Diamyd Medical licenses candidate drug for diabetes and gluten intolerance


Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) announces today
that it has entered into an exclusive license agreement for using the gluten
protein gliadin for the treatment and prevention of type 1 diabetes. Diamyd
Medical aims at evaluating combination regimens of gliadin with compounds and
antigens, such as for example GABA and GAD, for shutting off the inflammatory
component in type 1 diabetes, gluten intolerance and other inflammatory
diseases, for which preliminary patent applications have been filed. The world
market for a successful new drug for treatment and prevention of autoimmune
diabetes and gluten intolerance (celiac disease) is considered to be several
billion US dollars.
The new exclusive license covers a drug candidate based on the environmental
antigen gliadin that has been shown to play a role in the onset of type 1
diabetes in animal models. By developing tolerance towards gliadin, the insulin
producing beta cell’s functionality and survival rate may be improved. Pre
-clinical proof of concept (Funda, PLOS ONE 2014, Prevention and Early Cure of
Type 1 Diabetes by Intranasal Administration of Gliadin in NOD Mice) for the
drug candidate has been obtained where nasal administration of gliadin
significantly reduced incidence of the disease and delayed onset.

The license deal was made directly between Diamyd Medical and the inventors.
Economic terms are mainly based on royalties and not expected to significantly
affect the Company’s financial position. Diamyd Medical has filed its own
preliminary patent applications seeking to protect methods and formulations for
using gliadin in combination with other compounds for treatment and prevention
of inflammatory and autoimmune disorders beyond diabetes.

The onset of type 1 diabetes is, in addition to autoimmune attack, often
considered to be in association with an inflammation in the pancreas. The exact
cause of the inflammation is currently unknown, but environmental factors are
assumed to be involved.

“This represents the first successful use of this type of an exogenous
environmental antigen in type 1 diabetes disease treatment and prevention,” says
Professor Karsten Buschard, MD, Charlottenlund, Denmark, one of the inventors of
the licensed technology. “Gluten free diet is another approach being
investigated for preventing type 1 diabetes, but it may not be adequate for
treatment of disease once presented. Gluten free diet is also very cumbersome to
adhere to. Inducing tolerance to the antigen may be a better way forward.”

“Gliadin is a major antigen in celiac disease and gut disorders, and celiac
disease and type 1 diabetes often go together,” says Anders Essen-Möller,
President and CEO of Diamyd Medical. “The Celiac Disease Foundation estimates
the prevalence of celiac disease in patients with type 1 diabetes to be
approximately eight percent, but only one percent in the general population. We
believe that gliadin treatment has a place in combatting these and other
diseases and that gliadin and our other proprietary technologies under
development, such as GABA and the diabetes vaccine Diamyd®, may work
synergistically in several aspects.”

About Diamyd Medical
Diamyd Medical is dedicated to working toward a cure for type 1 diabetes and
LADA. The Company’s projects include development of combination regimens with
the GAD-based diabetes vaccine Diamyd® for arresting the destruction of insulin
-producing beta cells. Diamyd® is considered to be the world’s furthest
developed Antigen Based Therapy (ABT) for treating the disease. At this time six
clinical studies are ongoing. The Company exclusively licenses UCLA-rights to
GAD65, the active ingredient in the vaccine, for which the last patent expires
in 2032. Additionally, the Company exclusively licenses UCLA patents for using
GABA for the treatment of diabetes and other inflammation-related conditions.

Diamyd Medical is one of the major shareholders in the stem cell company
Cellaviva AB, which offers private family saving of stem cells in umbilical cord
blood. Stem cells can be expected to be used in Personalized Regenerative
Medicine (PRM), for example, for restoration of beta cell mass in diabetes
patients where the autoimmune component of the disease has been arrested by ABT.

Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@diamyd.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.

Attachments

08311033.pdf