First patient treated with IdeS in Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP)

Hansa Medical AB (publ) today announced that the first patient has been
recruited and treated in a Phase II clinical study with IdeS in the acute
autoimmune disease acquired Thrombotic Thrombocytopenic Purpura (TTP) at
University College Hospital in London.
Acquired TTP is a severe and acute autoimmune blood disorder in which the
presence of autoantibodies can result in systemic life threatening micro
-clotting in vital organs. The Hansa Medical-sponsored study with IdeS in TTP is
an open-label study to evaluate the safety, tolerability, efficacy,
pharmacodynamics and pharmacokinetics of IdeS in asymptomatic patients with
acquired TTP.

The patients in the study will have low ADAMTS13 activity. ADAMTS13 is a
significant component in the coagulation system. An important goal of the study
is to investigate if one dose of IdeS results in increased ADAMTS13 activity by
cleaving ADAMTS13 autoantibodies. The Clinical Investigator, Dr. Marie Scully,
consultant haematologist at UCLH, is a leading expert in patient care and
clinical research in TTP.

The study will include up to six patients with acquired TTP and low ADAMTS13
activity who are asymptomatic at the time of enrolment into this study. The
study is expected to be completed during 2017.

“This novel therapy, initially investigated to determine safety and efficacy,
could provide an innovative treatment for acute TTP, clearing the antibodies
against ADAMTS 13, aiding response to remission and reducing morbidity and
mortality”, says Dr. Scully, who is supported by the National Institute for
Health Research University College London Hospitals Biomedical Research Centre.

“We are happy to now announce our progress into the autoimmune space through the
initiation of this explorative Phase II trial with IdeS in acquired TTP. The
effective and fast IgG-cleaving mode-of-action of IdeS makes it highly relevant
to evaluate the efficacy and safety of IdeS in this potentially devastating
acute condition“, says Göran Arvidson, CEO of Hansa Medical AB.

The information in this press release is disclosed pursuant to the EU Market
Abuse Regulation. The information was released for public disclosure through the
agency of Göran Arvidson stated below on October 11, 2016 at 08.30 CET.
For further information, please contact:
Emanuel Björne, Vice President Business Development and Investor Relations,
Hansa Medical AB (publ)
Mobile: +46707175477
E-mail: emanuel.bjorne@hansamedical.com

Göran Arvidson, CEO
, Hansa Medical AB (publ)
Mobile: +4670633 3042
E-mail: goran.arvidson@hansamedical.com
About acquired TTP
Acquired TTP is an ultra-rare, acute, auto-immune blood clotting disorder,
affecting 1/100,000 inhabitants. It has a sudden onset caused by impaired
activity of the ADAMTS13 enzyme (typically <10% of that in plasma of healthy
individuals), leaving ultra-large Von Willebrand Factor (vWF) molecules un
-cleaved (vWF is an essential protein involved in the blood clotting process).
These ultra-large vWF molecules bind to blood platelets, resulting in severe
thrombocytopenia (very low platelet counts) and formation of micro-clots in
small blood vessels throughout the body. Acquired TTP is associated with severe
morbidities of the brain, heart and kidney and affects life expectancy and
quality of life. Mortality is high at 10-15% within 2 weeks after initial
diagnosis. Moreover, the risk of recurrences is high in patients with
persistently low levels of ADAMTS13 after treatment with the current standard of
care, which consists of daily plasma exchange and immune-suppressants.

About IdeS

IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically
cleaves human IgG antibodies. IdeS has been evaluated in a Phase I study in
healthy subjects and in a Phase II study in sensitized patients awaiting kidney
transplantation demonstrating that IdeS is highly effective in reducing anti-HLA
antibodies to levels acceptable for transplantation with a favorable safety
profile. The efficacy and safety of IdeS in transplantation are currently
investigated in three on-going Phase II studies in sensitized kidney patients in
Sweden and the US. In addition to transplantation, IdeS has potential
applications in a variety of rare autoimmune diseases and currently, the
efficacy and safety of IdeS are investigated in a Phase II study in acquired
Thrombotic Thrombocytopenic Purpura.

About Hansa Medical AB (publ)
Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory
enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical
development, with potential use in transplantation, rare autoimmune diseases and
oncology. Additional projects focus on development of new antibody modulating
enzymes, as well as HBP, a diagnostic biomarker for prediction of severe sepsis
at emergency departments that is already introduced on the market. The company
is based in Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on
Nasdaq Stockholm.

About UCLH
UCLH (University College London Hospitals NHS Foundation Trust), situated in the
West End of London, is one of the largest NHS trusts in the United Kingdom and
provides first-class acute and specialist services. The state-of-the-art
University College Hospital which opened in 2005, is the focal point of UCLH
alongside four cutting-edge specialist hospitals. UCLH is committed to research
and development and forms part of UCL Partners which in March 2009 was
officially designated as one of the UK's first academic health science centres
by the Department of Health. UCLH works closely with UCL, translating research
into treatments for patients. For more information, visit: www.uclh.nhs.uk,
Facebook (UCLHNHS), Twitter (@UCLH) or Youtube (UCLHvideo).