Isis Pharmaceuticals, Inc. and Alnylam Pharmaceuticals, Inc. have formed a new agreement, extending their existing strategic partnership. formed originally in 2004, to lead the development and commercialization of RNA therapeutics. This new agreement includes a cross-license of intellectual property (IP) on four disease targets, providing each company with exclusive RNA therapeutic license rights for two programs. The agreement also includes a non-exclusive technology IP cross-license, providing each company rights to certain of each other's technology advances for RNA therapeutics through April 2019.

Per the terms of the new agreement, Alnylam and Isis are forming an IP cross-license with reciprocal economic terms on four therapeutic targets, where each company obtains exclusive license rights to two therapeutic programs. Alnylam is granting Isis an exclusive, royalty-bearing license to its chemistry, RNA-targeting mechanism and target-specific IP for oligonucleotide therapeutics against two targets: Factor XI and apolipoprotein (a) or Apo(a). Isis is currently developing an investigational antisense drug toward Factor XI for the prevention of thrombosis. ISIS-FXIRx is currently in Phase II clinical development. Isis is also currently developing an investigational antisense drug targeting Apo(a) to treat cardiovascular disease. ISIS-APO(a)Rx is currently in a Phase II clinical trial. In exchange, Isis is granting Alnylam an exclusive, royalty-bearing license to its chemistry, RNA-targeting mechanism and target-specific IP for oligonucleotide therapeutics against two targets: antithrombin (AT) and aminolevulinic acid synthase-1 (ALAS-1). Alnylam is currently developing an investigational RNAi therapeutic targeting AT for the treatment of hemophilia and rare bleeding disorders. ALN-AT3 is currently in a Phase I clinical trial enrolling hemophilia subjects. Alnylam is also currently developing an investigational RNAi therapeutic targeting ALAS-1 for the treatment of hepatic porphyrias, including acute intermittent porphyria (AIP); Alnylam has just filed a clinical trial application (CTA) to begin a Phase 1 clinical trial with ALN-AS1.

The new agreement also includes an extended technology IP cross-license. Specifically, Alnylam is granting Isis a royalty-bearing, non-exclusive license to new platform technology arising from May 2014 through April 2019 for single-stranded antisense therapeutics. In turn, Isis is granting Alnylam a royalty-bearing, non-exclusive license to new platform technology arising from May 2014 through April 2019 for double-stranded RNAi therapeutics. This IP cross-license includes chemistry, motif and mechanism patents, but excludes patent claims on formulations, manufacturing, and specific targets. Under the 2004 agreement, Isis licensed to Alnylam its patent estate related to antisense mechanisms and oligonucleotide chemistry for double stranded RNAi drugs in exchange for a technology access fee, participation in fees for Alnylam's partnering programs and future milestone and royalty payments from Alnylam for programs that incorporate Isis' IP. In turn, Alnylam non-exclusively licensed to Isis Alnylam's patent estate relating to antisense motifs and mechanisms and oligonucleotide chemistry to research, develop and commercialize single-stranded antisense therapeutics, ssRNAi therapeutics and to research double-stranded RNAi compounds. Isis also received a license to develop and commercialize double-stranded RNAi drugs targeting a limited number of therapeutic targets on a non-exclusive basis. Such licenses for RNAi therapeutics were granted by Alnylam in exchange for option fees, and future milestone and royalty payments from Isis for RNAi programs that incorporate certain Alnylam IP.

Source: Isis Pharmaceuticals