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Hansa Medical and Axis-Shield enter development and license agreement regarding novel biomarker for severe sepsis

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Hansa Medical AB (NASDAQ OMX First North: HMED) and Axis-Shield plc (LON: ASD) have entered an exclusive and worldwide agreement to develop and commercialise Hansa Medical’s proprietary severe sepsis biomarker HBP, Heparin Binding Protein.Under the collaboration, Axis-Shield will further develop the Hansa Medical prototype HBP- assay for diagnosis and monitoring of patients who are at high risk of developing severe sepsis well in advance to the onset of devastating clinical symptoms. Also, the HBP-assay will be investigated in a clinical multicenter study in order to reach regulatory market approval primarily in the US and Europe. Axis-Shield will be responsible for the development costs.Severe sepsis is a life-threatening complication to infection requiring immediate medical attention and treatment. In severe sepsis, bacteria from a local infection, often pneumonia or urinary tract infections, cause a fast drop in blood pressure and unwanted blood coagulation which leads to organ failure.Sepsis and severe sepsis are increasingly problematic, particular in intensive care units and it is estimated that there are around 8 million admissions to ICU’s per annum in Western markets. Also, millions of patients admitted to emergency departments are infectious disease patients at risk of developing severe sepsis. Severe sepsis is often lethal and in the US, more than 200,000 people die from sepsis every year However, for every hour that severe sepsis onset is anticipated with proper treatment, the survival rate increases by 7.5 percent.“We are delighted to bring this promising assay towards the market with a qualified partner like Axis-Shield.” says Emanuel Björne, CEO of Hansa Medical. Axis-Shield will add invaluable assay development capacity as well as clinical validation expertise to this project. In our initial studies at Lund University Hospital, including 300 patients, serum levels of HBP have been shown to be a promising predictor for severe sepsis, compared to inflammation markers presently on the market. Early identification of individuals at risk of developing severe sepsis is key in order to save lives and reduce treatment costs.”Ian Gilham, Axis-Shield CEO, comments: “We are pleased to have signed this arrangement with Hansa as we have been seeking an improved sepsis marker for some time. The HBP contract is part of our drive to identify and acquire rights to new markers with IP protection in areas of clinical need The urgent market requirement for better and earlier diagnosis of sepsis is well recognised and we will accelerate HBP assay development to enable test commercialisation as soon as possible”Under the terms of the agreement Hansa Medical will receive an upfront payment and development milestone payments of several million SEK. in total. In addition, Hansa Medical will receive substantial royalties from Axis-Shield on sales of HBP-assays, once the test is fully validated and launched, which is anticipated in late 2011.About Axis-ShieldAxis-Shield is an international in vitro diagnostics company, headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo. The Group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of innovative proprietary diagnostics kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. For more information on Axis-Shield, please visit www.axis-shield.comAbout Hansa MedicalHansa Medical is a preclinical and early clinical biopharmaceutical development company focused on inflammatory diseases. The company runs three primary projects, IdeS, alpha-11 and HBP. IdeS is an innovative treatment within transplantation and autoimmune diseases. Alpha-11 is a novel and specific rheumatoid arthritis drug target. HBP, Heparin Binding Protein, is a novel biomarker for diagnosis of severe sepsis. Hansa Medical is publicly traded at NASDAQ OMX First North under ticker symbol HMED. For more information on Hansa Medical, please visit www.hansamedical.comFor more information, please contact:Hansa Medical AB (publ)Emanuel Björne, CEO Hansa Medical ABTelephone: +46 707 175477E-mail: emanuel.bjorne@hansamedical.com Axis-Shield plcIan Gilham, CEO Axis-Shield plcTelephone:+44 (0)203 178 7849

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