English
Published: 2018-09-17 08:00:00 CEST
Hansa Biopharma AB
Other information disclosed according to the rules of the Exchange
Hansa Medical Announces Appointment of Vincenza Nigro as Vice President, Global Medical Affairs
Lund, Sweden, September 17, 2018 -- Hansa Medical AB (NASDAQ Stockholm: HMED),
a
biopharmaceutical company focused on immunomodulatory enzymes for
organ
transplantation and acute autoimmune conditions, today announced the
appointment
of Vincenza Nigro as Vice President, Global Medical Affairs.
Ms.
Nigro brings more than two decades of international, life sciences
industry
expertise in medical affairs, clinical development and commercial
leadership
roles, including deep experience in transplantation and orphan
diseases. She
will report to Søren Tulstrup, President & CEO of Hansa Medical
and will be
based in the US.  Ms. Nigro will assume overall responsibility for
Hansa
Medical’s global medical affairs strategy for its lead candidate
imlifidase
(INN), also known as IdeS, including pre-launch medical affairs
activities for
imlifidase in kidney transplantation. She will also be
responsible for expanding
and leading Hansa Medical’s global medical affairs
team, with her primary focus
on the US and Europe.

Imlifidase is an enzyme
with a novel and proprietary mechanism to rapidly and
specifically cleave
immunoglobulin G (IgG), enabling kidney transplantation in
sensitized patients.
Follow-up data from two Phase 2 studies of imlifidase in
kidney transplantation
are expected later this month; these results have the
potential to serve as the
basis of a Biologics License Application (BLA)
submission to the US Food and
Drug Administration.

“We are delighted to welcome Vincenza to Hansa at this
exciting time as we await
follow-up data from our Phase 2 trials for
iImlifidase in kidney
transplantation. With her extensive experience building
and leading high
-performance medical affairs teams and life cycle management
of innovative
transplant related and immunology products, she will be a strong
and valuable
addition to our team as we transform Hansa Medical into a
full-fledged, global
commercial-stage biotech company,” said Søren Tulstrup,
President & CEO of Hansa
Medical.

Most recently, Ms. Nigro built and led the
global medical affairs function at
Veloxis, a specialty pharmaceutical company
focused on transplantation.
Previously, she spent over a decade at Hoffmann-La
Roche in the US in drug
discovery, clinical development and commercial roles
within immunology and
transplantation. She has also held a commercial
leadership role at US specialty
pharma company Enzon Pharmaceuticals, which was
focused on oncology. Ms. Nigro
holds a Bachelor of Science degree in Biology
from Fairleigh Dickinson
University and an MBA degree from Massachusetts
Institute of Technology (MIT).

This is information that Hansa Medical AB is
obliged to make public pursuant to
the EU Market Abuse Regulation. The
information was submitted for publication,
through the agency of the contact
person set out below at 08:00am CET on
September 17, 2018.

About
imlifidase
Imlididase (IdeS) is an enzyme that depletes Immunoglobulin G (IgG)
antibodies
fast and effectively. Hansa Medical is developing imlifidase as a
proprietary
treatment to enable kidney transplantation in sensitized patients,
previously
unable to undergo transplant surgery due to the presence of
anti-human leukocyte
antigen (HLA) IgG antibodies. Efficacy data reported from
three Phase 2 studies
have demonstrated that imlifidase rapidly and
significantly reduced anti-HLA
antibodies, enabling transplantation. In
addition to transplantation, imlifidase
is being evaluated in a clinical Phase
2 study in the rare autoimmune disease
anti-GBM antibody disease and imlifidase
has potential applications in a variety
of additional autoimmune diseases.
Imlifidase is protected by several patents
and results of studies with
imlifidase have been published in a number of peer
reviewed scientific
journals.

About sensitized patients
Many patients on the waiting list for
organ transplantation are ‘sensitized,’
meaning they carry antibodies to HLA.
When these antibodies are targeted towards
the HLA of a potential donor, they
are known as donor specific antibodies (DSA)
and can significantly compromise a
transplanted organ. Patients with high levels
of antibodies are highly
sensitized and have a very low likelihood of finding a
donor towards which they
will not have DSA. Therefore, they may not be able to
receive a transplantation
at all and remain in a severe and debilitating disease
state.

About Hansa
Medical
Hansa Medical is a biopharmaceutical company developing novel
immunomodulatory
enzymes for organ transplantation and acute autoimmune
diseases. The lead
product, imlifidase (IdeS), is a proprietary
antibody-degrading enzyme currently
in late-stage clinical development for
kidney transplant patients, with
significant potential for further development
in other solid organ transplants
and in acute autoimmune indications. The
company also has a strong pipeline of
preclinical projects that may provide a
second wave of potential drugs. Under
the project name NiceR, novel
immunoglobulin-cleaving enzymes are developed for
repeat dosing with the
objective of applying the Hansa Medical technology in
relapsing autoimmune
diseases and oncology. Hansa Medical is based in Lund,
Sweden, and its shares
are listed on Nasdaq Stockholm (ticker: HMED).

For further information, please
contact:
Hansa Medical AB (Publ)

Emanuel Björne, Vice President Business
Development and Investor Relations
Mobile:
+46707175477
E-mail: emanuel.bjorne@hansamedical.com
www.hansamedical.com

 


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