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"The progress our partners are making with antisense drugs discoveredusing Isis' antisense technology demonstrates the value of our technology tocreate drugs that are first-in-class and may provide new treatment options ina broad range of diseases, including cancer," said Stanley Crooke, Chairmanand Chief Executive Officer of Isis. "We are encouraged by the latest resultsfrom OGX-011 and look forward to OncoGenex announcing the full results of thestudy next year."
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According to OncoGenex' announcement, the Phase 2 randomized study in 82patients with metastatic or locally recurring prostate cancer refractory tohormone therapy showed a median survival of 27.5 months for the patients inthe OGX-011 arm and 16.9 months for patients in the control arm. Resultscurrently indicate that patients in the OGX-011 arm have a death rateapproximately 40% lower than patients in the control arm. The current resultswere based on study data with a median follow-up of approximately 30 monthsfor both arms. OncoGenex indicates that additional survival updates will beneeded before mature median survival for the OGX-011 arm can be reported.Based on the current results, OncoGenex has calculated that the final mediansurvival for patients in the OGX-011 arm cannot be lower than 22.7 months.The trial was conducted and data were analyzed by the National CancerInstitute of Canada, Clinical Trials Group and was supported by a grant fromthe NCI-Canada with funding from the Canadian Cancer Society. For furtherdetails on the study, please see OncoGenex' release that was issued today,December 3, 2008.
ABOUT OGX-011
OGX-011 is designed to inhibit the production of clusterin, a protein thatis associated with treatment resistance and is currently being evaluated inPhase 2 clinical studies in prostate, lung and breast cancer. It has receivedFast Track designation from the U.S. Food & Drug Administration (FDA) incombination with docetaxel for progressive metastatic prostate cancer.Recently, the FDA confirmed the appropriateness of durable pain palliation asa primary endpoint for product marketing approval for OGX-011 as a treatmentfor hormone refractory prostate cancer. Earlier this year at ASCO, OncoGenexreported OGX-011 Phase 2 data showing better than expected survival results incombination with chemotherapy, reduction in levels of clusterin, durablereductions in pain, and a decline in PSA, a protein that is often elevated inpatients with prostate cancer.
OGX-011 was jointly discovered by Isis and OncoGenex and until July 2,2008 was co-developed by Isis and OncoGenex. OncoGenex is now responsible forall development costs and activities of OGX-011. Isis will receive royaltiesfor OGX-011 ranging from 5.5% to 7% of net sales. In addition, OncoGenex willpay Isis 30% of the upfront fees and milestone payments OncoGenex receives ifOncoGenex licenses OGX-011 prior to initiation of registration trials, 25% ifOGX-011 is licensed before 20% of patients have been enrolled in aregistration trial, 20% if OGX-011 is licensed prior to marketing approval and15% thereafter. In addition, Isis currently owns approximately 2% of theoutstanding common stock of OncoGenex.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to discover and develop noveldrugs for its product pipeline and for its partners. The Company hassuccessfully commercialized the world's first antisense drug and has 19 drugsin development. Isis' drug development programs are focused on treatingcardiovascular and metabolic diseases. Isis' partners are developingantisense drugs invented by Isis to treat a wide variety of diseases. IbisBiosciences, Inc., Isis' majority-owned subsidiary, is developing andcommercializing the Ibis T5000(TM) Biosensor System, a revolutionary system toidentify infectious organisms. Isis is a joint owner of Regulus TherapeuticsLLC, a joint venture focused on the discovery, development andcommercialization of microRNA therapeutics. As an innovator in RNA-based drugdiscovery and development, Isis is the owner or exclusive licensee of over1,500 issued patents worldwide. Additional information about Isis isavailable at www.isispharm.com.
This press release includes forward-looking statements regarding Isis'business, its drug discovery and development pipeline, and the therapeuticpotential of OGX-011 for the treatment of cancer. Any statement describingIsis' goals, expectations, financial or other projections, intentions orbeliefs is a forward-looking statement and should be considered an at-riskstatement, including those statements that are described as Isis' goals. Suchstatements are subject to certain risks and uncertainties, particularly thoseinherent in the process of discovering, developing and commercializing drugsthat are safe and effective for use as human therapeutics, and in the endeavorof building a business around such products. Isis' forward-looking statementsalso involve assumptions that, if they never materialize or prove correct,could cause its results to differ materially from those expressed or impliedby such forward-looking statements. Although Isis' forward-looking statementsreflect the good faith judgment of its management, these statements are basedonly on facts and factors currently known by Isis. As a result, you arecautioned not to rely on these forward-looking statements. These and otherrisks concerning Isis' programs are described in additional detail in Isis'annual report on Form 10-K for the year ended December 31, 2007, and its mostrecent quarterly report on Form 10-Q, which are on file with the SEC. Copiesof these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis,""Company," "we," "our," and "us" refers to Isis Pharmaceuticals and itssubsidiaries and joint venture.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals,Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc.Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.
SOURCE Isis Pharmaceuticals, Inc.
