Hansa Medical receives FDA Orphan Drug Designation for IdeS

Hansa Medical today announced that the U.S. Food and Drug Administration (FDA)
has granted orphan drug designation (ODD) to IdeS for the prevention of antibody
mediated organ rejection in solid organ transplant patients. More information
about the ODD has been posted on www.fda.com
Approximately 30 percent of the patients on the waiting lists for kidney, heart,
lung and pancreas, equivalent to approximately 35 000 patients in the US, are
sensitized to Human Leukocyte Antigen (HLA). HLA sensitization is a risk factor
in transplantation and a significant part of the sensitized patients are rarely
considered for transplantation due to the increased risk of antibody mediated
organ rejection. Hansa Medical currently conducts Phase II trials with candidate
drug IdeS for the prevention of antibody mediated organ rejection in kidney
transplant patients.

“We are pleased to receive orphan designation for IdeS in the US as HLA
sensitization constitutes a significant barrier for transplantation for
thousands of patients annually. We believe that IdeS has the potential to enable
transplantation for these patients ” states Göran Arvidson, CEO at Hansa Medical
AB.

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 September 14, 2015 at 14.30 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 Nasdaq First North in Stockholm with Remium Nordic AB as Certified
Adviser.