DIAMYD UPDATES FDA IND APPROVAL STATUS FOR PHASE III DIAMYD® DIABETES STUDY IN THE US


DIAMYD UPDATES FDA IND APPROVAL STATUS FOR PHASE III DIAMYD® DIABETES STUDY IN
THE US

Press Release, Stockholm, Sweden, February 12, 2008 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)

Diamyd Medical announced today that it has received one FDA question relating to
the US Phase III IND application for Diamyd® in treatment of type 1 diabetes.
The question has been answered with additional documentation and the FDA now has
30 days to respond.

“Our Phase III IND file contains extensive documentation and a rigorous review
by the FDA identified only one manufacturing question that required submission
of additional data,” stated Elisabeth Lindner, CEO of Diamyd Medical. “We have
worked diligently with our Drug Product manufacturing contractor last week to
compile the data and the matter has now been fully addressed. Considering the
nature of a Phase III application requiring very extensive documentation, we are
very satisfied with this outcome. Importantly, to date no immediate
modifications for our clinical trial design have been requested by the FDA and
we anticipate starting the Phase III clinical program according to plan.”

The US Phase III clinical trial is a double-blind study including approximately
300 new onset type 1 diabetes patients. A similar Phase III trial is planned for
Europe, which has been initiated with a clinical trial application in Sweden.

In parallel with the Diamyd® Phase III program, NIH/NIDDK with TrialNet are
planning a study with 126 new onset type 1 diabetes patients to further evaluate
efficacy and mechanism of action of Diamyd®.

For further information, please contact:
Stockholm office
Elisabeth Lindner
CEO and President 
+46 8 661 0026
elisabeth.lindner@diamyd.com

Stockholm office
Anders Essen-Möller
Chairman
+46 8 661 0026
anders.essen-moller@diamyd.com

Pittsburgh office
Michael Christini
President
+1 412 770 1310
michael.christini@diamyd.com

Diamyd Medical AB (publ). Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Tel: +46
8 661 00 26, fax: +46 8 661 63 68 or E-mail: info@diamyd.com. VATno:
SE556530-142001.

About Diamyd Medical
Diamyd Medical is a biopharmaceutical company developing treatments for diabetes
and its complications. The company's furthest developed project is the GAD-based
drug Diamyd® for autoimmune diabetes for which Phase III studies are planned.
Diamyd® has demonstrated significant and positive results in Phase II clinical
trials in Sweden.

GAD65, a major autoantigen in autoimmune diabetes, is the active substance in
Diamyd. GAD65 is also an enzyme that converts the excitatory neurotransmitter
glutamate to the inhibitory transmitter GABA. In this context, GAD may have an
important role not only in diabetes but also in several central nervous
system-related diseases. Diamyd Medical has an exclusive worldwide license from
the University of California at Los Angeles regarding the therapeutic use of the
GAD65 gene.

Diamyd Medical has sublicensed its UCLA GAD Composition of Matter license to
Neurologix, Inc. in Fort Lee, New Jersey for treatment of Parkinson's disease.

Other projects comprise drug development within therapeutic gene transfer using
the exclusively licensed and patent protected Nerve Targeting Drug Delivery
System (NTDDS). The company's lead NTDDS projects include enkephalin and GAD for
chronic pain, e.g., diabetes pain or cancer pain. 

Diamyd Medical has offices in Stockholm, Sweden and Pittsburgh, PA. The Diamyd
Medical share is quoted on the Stockholm Nordic Exchange in Sweden (NOMX ticker:
DIAM B) and on the OTCQX-list in the United States (ticker: DMYDY) administered
by the Pink Sheets and the Bank of New York (PAL). Further information is
available at www.diamyd.com.

Disclaimer: This document contains certain "statements" relating to present
understandings, future events and future performance, including statements
relating to the progress, timing and completion of our research, development and
clinical trials; our ability to market, commercialize and achieve market
acceptance for product candidates; and our current and future strategic partner
relationships. These statements can be affected by inaccurate assumptions or by
known or unknown risks and uncertainties. Diamyd Medical undertakes no
obligation to publicly update such statements, whether because of new
information, future events or otherwise, nor does Diamyd Medical give any
guarantees that the statements, given or implied, are correct. This document is
a translation from the Swedish original. No guarantees are made that the
translation is free from errors.

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