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®.