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2016-12-22

Diamyd Medical AB: Diamyd Medical prepares GMP-production of GABA

Diamyd Medical announced today that a first amount of GABA has been
produced and that the manufacturing process is to be scaled up for
GMP production. The Company also highlights that two recently
published scientific articles support GABA's relevance in the
treatment of diabetes.

Diamyd Medical has, as previously reported, expanded its operations to
include type 2 diabetes and rheumatoid arthritis, where a significant
part of the development plan is manufacturing of a proprietary GABA
drug product. Diamyd Medical has during the autumn visited its
selected manufacturer. GABA synthesis and the analysis process has
proceeded according to plan and a first amount of GABA has been
produced. The process will now be scaled up for future GMP production
which will result in a drug product ready to be used for clinical
trials in humans.

Diamyd Medical also highlights that two articles have been published
in the scientific journal Cell, both of which point to the relevance
of GABA and the treatment of diabetes (Othman et al., Li et al.). The
scientific research has shown through various in vivo studies that
administration of GABA and promotion of GABA signaling stimulates
beta cell growth by transforming alpha cells to beta-like cells that
can functionally replace the endogenous beta cells. Preclinical
trials conducted by Diamyd Medical with GABA are in progress in type
1 and type 2 diabetes as well as in rheumatoid arthritis, and further
studies are planned. The aim of these trials is to understand in more
detail how the dose is connected to the various effects of GABA
within the various disease models, and to make some comparisons with
existing drugs.

"I'm glad to report that the GABA production proceeds smoothly and
that we have taken the next step towards our own GABA-drug product,"
says Ulf Hannelius, President and CEO of Diamyd Medical. "The support
the articles in Cell, one of the most prestigious scientific
journals, provides for GABA's role in diabetes is also very positive.
This shows the potential that could be found in a GABA-treatment with
the aim to restore insulin production in individuals suffering from
diabetes."

The articles "Long-Term GABA Administration Induces Alpha
Cell-Mediated Beta-like Cell Neogenesis" and " Artemisinins Target
GABAA Receptor Signaling and Impair ? Cell Identity" are published on
Cells' website (www.cell.com) and are available through the following
links:

http://dx.doi.org/10.1016/j.cell.2016.11.002

http://dx.doi.org/10.1016/j.cell.2016.11.010

About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other
serious inflammatory diseases through pharmaceutical development and
investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, an
antigen-specific immunotherapy based on the exclusively licensed
GAD-molecule. Six clinical studies are ongoing with Diamyd®. GABA
constitutes alongside with the diabetes vaccine a key asset in Diamyd
Medical and the Company uses its GABA in-licensed technology to
develop a proprietary GABA drug product. Diamyd Medical is one of the
major shareholders in the stem cell company NextCell Pharma AB
(former Cellaviva AB). Diamyd Medical also has holdings in the
medtech company Companion Medical, Inc., San Diego, USA and in the
gene therapy company Periphagen, Inc., Pittsburgh, USA.

Diamyd Medical's B-share is traded on Nasdaq Stockholm First North
under the ticker DMYD B. FNCA Sweden AB is the Company's Certified
Adviser.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@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
This information is information that Diamyd 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 above, at 08.30 CET on December 22, 2016

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http://news.cision.com/diamyd-medical-ab/r/diamyd-medical-prepares-gmp-p...
http://mb.cision.com/Main/6746/2155416/607314.pdf

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