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Alnylam, Dicerna Form RNAi Therapeutics Collaboration For Alpha-1 Liver Disease

Alnylam Pharmaceuticals, Inc. (ALNY) and Dicerna Pharmaceuticals, Inc. (DRNA) said Monday they have formed a development and commercialization collaboration on investigational RNAi therapeutics for the treatment of alpha-1 antitrypsin or A1AT deficiency-associated liver disease (alpha-1 liver disease).

In addition, the companies have completed a cross-license of their respective intellectual property for Alnylam's lumasiran and Dicerna's nedosiran investigational programs to treat primary hyperoxaluria or PH.

The companies expect these agreements will enhance and accelerate their ability to bring these orphan product candidates to market.

Under the development and commercialization agreement, Alnylam's ALN-AAT02 and Dicerna's DCR-A1AT, two investigational RNAi therapeutics that are in Phase 1/2 development, will be explored for the treatment of alpha-1 liver disease.

Under the agreement, Dicerna will assume responsibility for both ALN-AAT02 and DCR-A1AT at its cost, and may progress one or both of these investigational medicines through clinical development.

Dicerna will select which product candidates to advance in development for the treatment of patients with alpha-1 liver disease. At Phase 3 completion, Alnylam has the no-cost opportunity to opt-in to commercialize the selected candidate in countries outside the U.S., where it already has a commercialization infrastructure in place.

If Alnylam exercises its opt-in right, each party shall pay tiered royalties to the other party based on net product sales generated in its territory at rates dependent on which candidate is commercialized.

If Alnylam waives its commercialization option, Dicerna will retain worldwide rights to commercialize the selected candidates in exchange for milestones and royalties payable to Alnylam. The rate will be dependent on which candidate is ultimately commercialized.

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