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2016-12-12

Idogen: Positive decision for Idogen's orphan designation application in Europe

The European Medicines Agency's Committee for Orphan Medicinal
Products (COMP) has reached a positive decision regarding Idogen's
application for orphan drug designation in Europe. This means that
the COMP has made the assessment that the application meets all the
necessary criteria and they will therefore recommend that the
European Commission grants Idogen a formal orphan drug designation.

An orphan drug designation provides several important benefits for
Idogen. A product that is classified as an orphan drug receives
market exclusivity in the EU for ten years following marketing
authorization, regardless of the period of validity of any patents,
which is important for the value of any market position or license
agreement. Idogen also receives free consultation for scientific
advice, and fee reductions for regulatory applications for the
marketing authorization.

"Patients with hemophilia and antibodies against the factor VIII
treatment is a vulnerable patient population and there is a great
need for new treatments, which COMP's decision confirms. The news is
very encouraging and we are now awaiting the formal decision. Orphan
drug designation is an important milestone in our development and
represents a clear increase in value for this product." CEO Lars
Hedbys comments.

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

This is an English version of an original Swedish press release
communicated by Idogen AB. In case of interpretation issues or
possible differences between the different versions, the Swedish
version shall apply. This constitutes information that Idogen AB is
required to publish under the EU's Market Abuse Regulation. The
information was submitted for publication through the above contact
person on the 12th of December 2016.

Idogen develops tolerogenic vaccines which re-program the immune
system. The term "tolerogenic" refers to that the immune system will
tolerate the selected molecule after treatment. It represents a new
treatment method for autoimmune diseases, organ rejection after
transplantation and patients without treatment after developing
antibodies against standard treatment. The first indication for the
therapy will be patients with the bleeding disorder hemophilia A who
have developed an immunological reaction against their necessary
factor VIII replacement.

The treatment method comprises cells from the patient's blood being
reprogrammed to dendritic cells with the capacity to specifically
counteract the adverse immune reaction. The company's technology
platform has the potential to develop long-acting treatment of
anti-drug antibodies as well as autoimmune diseases that currently
cannot be cured. In addition, Idogen has the potential to change the
transplantation market by reducing the need for immunosuppressive
therapy after transplantation. Idogen was founded in 2008 based on a
fundamental immunological discovery at Lund University. For more
information, visit www.idogen.com

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http://news.cision.com/idogen/r/positive-decision-for-idogen-s-orphan-de...
http://mb.cision.com/Main/12368/2146095/602072.pdf

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