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2016-12-15

Hansa Medical: Hansa Medical's application for Orphan Drug Designation for IdeS in the EU receives positive opinion

LUND, Sweden, December 15, 2016, Hansa Medical AB (publ: HMED), a
biopharmaceutical company focusing on novel immunomodulatory enzymes,
announces that the Committee for Orphan Medicinal Products (COMP) at
the European Medicines Agency (EMA) has issued a positive opinion on
Hansa Medical's application for Orphan Drug Designation of
recombinant IdeS for the prevention of graft rejection following
solid organ transplantation. In September 2015, IdeS was granted
Orphan Drug Designation for the prevention of antibody mediated organ
rejection in solid organ transplant patients by the U.S. Food and
Drug Administration (FDA).

Commenting on today's announcement, Göran Arvidson, CEO of Hansa
Medical, said:

"The positive opinion from the Committee for Orphan Medicinal Products
on our Orphan Drug Designation application for IdeS is another
important regulatory milestone, following the grant of Orphan Drug
Designation from the FDA in 2015. Transplantation is a lifesaving
procedure which can significantly improve the quality of life of
these very sick patients. Sadly many patients are unable to receive
the transplant they need because they are highly sensitized with
significant levels of antibodies which can cause organ rejection. We
believe IdeS has the potential to revolutionize the transplant
process and to become the first therapy to enable these patients to
be transplanted. The current preliminary clinical data generated with
IdeS in kidney transplantation have been highly encouraging and we
look forward to progressing it through the pivotal trial towards
registration."

Based on positive opinion from the Committee for Orphan Medicinal
Products (COMP), the European Commission grant Orphan Drug
Designation to drugs intended for the treatment of life threatening
or chronically debilitating rare diseases where no therapeutic
options are either authorised or where the drugs will be of
significant benefit to those affected by the condition. Rare diseases
are those defined as having a prevalence of no more than five in
10,000 persons in Europe. The designation provides development and
commercial incentives, including 10 years of market exclusivity,
protocol assistance on the development of the drug, including
clinical studies, and certain exemptions from or reductions in
regulatory fees.

This information is information that Hansa Medical AB (publ) is
obliged to make public pursuant to the Financial Instruments Trading
Act. The information was submitted for publication at 08:30am CET on
December 15, 2016.

For further information, please contact:
Hansa Medical AB (Publ)
Emanuel Björne, Vice President Business Development and Investor
Relations

Mobile: +46 70 717 5477
E-mail: emanuel.bjorne@hansamedical.com
Göran Arvidson, CEO
Mobile: +46 70 633 3042
E-mail: goran.arvidson@hansamedical.com

www.hansamedical.com

Cord Communications, Stockholm
Mikael Widell
Mobile: +46 70 311 9960

Lars Wahlström
Mobile: +46 73 434 0771

FTI Consulting, London
Julia Phillips / Stephanie Cuthbert / Hanna Skeppner: +44 203 727
1000

About IdeS
IdeS, IgG degrading enzyme of Streptococcus pyogenes, is an enzyme
that depletes IgG antibodies fast and effectively. Hansa Medical is
developing IdeS as a proprietary treatment to enable kidney
transplantation in sensitized patients, previously unable to undergo
transplantation surgery due to the presence of anti-HLA IgG
antibodies. Preliminary efficacy data reported from three phase 2
studies have demonstrated that IdeS rapidly and significantly reduced
anti-HLA antibodies, enabling transplantation. IdeS is currently
being evaluated in a multi-center study in the U.S. in highly
sensitized patients that do not respond to available desensitization
methods. Results from this study are expected in 2018. 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 sensitized patients
Approximately 30 percent of the patients on the waiting lists for
kidney, liver, heart, lung and pancreas transplants, equivalent to
more than 30,000 patients in Europe, are sensitized to HLAs. HLA
sensitization is a risk factor in transplantation meaning that a
significant number of sensitized patients are rarely considered for
transplantation due to the increased risk of antibody mediated organ
rejection.

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focusing on novel
immunomodulatory enzymes. The lead project IdeS is a proprietary
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.

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http://news.cision.com/hansa-medical/r/hansa-medical-s-application-for-o...
http://mb.cision.com/Main/1219/2150646/604190.pdf

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