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BOTHELL, Wash. and VANCOUVER, British Columbia, April 27, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (OGXI) today announced that its wholly owned subsidiary, OncoGenex Technologies Inc., executed a termination agreement with Teva Pharmaceuticals Ltd. (TEVA) under which OncoGenex will regain rights to custirsen, an investigational compound currently in Phase 3 clinical development as a treatment for prostate and lung cancers. This transfer of rights occurs in connection with the termination of the 2009 collaboration agreement between OncoGenex and Teva.
"OncoGenex is excited to move forward with the clinical investigation of custirsen in patients with advanced cancers who desperately need new treatment options," said Scott Cormack, President and CEO of OncoGenex. "The finalization of this agreement gives OncoGenex control of custirsen's development, including the ability to move forward with plans to modify the ENSPIRIT trial design and statistical analysis plan to enable the trial to continue with fewer patients, increased confidence in success and shorter time to regulatory submission."
The agreement between the two parties to terminate the collaboration includes a $23.2 million payment from Teva.
This payment reflects a $27 million advance reimbursement amount less $0.8 million for expenses incurred by Teva in 2015 prior to the termination date as well as a $3 million holdback amount that may be used to settle additional expenses incurred by Teva related to the continued development of custirsen as well as certain indemnity claims. One half of the then remaining balance of the holdback amount will be released to OncoGenex in October 2015 with a further half of the then remaining amount paid in January 2016. Any final remaining amount will be released in April 2016.
In addition, OncoGenex will take over responsibility for all custirsen expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs that were previously managed by Teva.
The company recently reported that as of December 31, 2014, it had $47.1 million in cash, cash equivalents and short-term investments, excluding the advance reimbursement payment from Teva. OncoGenex expects that the $23.2 million payment from Teva and the Company's current resources should enable the completion of the AFFINITY trial through data readout in late 2015 or early 2016, allow for the continuation of the ENSPIRIT trial through the second interim futility analysis expected in mid-2015, and facilitate 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 trial
VANCOUVER, British Columbia, April 30, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (OGXI) announced today it has filed an amendment with the U.S. Food and Drug Administration, as well as initiated filing with regulatory agencies in other countries, to amend the statistical design and analysis plan of its pivotal, international Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of non-small cell lung cancer (NSCLC). OncoGenex recently regained the rights to the investigational compound from Teva Pharmaceuticals Ltd. and is currently in the process of assuming sponsorship for all clinical development related to custirsen.
The protocol amendment is designed to reduce the number of required patients enrolled in the trial and include an earlier, more rigorous second interim futility analysis. The protocol will now also include additional analyses, specifically an evaluation of overall survival (OS) by patient histology, as well as the effect of custirsen's efficacy among patients with poor prognostic risk factors. These changes do not affect the criteria for enrollment or conduct of the study, which continues to accrue patients. Enrollment is expected to be completed in the second half of 2016
von TEVA ändert ja nichts an den von mir genannten "guten Fakten".
So ein Partner steigt auch schon mal aus, auch wenn es eigentlich nichts negatives gibt (siehe ONO bei Paion oder kürzlich auch Celgene bei MorphoSys).
Denke der Ausstieg von TEVA dürfte zwischenzeitlich eingepreisst sein.
Im Übrigen bin ich derzeit noch mit einem überschaubaren Betrag drin (ob`s mehr wird, wird die Zeit zeigen. Aber ich habe auf alle Fälle den Fuß in der Tür, zu einem meiner Meinung nach günstigen Kurs).
Oncogenex (OGXI) und Threashold (THLD) sind mit ähnlicher Pipeline beide mit ihren Medis gescheitert und stark abgeschmiert,THLD hat zwar grade 100% hingelegt,aber ich sehe keinen Grund warum man diese beiden aktien kaufen sollte ?
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