Regulus Therapeutics, sanofi-aventis partner to develop and commercialize microRNA therapeutics

Regulus Therapeutics Inc. and sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that they have entered into a global, strategic alliance to discover, develop, and commercialize microRNA therapeutics. The alliance represents the largest microRNA partnership formed to date, valued at potentially over $750 million, and includes a $25 million upfront fee, a $10 million future equity investment subject to mutual agreement on company valuation, and annual research support for three years with the option to extend two additional years. The alliance will initially focus on the therapeutic area of fibrosis. Regulus and sanofi-aventis will collaborate on up to four microRNA targets, including Regulus' lead fibrosis program targeting microRNA-21. sanofi-aventis also receives an option for a broader technology alliance that provides Regulus certain rights to participate in development and commercialization of resulting products. If exercised, this three-year option is worth an additional $50 million to Regulus.

“Regulus is very pleased to form this landmark alliance with sanofi-aventis, a leading visionary company developing important new medicines”

microRNAs are a new class of small non-coding RNAs that regulate gene expression by interfering with translation or stability of target messenger RNA transcripts. Endogenous microRNAs regulate the expression of over one-third of all human genes, and the association of microRNA dysfunction with disease phenotypes has given rise to an entirely new class of pharmaceutically relevant targets. In preclinical studies, Regulus has demonstrated that modulating microRNAs can effectively regulate disease pathways and produce therapeutically beneficial effects.

"This new partnership continues to illustrate sanofi-aventis' commitment to develop innovative therapies," declared Marc Cluzel, M.D., Ph.D, Executive Vice-President, Research & Development, sanofi-aventis. "microRNAs are believed to be extremely important in human development and physiology. Together with Regulus we will develop therapeutics which could potentially open a new paradigm in the treatment of major diseases and could offer an attractive new therapeutic approach for patients."

"Regulus is very pleased to form this landmark alliance with sanofi-aventis, a leading visionary company developing important new medicines," said Kleanthis Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus. "The significant support from sanofi-aventis in this new alliance will strengthen our efforts as we continue to build the leading microRNA therapeutics company through our commitment to scientific excellence and advancement of our pipeline of innovative new medicines. Indeed, this landmark alliance will significantly extend our capabilities and resources to lead the discovery and development of microRNA therapeutics."

Alnylam Pharmaceuticals (Nasdaq: ALNY) and Isis Pharmaceuticals (Nasdaq: ISIS) formed Regulus in 2007, with each company currently owning approximately 50% of the preferred stock.

SOURCE Regulus Therapeutics Inc.