The Hansa Medical candidate drug IdeS has enabled successful kidney transplantation

A successful kidney transplantation of an HLA sensitized patient has been
accomplished following desensitization with the candidate drug IdeS at Uppsala
University Hospital. The patient is enrolled in the ongoing Phase II study
sponsored by Hansa Medical with the primary objective to study IdeS’ capacity to
reduce levels of anti-HLA antibodies in sensitized patients.
HLA sensitized patients rarely become transplanted due to the immediate risk of
transplant rejection caused by donor specific anti-HLA antibodies. However,
following treatment with IdeS the now transplanted patient became eligible for
deceased donor transplantation after treatment with IdeS. The cross match test,
determining if the patient was compatible with the deceased donor, showed that
the donor specific antibodies had been completely inactivated by the IdeS
-treatment making the cross match negative. The patient was then successfully
transplanted and the transplanted kidney is now perfectly functional.

“We have demonstrated, for the first time, that IdeS can enable transplantation
for patients burdened by anti-HLA antibodies as the primary obstacle to
transplantation. I am very happy that we by treatment with IdeS, have managed to
help this patient to become transplanted,” comments Emanuel Björne, CEO Hansa
Medical AB (publ).

Thousands of sensitized patients around the world live in a hopeless wait,
hindered from transplantation due to high levels of anti-HLA antibodies. These
patients face long-term dialysis, associated with significantly shortened life
expectancy and reduced quality of life. The goal of Hansa Medical is that all
these patients shall be transplanted through treatment with IdeS.

“We have purposefully brought our unique IdeS-concept from discovery, through
phases of research and development into effective and safe treatment of a
patient. This brings hope to patients in need and is a major success for my
dedicated colleagues here at Hansa Medical and at Uppsala University Hospital as
well as for our long term committed owners whose investments made this
possible,” concludes Emanuel Björne, CEO Hansa Medical AB (publ).

More on IdeS
The candidate drug IdeS is developed as a fast, effective and safe method to
deactivate anti-HLA antibodies in sensitized patients prior to kidney
transplantation. During 2013, a successful Phase I-study on 29 healthy subjects
was performed, demonstrating IdeS as efficacious and well tolerated with a
favourable safety profile. The purpose of the ongoing Phase II-study is to
explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients
awaiting kidney transplantation. The objective is to generate significant
clinical data in order to enable a pivotal phase III trial. In total,
approximately 20 patients will be enrolled in two separate phase II studies
planned to last until the second quarter of 2015.
For further information, please contact:
Hansa Medical AB
Emanuel Björne, CEO Hansa Medical AB (publ)
Mobile: 46 707 17 54 77
E-mail: emanuel.bjorne@hansamedical.com
www.hansamedical.com
Hansa Medical pursues clinical development and commercialization of innovative
pharmaceuticals and diagnostic methods for the benefit of patients with serious
and rare inflammatory diseases. The portfolio includes a marketed diagnostic
product, a drug candidate in clinical development, and a preclinical research
project. Major shareholders are Bo Håkansson via Farstorps Gård AB, and Nexttobe
AB. Hansa Medical is listed on NASDAQ OMX First North (HMED) and Remium Nordic
AB is the company’s Certified Adviser. The information in this press release is
such information that Hansa Medical AB (publ) is obliged to disclose under the
Securities Market Act and/or the Financial Instruments Trading Act. The
information was made public on August 18, 2014 at 08:00 CET.