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Press release from PR Newswire

Isis Earns $3 Million Payment as Collaboration With GSK Expands

Monday, May 16, 2011

Isis Earns $3 Million Payment as Collaboration With GSK Expands08:00 EDT Monday, May 16, 2011CARLSBAD, Calif., May 16, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has earned a $3 million payment from GlaxoSmithKline (NYSE: GSK) related to the initiation of a sixth program under its collaboration to discover and develop drugs to treat rare and infectious diseases. This expansion follows the identification of the first development candidate from the collaboration in July of last year."We are pleased to announce this latest development in our alliance with GSK.  In just over a year into this alliance, we have identified our first development candidate, ISIS-TTRRx, which is ready to begin a Phase 1 clinical study. We look forward to achieving further success in the collaboration. Additionally, we recently received recognition from our industry peers for this collaboration by receiving the Breakthrough Alliance Award of 2011 sponsored by Deloitte Recap," said B. Lynne Parshall, Chief Operating Officer and CFO of Isis.  "We and GSK are committed to working together to apply antisense technology to develop new treatments for rare and severe diseases.  We benefit from GSK's expertise as we move these programs forward."Isis entered into a strategic alliance with GSK in March 2010 to develop RNA therapeutics.  With the latest $3 million payment, Isis has earned $38 million in upfront payments from GSK.  Under the terms of the agreement, Isis 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.  Isis is eligible to receive on average up to $20 million in milestone payments per program up to Phase 2 proof-of-concept.  GSK will have the option to license compounds at proof-of-concept and will be responsible for all further development and commercialization.  In addition, Isis will receive up to double-digit royalties on sales from any product that is successfully commercialized.  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 24 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 has designed and executed a patent strategy that has provided the Company with strong and extensive protection for Isis' drugs and technology.  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 drugs.  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, 2010 and its most recent quarterly 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., its jointly owned subsidiary.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, both of Isis Pharmaceuticals, Inc.