Diamyd on the threshold of a new era
In her comments in today's quarterly report, Elisabeth Lindner,
President and CEO of Diamyd Medical, notes that a new chapter has begun
in the Company's history with last week's agreement with
Ortho-McNeil-Janssen Pharmaceuticals, Inc., to develop and commercialize
the Diamyd® diabetes therapy.
"We will realize the plan to bring Diamyd® to the market in the Nordic
countries ourselves and have negotiated exclusivity for this region,"
says Elisabeth Lindner, President and CEO of Diamyd Medical. "The Nordic
market is a prestige market for type 1 diabetes in that the Nordic
countries have the highest incidence of the disease in the world."
During the report period Diamyd Medical could announce that 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 SEK 35 million through a direct placement.
After the end of the period, Diamyd signed an agreement with
Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson
company, to develop and commercialize the Diamyd® diabetes therapy.
OMJPI will make an upfront payment of USD 45 million, and under the
terms of the agreement, Diamyd has the potential to receive additional
development and sales milestone payments of up to USD 580 million, as
well as tiered royalties on future sales.
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
