Diamyd's Phase III studies continue to follow plan
In her comments in today's quarterly report, Elisabeth Lindner, President and
CEO of Diamyd Medical, 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.
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026
