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Isis, Alnylam Extend RNA Development Pact

Includes cross-license for two programs targeting thrombosis and cardiovascular disease

Isis Pharmaceuticals and Alnylam Pharmaceuticals have formed a new agreement, extending their existing strategic partnership from 2004 for 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 cross-license, providing each company rights to certain technology advances for RNA therapeutics through April 2019.

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-FXI is currently in Phase II development. Isis is also currently developing an investigational antisense drug targeting Apo(a) to treat cardiovascular disease, also in Phase II development.

In exchange, Alnylam has an exclusive 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 trial in hemophilia, and ALAS-1 for the treatment of hepatic porphyrias, will soon begin a Phase I trial.

“Isis and Alnylam lead the RNA-targeted therapeutics space and are innovators in understanding the science and developing the technologies to support RNA-targeted drug discovery. At Isis, we have dedicated ourselves to advancing the core understanding of RNA-based drugs, continually evolving and optimizing our technology and creating an extensive IP position. We believe that providing access to our IP supports our business strategy of generating revenue from our partners while focusing our efforts on our internal programs and promising pipeline of maturing products,” said Stanley T. Crooke, M.D., Ph.D., chief executive officer of Isis Pharmaceuticals.”

“We have each benefited enormously from our long-standing collaborative efforts over the last decade. We believe that our collaboration has enabled both companies to succeed as leaders in the development and commercialization of RNA therapeutics,” said John Maraganore, Ph.D., chief executive officer of Alnylam. “This extended agreement adds a new feature, enabling further advancement of specific therapeutic programs on an exclusive basis, while allowing for the continued sharing of IP on technology. Based on the benefit that we believe innovative RNA therapeutics may bring to patients across a broad range of diseases, we look forward to continued success for both companies.”

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