Isis and Alnylam Launch Regulus Therapeutics, a Joint Venture to Discover, Develop, and Commercialize microRNA Therapeutics

Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. announced the launch of Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA (miRNA) therapeutics. Because miRNAs regulate whole networks of genes that can be involved in discrete disease processes, miRNA therapeutics represent a new approach to target the pathways of human disease.

Regulus will combine the strengths and assets of Isis' and Alnylam's technologies, know-how, and intellectual property (IP) with strong leadership from a focused management team and Scientific Advisory Board to be chaired by Nobel laureate David Baltimore and include key pioneers in the miRNA field.

Both Isis and Alnylam will grant Regulus exclusive licenses to their IP for miRNA therapeutic applications, as well as certain early fundamental patents in the miRNA field including the "Tuschl III" patent. Alnylam will make an initial investment of $10 million to balance venture ownership; thereafter Isis and Alnylam will share funding of Regulus.

Regulus will be operated as an independent company with an independent Board of Directors and management team. Alnylam and Isis will retain rights to develop and commercialize on pre-negotiated terms miRNA therapeutic products that Regulus decides not to develop either itself or with a partner.

"The emerging biology of microRNAs points to a completely new understanding of cellular mechanisms for regulation of gene expression," said David Baltimore, Ph.D., of California Institute of Technology. "I believe that microRNAs represent previously unexplored disease targets where pharmacological approaches could lead to the emergence of novel therapies for many human disorders. Accordingly, I'm very excited to join in the formation of Regulus and to help build the leading microRNA therapeutics company."