OncoGenex Pharmaceuticals, Inc. OGXI today announced that it has
executed an initial agreement with Teva Pharmaceutical Industries Ltd. TEVA to regain rights to custirsen, an investigational compound currently
being evaluated in Phase 3 clinical development as a treatment for prostate
and lung cancers. This transfer of rights would occur in connection with the
termination of the collaboration agreement between OncoGenex and Teva executed
in 2009.
The initial agreement reached by OncoGenex and Teva provides that, following
execution of the final agreement to terminate the collaboration between the
parties, OncoGenex will receive a $27 million payment from Teva, subject to
certain adjustments. In addition, OncoGenex will take over responsibility for
all custirsen related expenses, including those related to the ENSPIRIT trial,
as well as manufacturing and regulatory activities for custirsen programs,
which are currently being managed by Teva. OncoGenex expects that the $27
million payment from Teva will allow for the completion and final results from
the AFFINITY trial, as well as continuation of the ENSPIRIT trial through the
second interim futility analysis expected in the first half of 2015.
"Teva's strategic focus has shifted away from oncology research and
development. However, OncoGenex remains committed to the continued
investigation of custirsen, particularly in patients who have advancing
disease despite previous treatments," said Scott Cormack, President and CEO of
OncoGenex. "This agreement provides OncoGenex with greater control of
custirsen's development, including the modification of the ENSPIRIT
statistical analysis plan to involve a more rigorous second interim futility
analysis to be completed in the second quarter of 2015 that, if passed, would
enable the trial to continue with a smaller enrollment requirement, increased
confidence in success and shorter time to regulatory submission."
The Company expects that the $27 million payment from Teva and the Company's
current resources should enable the completion of the AFFINITY trial through
data readout in late 2015/early 2016, allow for the continuation of the
ENSPIRIT trial through the second interim futility analysis that is expected
in the first half of 2015 and the achievement of key apatorsen clinical
milestones, such as the completion of patient enrollment in the Borealis-2™
trial and final data from the Spruce™ and Rainier™ clinical trials.
The Company anticipates a final agreement will be executed in January 2015.
Additional terms of the initial agreement with Teva can be found in the
Company's Form 8-K filed today and available at http://ir.oncogenex.com.
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