Diamyd regains control of diabetes therapy
Diamyd Medical AB announces it has regained control of the diabetes
therapy Diamyd® following Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(OMJPI) election to terminate the agreement the two companies signed in
June 2010 to develop and commercialize Diamyd®.
In June 2010, Diamyd Medical AB and Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, signed an
agreement to develop and commercialize the GAD65-based therapy Diamyd®,
for the treatment and prevention of type 1 diabetes and associated
conditions. Under the agreement Diamyd Medical received a non-refundable
upfront payment of USD 45 million and the parties began sharing the
costs for the development program equally. Following termination of the
agreement by OMJPI all rights regarding Diamyd® and the active substance
GAD65 are returned to Diamyd Medical.
“We have thoroughly enjoyed working with Ortho-McNeil-Janssen
Pharmaceuticals, Inc. and we hope to have more opportunities for
cooperation in the future,” says Peter Zerhouni, Acting President and
CEO of Diamyd Medical. “With all the rights to returned to us we are
free to decide on how to extract the most value from GAD65 going
forward.”
The termination of the agreement follows the evaluation of the results
of a European Phase III study with Diamyd® reported on May 9. The study
did not meet the primary efficacy endpoint of preserving beta cell
function at 15 months in patients newly diagnosed with type 1 diabetes,
although a small positive effect was seen. Diamyd® was well tolerated as
demonstrated by a similar number of adverse events in the Diamyd®
treated groups as well as in the placebo treated group. Detailed results
will be presented at the American Diabetes Association's 71st Scientific
Sessions in San Diego, CA, USA, June 24-28, 2011.
An ongoing parallel US Phase III study, DiaPrevent, was fully enrolled
in December 2010, and results are expected in the summer of 2012. In
addition, the research consortium Type 1 Diabetes TrialNet is conducting
a Phase II trial with Diamyd® in the US and Canada with similar design.
Another externally funded and researcher-initiated Phase II study with
Diamyd® is in progress aiming to prevent type 1 diabetes from developing
in high risk subjects.
Apart from the diabetes therapy Diamyd® the Company's portfolio of
development projects consist of several drug candidates in clinical and
preclinical phases that use the Company's patented NTDDS platform (Nerve
Targeting Drug Delivery System) for the administration of drugs directly
to the nervous system.
The rights to the application of the GAD65 gene in the treatment of
Parkinson's disease have been out-licensed on a non-exclusive basis to
the American company Neurologix, Inc., which recently presented Phase II
data on their GAD-based drug candidate NLX-P101 confirming sustained,
positive long-term efficacy in Parkinson patients.
Besides the portfolio of patented technological platforms and
development projects, Diamyd Medical has holdings in Protein Sciences
Corporation (US) and Mercodia AB (Sweden).
The Company's liquid assets amounted to SEK 474 million as of February
28, 2011.
For more information, please contact:
Peter Zerhouni, Acting President and CEO Diamyd Medical AB (publ.)
Phone: 46 8 661 0026
For press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
press@diamyd.com (press@diamyd.com)
Phone: 46 8 661 0026
