OGX-011 Phase 3 Studies in First- and Second-Line Advanced Prostate Cancer and Non-Small Cell Lung Cancer Expected to Begin in 2010 and Early 2011 CARLSBAD, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (NASDAQ:ISIS) today announced that it will receive a $10 million payment from OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) as a result of OncoGenex' license of OGX-011 to Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). OGX-011 is a second-generation antisense drug co-discovered by Isis and OncoGenex that has completed a successful Phase 2 program in patients with advanced prostate cancer and advanced non-small cell lung cancer. Teva and OncoGenex will collaborate on a global Phase 3 clinical program for OGX-011 in patients with prostate and non-small cell lung cancer. "We are pleased with OncoGenex' selection of Teva Pharmaceuticals, a leading pharmaceutical company, as a partner to complete the development and commercialization of OGX-011. OGX-011 will be the second antisense drug to enter Phase 3 development from our second-generation antisense technology. We are encouraged by the Phase 2 results of OGX-011 presented earlier this year in patients with advanced prostate cancer and look forward to the drug progressing into a broad Phase 3 program," said B. Lynne Parshall, COO and CFO of Isis Pharmaceuticals. "2009 has been an eventful year for Isis' satellite companies, continuing to affirm our strategy of maximizing the value of our antisense drug discovery platform with both traditional and unique partnerships. Not only do these relationships provide continuing short-term benefit, but, as drugs move forward in the hands of capable partners, they promise significant benefit to patients and more significant financial rewards to Isis in the future." Under the terms of OncoGenex' agreements with Teva, Isis will receive $10 million of the upfront monies paid. This constitutes 30% of the $20 million license fee and 30% of the premium on Teva's equity investment in OncoGenex as well as a portion of the $30 million prepaid development costs that OncoGenex will subsequently contribute to the development of OGX-011. Isis will also receive 30% of the up to $370 million in milestone payments OncoGenex is eligible to receive in addition to 5.5 - 7% royalties on all sales of OGX-011. ABOUT ISIS PHARMACEUTICALS, INC. Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 21 drugs in development. Isis' drug development programs are focused on treating cardiovascular, metabolic and severe neurodegenerative diseases and cancer. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Isis and Alnylam Pharmaceuticals are joint owners of Regulus Therapeutics Inc., a company focused on the discovery, development and commercialization of microRNA therapeutics. Isis also has made significant innovations beyond human therapeutics resulting in products that other companies, including Abbott, are commercializing. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,600 issued patents worldwide. Additional information about Isis is available at http://www.isispharm.com/. ISIS FORWARD LOOKING STATEMENT This press release includes forward-looking statements regarding Isis' business, its collaboration with OncoGenex Pharmaceuticals, its financial and business development activities, and the development activity, and the therapeutic potential of OGX-011 in treating patients with cancer. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2008, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of 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 its subsidiaries, including Regulus Therapeutics Inc. Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics Inc. DATASOURCE: Isis Pharmaceuticals, Inc. CONTACT: Kristina Lemonidis, Director, Investor Relations, +1-760-603-2490, or Amy Blackley, Ph.D., Assistant Director, Corporate Communications, +1-760-603-2772, both of Isis Pharmaceuticals, Inc. Web Site: http://www.isispharm.com/

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