CARLSBAD, Calif.--(BUSINESS WIRE)--Regulus Therapeutics Inc. today announced that it achieved the initial milestone with GlaxoSmithKline (GSK) as part of their ongoing worldwide strategic alliance established to discover, develop and market novel microRNA-based therapeutics to treat inflammatory diseases. The two companies are working to identify drugs directed at four different microRNA targets related to inflammatory disease. Regulus has now reached an important discovery milestone, which triggered a payment, concurrent with the first demonstration of a pharmacological effect in immune cells by specific microRNA inhibition. Scientists successfully delivered specific microRNA inhibitors, known as anti-miRs, to mice and clearly identified changes in expression of the genes regulated by the microRNA in immune cells.
“This milestone is further evidence that microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases,” said Peter S. Linsley, Ph.D., Chief Scientific Officer at Regulus. “We believe that we are the leaders in microRNA and are delighted to have such a good partner as GSK supporting the translation of our groundbreaking research into therapeutic opportunities. We are particularly pleased that this has been achieved in the first year of the collaboration.”
The Regulus-GSK alliance, which has a potential value of nearly $600 million, was established in April 2008 to focus on inflammatory diseases. Regulus is responsible for the development of antagonists to four microRNA targets from discovery through completion of clinical proof of concept. GSK has an exclusive license for worldwide development and commercialization of drugs developed by Regulus under each program for the relevant microRNA. The alliance combines Regulus’ unique expertise and comprehensive intellectual property estate in the microRNA therapeutics field with GSK’s extensive inflammatory disease expertise.
About microRNAs
microRNAs are a recently discovered class of genetically encoded endogenous RNAs, approximately 20 nucleotides in length, that are believed to regulate the expression of a large number of human genes. microRNAs have been described as being involved in the regulation of gene expression as part of physiology and development. microRNA-based therapeutics represent a new approach for the treatment of a wide range of human diseases. The inappropriate absence or presence of specific microRNAs in various cells has been shown to be associated with specific human diseases including cancer, viral infection, cardiovascular, metabolic disorders and immuno-inflammatory disease. Targeting microRNAs with novel oligonucleotide therapeutic agents could result in novel and broadly acting treatments for a number of serious human diseases.
About Regulus Therapeutics Inc.
Regulus Therapeutics Inc. is a biopharmaceutical company aiming to discover, develop, and commercialize microRNA-based therapeutics. Regulus aspires to translate one of the most important new discoveries in biology into a novel approach for innovative medicines and to build the leading microRNA company. Regulus was established by Alnylam Pharmaceuticals (Nasdaq: ALNY - News) and Isis Pharmaceuticals (Nasdaq: ISIS - News) in September of 2007 and benefits substantially from their RNA therapeutic drug discovery expertise, unique and established oligonucleotide-based technologies, and a broad and dominant intellectual property estate specific to microRNA-based therapeutics. Regulus’ patent estate includes over 600 patents and more than 300 pending patent applications pertaining primarily to chemical modifications of oligonucleotides targeting microRNA for therapeutic applications. In addition, through its numerous collaborations with academic researchers, Regulus continues to expand its knowledge on the biological role of therapeutically relevant microRNAs. In April 2008, Regulus formed a major alliance with GlaxoSmithKline to explore microRNA therapeutics for immuno-inflammatory diseases. Regulus is headquartered in Carlsbad, California. For more information, visit www.regulusrx.com.
Forward-Looking Statement
This press release includes forward-looking statements regarding the future therapeutic and commercial potential of Isis’, Alnylam’s and Regulus’ business plans, technologies and intellectual property related to microRNA therapeutics being discovered and developed by Regulus, including the relationship between Regulus and GSK. Any statement describing Isis’, Alnylam’s or Regulus’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as such parties’ goals. 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. Such parties’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause their results to differ materially from those expressed or implied by such forward-looking statements. Although these forward-looking statements reflect the good faith judgment of the management of each such party, these statements are based only on facts and factors currently known by Isis, Alnylam or Regulus, as the case may be. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’, Alnylam’s and Regulus’ 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, and in Alnylam’s 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 Isis or Alnylam.
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