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Hansa Biopharma
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Hansa Biopharma

Well attended Capital Markets Day by Hansa Medical

13 Nov 2015, 17:00
Regulatory information
Biopharma Company Hansa Medical AB (publ), listed on Nasdaq Stockholm’s main list (ticker: HMED), held today, November 13, 2015, a Capital Markets Day at Royal Swedish Academy of Engineering Sciences (IVA) in Stockholm.

Hansa Medical's CEO Göran Arvidson welcomed everyone to the company's first Capital Markets Day. On the podium were also some of the world's top experts in the field of importance to Hansa Medical´s clinical program.

Professor Lars Björck at Lund University spoke about the discovery and the initial research on Hansa Medical's leading clinical project IdeS, currently in Phase II clinical trials for the treatment of sensitized kidney transplant patients.

Hansa Medical’s CSO, Dr. Christian Kjellman, gave a scientific overview of IdeS and its possible indication landscape, including transplantation and acute autoimmune diseases, while Emanuel Björne, Director, Corporate Development and Investor Relations, spoke about IdeS potential patient population.

The well-reputed transplantation experts Professor Stanley Jordan at Cedar-Sinai Medical Center in Los Angeles, Professor Robert A. Montgomery at Johns Hopkins in Baltimore, and Professor Gunnar Tufveson at Uppsala University Hospital described the difficulties in transplanting sensitized patients, how the antibodies affect the patient's ability to be transplanted, as well as their own experience of desensitization with plasma exchange and IVIg / anti-CD20 treatment.

Dr. Tufveson furthermore disclosed that to date five patients in the current Swedish phase II study have been transplanted.

Dr. Tufveson and Dr. Jordan gave their views of how they have worked actively with IdeS in connection with kidney transplantation and clinical phase II trials, and how IdeS might improve the quality of life for sensitized patients currently on dialysis. Dr. Jordan furthermore disclosed data from a patient with a PRA level of 100% treated with IdeS and transplanted successfully at Cedars-Sinai in July this year.

Dr. Montgomery described the desensitization and intervention methods currently in use and underlined the fact that patients who are transplanted in association with current regimes “have always been in the presence of antibodies”. However, IdeS has proved to be extremely effective in lowering the antibody presence to negligible levels in patients with high titer antibodies.

Lena Winstedt and Steven Glazer – CRD and CMO respectively at Hansa Medical - specified how the company has projected its ongoing and planned studies of IdeS within transplantation and autoimmune diseases.

Emanuel Björne, Hansa Medicald´s Director Corporate Development and Investors Relations,

Informed about HBP-assay and the partnership with Axis-Shield Diagnostic. Axis-Shield is aiming at launching a clinical chemistry version of the HBP-assay during first half of 2016.

"Hansa Medical has over the last year passed a number of important milestones, both scientifically, financially and organizationally. This is an excellent opportunity for us to provide a better picture of where the company is and where we are heading. It is a valuable opportunity to communicate with shareholders and the market and we plan to schedule in similar briefings in the future”, said Göran Arvidson.

The videotaped presentations from the Capital Markets Day will be posted on www.hansamedical.com shortly.

The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on November 13, 2015, at 17.00 CET.

For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com

About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS aims to degrade immunoglobulin G (IgG) and has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a Phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. During 2014, a Phase II study in 8 sensitized patients awaiting kidney transplantation was conducted. Preliminary data show that IdeS is effective in reducing anti-HLA antibody levels in highly sensitized patients on the kidney transplant waitlist. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to levels acceptable for transplantation. In addition to transplantation, IdeS has potential applications in a variety of rare autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed medical and scientific journals.

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on First North Premier in Stockholm with Remium Nordic AB as Certified Adviser.