VANCOUVER, July 3 /PRNewswire/ - OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (NASDAQ: ISIS - News) announced today that the companies have amended their agreement and OncoGenex has elected to independently develop its lead cancer drug OGX-011. Under the amended agreement, OncoGenex is solely responsible for all future development activities, costs and partnering decisions related to OGX-011. Isis will no longer be responsible for funding 35% of development costs, will receive single digit royalties on future revenues of OGX-011, and will receive a portion of license fees and milestone payments received by OncoGenex from any future partner. There were no upfront payments associated with this amended agreement.
"This amendment allows us to increase our economic interest in OGX-011 as we advance the development of OGX-011 while also increasing our flexibility to further develop this product candidate," said Scott Cormack, President and CEO of OncoGenex. "In addition, we believe this new arrangement facilitates future partnering discussions since potential development and commercialization partners need only deal with one party."
"This amended agreement with OncoGenex is consistent with our strategy to remain focused on discovering and developing drugs and licensing prior to large Phase 3 trials. This has enabled us to continue to benefit from the successes of antisense drugs through a growing annuity of licensing fees, milestones and royalty payments with many focused partners," said B. Lynne Parshall, COO and CFO of Isis. "We believe that clinical results to date have established OGX-011 as one of many promising antisense drugs and OncoGenex is now ideally situated to lead the final stages of development of OGX-011 while allowing Isis to continue to benefit as future milestones and commercial revenues are realized. By working closely with OncoGenex during the development of OGX-011, we have confidence that OncoGenex will independently maximize the value of OGX-011."
"The contributions of Isis have been instrumental in the development of OGX-011 to date and we anticipate that our positive interactions will continue with this amended relationship," added Cormack.
Under the terms of the original co-development agreement, OncoGenex paid 65% of the development costs and would receive 65% of any economic benefit resulting from the development of OGX-011. Under the terms of the amended agreement, Isis' funding commitment for 35% of the OGX-011 program ends, and OncoGenex will be responsible for all future development costs of OGX-011. These expenses have already been factored into OncoGenex' previously announced disclosures regarding anticipated development costs. Isis will receive royalties for OGX-011 ranging from 5.5% to 7% of net sales. In addition, OncoGenex will pay Isis 30% of the upfront fees and milestone payments OncoGenex receives if OncoGenex licenses OGX-011 prior to initiation of registration trials, 25% if OGX-011 is licensed before 20% of patients have been enrolled in a registration trial, 20% if OGX-011 is licensed prior to marketing approval and 15% thereafter.
OncoGenex recently announced preliminary Phase 2 data of OGX-011 in patients with hormone refractory prostate cancer at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators found that, in this patient population, OGX-011 continues to show better than expected survival results when compared to published results. OGX-011, also referred to as custirsen sodium, is a second-generation antisense oligonucleotide designed to facilitate tumor cell death induced by chemotherapy by decreasing production of clusterin, a cell survival protein linked to treatment resistance. Preliminary analyses have shown that low-average levels of serum clusterin were predictive of the survival benefit. Additionally, patients treated with second-line chemotherapy plus OGX-011 experienced a reduction in pain that was durable as well as a decline in Prostate Specific Antigen (PSA). More information, including the ASCO data press release, is available on the company website at www.oncogenex.ca.
OncoGenex is a private biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. The company's three product candidates are designed to inhibit the production of specific proteins associated with treatment resistance and which are over-produced in response to a variety of cancer treatments. OGX-011 is completing evaluation in five Phase 2 clinical studies in prostate, lung, and breast cancers. OGX 427 has begun evaluation in Phase 1 clinical studies, while the third product candidate, OGX-225, has completed preclinical pharmacology studies. More information is available at www.oncogenex.ca.
This press release contains forward-looking statements, including statements concerning clinical trial results, future partnering activities and the economic benefits from developing OGX-011. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. For example, statements regarding the timing and anticipated results of clinical trials and development efforts, future partnering activities and economic benefits from developing OGX-011 are all forward-looking statements. The potential risks and uncertainties include, among others, that clinical results will not be maintained in final data analysis, that current or future clinical trials will not be successful or confirm the results of earlier studies, that OncoGenex may not realize the anticipated economic benefits from developing OGX-011 on its own, risks associated with obtaining funding from third parties or completing a financing necessary to support the costs and expenses of clinical studies, risks relating to the development, safety and efficacy of therapeutic drugs and potential applications for these products. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on the results of operations or financial condition of OncoGenex. OncoGenex undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof.
CONTACT: OncoGenex Contact: Scott Cormack, President & CEO, (604) 630-5400, firstname.lastname@example.org; OncoGenex Investor and Media Contact: Jason Spark, Porter Novelli Life Sciences, (619) 849-6005, email@example.com
Source: OncoGenex Technologies Inc.