“Besides our ongoing partnership discussions, we will primarily focus on completing the Phase III studies and prepare for market launch of Diamyd®.”
In her comments in today's quarterly report, Elisabeth Lindner, President and CEO of Diamyd Medical (STO:DIAMB), describes the progress in the decisive Phase III studies with the Company's lead drug candidate Diamyd®, and comments on the Company's strategies and efforts to build a Nordic specialty pharmaceutical company.
"We have exciting times ahead of us with only one year to go before we have the results from our European Phase III study. Our hard work starts to pay off," says Elisabeth Lindner, President and CEO of Diamyd Medical. "Besides our ongoing partnership discussions, we will primarily focus on completing the Phase III studies and prepare for market launch of Diamyd®."
During the report period Diamyd Medical could announce that the US FDA approved the experimental use of Diamyd® in children as young as 3 years of age in the TrialNet GAD study. TrialNet has in April announced that the study is fully enrolled. The study includes 126 new onset type 1 diabetes patients.
The Company has further announced during the period, that the ongoing partnership negotiations regarding out-licensing of market rights for the Diamyd® portfolio are at an advanced stage. At the Annual Shareholder's Meeting in December, a 2:1 division of shares (a split) was resolved. The split was executed in January.
After the end of the period, the US FDA has granted Diamyd® Orphan Drug Designation in the USA, which among other things qualifies Diamyd® for seven years of market exclusivity, tax credits for clinical research and a waiver for certain FDA fees. Further, Diamyd has announced that the Company's US Phase III study, DiaPrevent, has enrolled one hundred study participants at 33 diabetes centers and that more sites will be added. Additionally Diamyd has received 35 MSEK through a direct placement.
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