annual medical conference in Dallas. The results show that the drug candidate significantly impedes plaque formation and greatly reduces the size of plaques that already exist.

The presentation described research carried out at the University Hospital MAS in Malmö, part of Lund University, led by Professor Jan Nilsson and conducted in cooperation with BioInvent. Professor Nilsson and his team studied the effect of BioInvent’s drug candidate, BI-204, on the atherosclerosis process. The preclinical results demonstrated that: • BI-204 impedes the synthesis and release of pro-inflammatory signal substances and reduces the level of macrophages, a type of immune cell in plaques. This reduces inflammation in the plaques and is believed to be an important factor in stabilising plaques that are at risk of breaking apart. • BI-204 reduces plaque formation in the vessels by more than 50 per cent after 4 weeks of treatment, compared to a control test using a placebo. • BI-204 also reduces the size of plaques that already exist by more than 50 per cent after 4 weeks of treatment, compared to a placebo. • The results are dose-dependent; the effect increases as the amount of the drug administered is increased. BI-204 is a human antibody selected from BioInvent’s n-CoDeR antibody library. The antibody binds to an oxidised form of the LDL blood lipid, also known as ”bad” cholesterol. Research carried out by Professor Jan Nilsson at Lund University and Professor P.K. Shah at Cedars-Sinai Medical Center in Los Angeles has shown a strong connection between this form of LDL and plaque formation. BI-204 is intended to stabilise the plaques and reduce their size, thereby lowering the risk of myocardial infarction and stroke. The right to use oxidised forms of LDL (for which patents are pending) as target proteins were licensed by BioInvent in December 2002. BioInvent has started preparations for the BI-204 toxicology studies. The first stage of clinical development will focus on patients that run a high risk of myocardial infarction or stroke. Such a group of patients are individuals that already have suffered a myocardial infarction and that are likely to have more unstable plaques that may break apart and cause another infarction. In the five largest pharmaceutical markets in the world, the number of individuals that have survived an infarction is around 16 million. A drug that can offer a preventive treatment to those patients at high risk will meet a great medical need. ”The research results show that antibody drugs targeting oxidised LDL have the potential to impact and control the atherosclerosis process. If this data can be reproduced in humans, there is a strong possibility that a drug can be developed with the potential to help many patients,” says Professor Jan Nilsson. ”We are grateful for the opportunity to share our data at the American Heart Association’s annual medical conference, one of the most important gatherings in the cardiovascular field. With these promising results, we are very enthusiastic about the opportunity of taking this drug candidate into the clinical phase,” says BioInvent’s President and CEO, Svein Mathisen. -- THE END -- For more information BioInvent International AB Svein Mathisen President and CEO Phone: +46 (0)46 286 85 67 Mobile: +46 (0)708 97 82 13 E-mail: svein.mathisen@bioinvent.com Cristina Glad Executive Vice President Phone: +46 (0)46 286 85 51 Mobile: +46 (0)708 16 85 70 E-mail: cristina.glad@bioinvent.com Lund University Jan Nilsson Professor Tel: +46-(0)40-33 76 84 E-mail: Jan.Nilsson@medforsk.mas.lu.se Northbank Communications Katja Stout/Christelle Kerouedan Phone: 020 7886 815 E-mail: c.kerouedan@northbankcommunications.com Legal disclaimer This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual out-come may deviate significantly from the scenarios described in this press release. Notes to editors: Atherosclerosis is characterised by stenosis of the blood vessels and occurs when cholesterol is deposited on the inside of the vessel walls causing plaque formation. The plaque nar¬rows the blood vessels and impedes the blood flow. This condition can lead to angina pectoris. If the plaque breaks apart, a thrombosis or blood clot will form which can block the blood vessel entirely or break away and be carried away by the blood flow. Such a blood clot may lodge in the heart causing infarction and if it reaches any of the blood vessels in the brain, it will cause a stroke. Development of atherosclerosis may begin early in a person’s teens, although the symptoms often do not appear until 30 or 40 years later. The figure grows as people get older, but it is hard to accurately calculate how many people are actually affected, since atherosclerosis may be present without any visible symptoms until the onset of the acute stage. These cardiovas¬cular diseases are responsible for about half of all deaths in the west¬ern world today. BioInvent International AB, which is listed on the O list of the Stockholm Stock Exchange (SAX:BINV), develops therapeutic antibodies against diseases where there is a significant unmet medical need. Antibodies are a strongly growing segment of the pharmaceutical market. BioInvent focuses on discovery and development of therapeutic antibodies, and documents their effect in pre-clinical and early clinical trials. Clinical development, marketing and distribution are conducted in cooperation with established pharmaceutical companies. Today BioInvent conducts innovative drug projects involving conditions such as HIV infection, thrombosis, cancer, atherosclerosis and diseases of the joints. These projects are based on a competitive technology platform that covers the entire chain from the n-CoDeR? antibody library for fast and efficient selection of human antibodies, to production in a facility fully approved for manufacturing biological drugs. The scope and strength of this platform is also utilised by partners in the development of new drugs. These partners include ALK-Abelló, Antisoma, Celltech, GlaxoSmithKline, Igeneon, ImmunoGen, OrbusNeich, Syngenta and XOMA. The Company, which currently has 92 employees, is located at Ideon in Lund. BioInvent International AB (publ) Co. reg. No. 556537-7263, Address: Sölvegatan 41 Mailing address: 223 70 LUND Tel: +46 (0)46 286 85 50 info@bioinvent.com www.bioinvent.com