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Year-End Release 2008

10 Feb 2009, 08:00
Regulatory information

Biotech company Hansa Medical develops biological pharmaceuticals for treatment of autoimmune diseases and transplantation rejection. The company is pursuing two development projects, IdeS and alpha-11, and is evaluating new candidate drugs and drug targets for treatment and diagnostics of inflammatory diseases. Hansa Medical is listed on NASDAQ OMX First North and Remium AB is the company’s certified advisor.This document is a summary of the full Swedish report. For a full account of the company’s operations, refer to the Swedish report.Financial information• Net sales for the Group amounted to SEK 0.1 M• The loss for the Group was SEK 2.6 M• The operating loss for the Group totaled SEK 15.9 M• Loss per share was 0,67Year in brief• During 2008, Hansa Medical conducted in-house development of production methods for IdeS and these methods are now ready to be transferred to GMP facility.• Research results for IdeS and EndoS were published. The results describe the compounds’ potential as protein drugs for treatment of autoimmune diseases and in conjunction with transplantation. • Acquisition and development of alpha-11 project, a novel and more specific drug for treatment of rheumatoid arthritis. The acquisition strengthens Hansa Medical’s patent portfolio and expertise in the field of biological pharmaceuticals and inflammatory joint diseases. • Patent protection relating to alpha-11 was improved during the year. In the US, the patent for alpha-11 was granted and Hansa Medical received a preliminary response that the corresponding patent requirement will be granted in Europe.• Considerable interest among potential partners for alpha-11 as an alternative to anti-TNF alpha treatment of patients with rheumatoid arthritis. Negotiations relating to partnerships are in the final stages. CEO’s comments – focus on IdeS and alpha-11“The IdeS project is being pursued with full vigor toward the goal of implementing a clinical Phase IIa trial. Extensive in-house process development has been conducted and we will now transfer process and analytical methods to a contract producer for the production of clinical material.”“At the beginning of 2008, we acquired the rheumatoid arthritis project alpha-11. The need for and interest in a more specific method for treatment of rheumatoid arthritis is considerable in the medical and biotechnology industries. We recruited employees with vast expertise in antibody-based pharmaceuticals and strengthened the patent portfolio surrounding alpha-11. The focus of the development plan remains to validate alpha-11 as a drug target to achieve an optimal commercial situation to out-license the drug.” Emanuel Björne, CEO Hansa Medical AB (publ)For further information, please contact:Emanuel Björne, CEOMobile: +46 (0)707-17 54 77E-mail: emanuel.bjorne@hansamedical.comBo Håkansson, Chairman of the BoardMobile: +46 (0)705-98 57 22 E-mail: boh@farstorp.com