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Isis Pharmaceuticals Adds Two New Drugs to Development Pipeline
Date:1/6/2011

CARLSBAD, Calif., Jan. 6, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it has added two new drugs to its development pipeline, ISIS-FGFR4Rx and ISIS-STAT3Rx.  

ISIS-FGFR4Rx is designed to treat obesity by increasing metabolism, particularly by increasing lipid and fat burning.  ISIS-FGFR4Rx specifically blocks the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissue. In addition, ISIS-FGFR4Rx should not reduce FGFR4 expression in the central nervous system (CNS) or heart, thereby avoiding the CNS and cardiovascular side effects associated with many obesity drugs in development.  In preclinical studies, inhibition of FGFR4 lowered body weight and enhanced weight loss when administered as a single agent, in combination with a caloric-restricted diet and in combination with an appetite-suppressing drug and a caloric-restricted diet.  The reduction in body weight was accompanied by an improvement in insulin sensitivity. ISIS-FGFR4Rx was safe and well tolerated in multiple species.  ISIS-FGFR4Rx is the first drug in Isis' metabolic franchise to treat obesity.  

"Obesity has become an epidemic.  It is a condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers, and an area where most centrally acting drugs have failed due to side-effects.  Consequently, our peripherally acting drugs such as ISIS-FGFR4Rx could have significant therapeutic benefit without the associated central nervous system toxicities that plague many other anti-obesity drugs.  Our ability to selectively target FGFR4 in only the tissues where FGFR4 plays an important role in modulating body weight, makes it an ideal target for our antisense technology," said Sanjay Bhanot, M.D., Ph.D., Vice President, Metabolic Disorders and Head of Translational Medicine at Isis Pharmaceuticals.  "In our preclinical studies, we observed reductions in body fat, reversal of existing obesity and improved insulin sensitivity with ISIS-FGFR4Rx, making this a promising drug with an exciting therapeutic profile."

ISIS-STAT3Rx is designed to treat cancer by inhibiting the production of a gene critical for tumor cell growth and survival.  Signal transducer and activator of transcription 3 (STAT3) is over-active in a variety of cancers, including brain, lung, breast, bone, liver and multiple myeloma and promotes tumor cell growth and prevents cell death.  In preclinical studies, ISIS-STAT3Rx demonstrated antitumor activity in animal models of human cancer with an attractive safety profile.  ISIS-STAT3Rx will be evaluated in a variety of cancers where STAT3 is believed to play a key role such as liver cancers and multiple myeloma.

"Cancer is a therapeutic area in which we believe antisense drugs could have a profound treatment impact.  STAT3 is a target that is widely viewed as promising, but it is inaccessible to traditional drug approaches due to the nature of the protein and its function in the cell," said Brett P. Monia, Ph.D., Vice President, Drug Discovery and Corporate Development.  "ISIS-STAT3Rx adds to our already broad and mature cancer franchise consisting of a Phase 3 drug and three Phase 2 drugs, each with promising clinical data.  These drugs inhibit many of the processes that tumor cells use to grow, proliferate, and metastasize."

Conference Call

At 12:00 p.m. Eastern Standard Time today, January 6, Isis will conduct a live webcast conference call to discuss the new development candidates added to its pipeline and related activities.  Interested parties may listen to the call by dialing 800-295-4740 and refer to passcode "ISIS2011", or access the webcast at www.isispharm.com.  A webcast replay will be available for a limited time at the same address.

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 as well as all aspects of antisense drug discovery, development and manufacturing.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding Isis Pharmaceuticals and the discovery and development of ISIS-FGFR4Rx and ISIS-STAT3Rx.  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, 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.

Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc.  Regulus Therapeutics is a trademark of Regulus Therapeutics Inc.


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SOURCE Isis Pharmaceuticals, Inc.
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