FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation

Hansa Medical AB (publ) today announced that the US Food and Drug Administration
(FDA) has completed the safety review of the company’s Investigational New Drug
application (IND) and has concluded that the proposed clinical investigation can
proceed. This enables Hansa Medical to start a clinical study to primarily
evaluate IdeS’ efficacy in making highly sensitized kidney patients with
positive crossmatches eligible for transplantation by removing donor specific
antibodies. The clinical trial is scheduled to begin soon.
The single arm study will include up to 20 kidney transplantation patients that
have either failed on previous attempts of desensitization or in whom effective
desensitization using currently available methods is highly unlikely. The trial
is scheduled to begin soon at reputable medical institutions in the US, with the
aim to complete recruitment during the first half of 2017.

"Following the encouraging results in the on-going trials conducted by Professor
Gunnar Tufveson at Uppsala University Hospital and Professor Stanley Jordan at
Cedars-Sinai Medical Center, respectively, we are excited to begin this US trial
with Hansa Medical as sponsor, investigating IdeS in highly sensitized
patients", said Göran Arvidson, President and CEO of Hansa Medical AB.

"FDA clearance of the IdeS IND is a milestone for the company defining a
potential path toward product approval."

The first trial to be conducted under this IND is titled "A Phase II Study to
Evaluate the Efficacy of IdeS (IgG endopeptidase) to Desensitize Transplant
Patients with a Positive Crossmatch Test". The primary objective is to assess
IdeS’ efficacy in creating a negative crossmatch test. The trial will also
evaluate the safety, kidney function and immunogenicity during the 6-month
follow-up period.

The information in this press release is disclosed pursuant to the Swedish
Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The
information was released for public disclosure on April 4, 2016 at 08.00 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About IdeS
IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically
cleaves human IgG antibodies. During 2013, a Phase I clinical trial including 29
healthy subjects was conducted, demonstrating IdeS as efficacious and well
tolerated with a favorable safety profile. During 2014, a Phase II study in 8
sensitized patients awaiting kidney transplantation was conducted. Data from the
study show that IdeS is effective in reducing anti-HLA antibody levels in highly
sensitized patients to levels acceptable for transplantation. IdeS is currently
investigated in two on-going clinical trials in sensitized kidney patients in
Sweden and in the US. The trials will involve 20-30 patients in total and the
objective is to investigate IdeS’ efficacy and safety. 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 scientific journals.

About Hansa Medical AB
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 and rare autoimmune diseases.
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.