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Press release from PR Newswire

Isis Earns $5 Million Milestone Payment From GSK for Designation of a Development Candidate to Treat an Undisclosed Rare and Serious Disease

Thursday, July 29, 2010

Isis Earns $5 Million Milestone Payment From GSK for Designation of a Development Candidate to Treat an Undisclosed Rare and Serious Disease07:00 EDT Thursday, July 29, 2010CARLSBAD, Calif., July 29 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it has earned a $5 million milestone payment from GlaxoSmithKline (NYSE: GSK) related to the designation as a development candidate of a drug to treat an undisclosed rare and serious disease.  Isis will develop the drug to Phase 2 proof-of-concept, at which time GSK has the option to license it.   "We are pleased to have achieved this milestone so early in our collaboration with GSK.  This alliance is an important step in enhancing our focus on rare disease, and we are excited to move our third drug in this area into our pipeline," said Stanley T. Crooke, M.D., Ph.D., Chairman and Chief Executive Officer of Isis.  "Under this new model of partnership we are able to retain control of this asset to facilitate its rapid development, while benefiting from GSK's expertise and new focus in rare diseases, and financially, from milestone payments even before GSK exercises its license option at Phase 2 proof-of-concept." In March 2010, Isis entered into a strategic alliance with GSK to develop RNA therapeutics for rare and infectious diseases.  Under the terms of the agreement, which covers up to six programs, Isis received an upfront $35 million payment from GSK and is eligible to receive license fees and milestone payments, totaling nearly $1.5 billion, in the event all six programs are successfully developed for one or more indications and commercialized through to pre-agreed sales targets.  The alliance applies Isis' antisense drug discovery platform to discover and develop new therapeutics against targets for rare and serious diseases, including infectious diseases and some conditions causing blindness.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 23 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 approximately 1,600 issued patents worldwide.  Additional information about Isis is available at www.isispharm.com.This press release includes forward-looking statements regarding Isis' collaboration with GlaxoSmithKline and Isis' research and development opportunities in disease areas including rare and infectious diseases.  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, 2009 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.SOURCE Isis Pharmaceuticals, Inc.For further information: Kristina Lemonidis, Director, Investor Relations, +1-760-603-2490, or Amy Blackley, Ph.D. Assistant Director, Corporate Communications, +1-760-603-2772