OncoGenex Pharmaceuticals, Inc. (OGXI) has executed an initial agreement to retrieve all rights pertaining to the late-stage oncology candidate, custirsen, from Teva Pharmaceutical Industries Ltd. (TEVA).
With the transfer of rights, both companies have decided to terminate their collaboration agreement, signed in Dec 2009, for the development and commercialization of custirsen and other related compounds.
According to OncoGenex, Teva has shifted its strategic focus away from oncology-related research and development. Hence, with continued focus on the development of custirsen, OncoGenex decided to regain all rights to the candidate.
Custirsen is currently being evaluated in three phase III studies (SYNERGY, AFFINITY and ENSPIRIT) for the treatment of prostate and lung cancer. It has fast track designation in the U.S. for second-line treatment of metastatic castrate resistant prostate cancer (CRPC) in combination with Jevtana and prednisone, and advanced non small cell lung cancer (NSCLC) in combination with Taxotere in patients with disease progression following first-line treatment.
Terms to End the Deal
OncoGenex will receive a $27 million payment from Teva upon the execution of the final agreement to terminate their collaboration. Going forward, OncoGenex will be solely responsible for all expenses related to the development, manufacturing and regulatory activities involving the candidate.
OncoGenex believes that the addition of $27 million payment to company’s resources will facilitate a number of ongoing trials. Firstly, it will fund the completion of the AFFINITY study through a data readout scheduled in late 2015 or early 2016. Secondly, it should help advance the ENSPIRIT study (including modification of the ENSPIRIT statistical analysis plan) through a second interim futility analysis, which is expected in the first half of 2015. If the study passes the second interim futility analysis successfully, it can continue with a smaller patient-enrollment requirement, leading to shorter time to regulatory submission.
We note that the ENSPIRIT study has already completed the first interim futility analysis and is currently enrolling patients suffering from NSCLC. Meanwhile, the AFFINITY study is fully enrolled.
Additionally, these resources should help OncoGenex to complete patient enrollment in the Borealis-2 study on apatorsen as well as obtain final data from the Spruce and Rainier studies evaluating apatorsen.
OncoGenex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Lannett Company, Inc. (LCI) and Apricus Biosciences, Inc. (APRI). Both carry a Zacks Rank #1 (Strong Buy).
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