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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Apr 6, 2020)

Filed April 6, 2020For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) has entered into two significant agreements with Dicerna Pharmaceuticals, Inc. The first is a Patent Cross-License Agreement concerning their respective investigational RNAi therapeutics for primary hyperoxaluria (PH). Under this agreement, both companies gain freedom to develop and commercialize their PH candidates, lumasiran (Alnylam) and nedosiran (Dicerna), with reciprocal royalty payments based on net sales. The second agreement establishes a development and commercialization collaboration for investigational RNAi therapeutics targeting alpha-1 antitrypsin (A1AT) deficiency-associated liver disease. Dicerna will lead the development of both Alnylam's ALN-AAT02 and Dicerna's DCR-A1AT. Alnylam has a future option to co-commercialize the chosen candidate(s) outside the U.S. These strategic collaborations aim to advance promising treatments for rare diseases and provide Alnylam with enhanced flexibility and market access.

Key Highlights

  • 1Alnylam and Dicerna entered into a Patent Cross-License Agreement for their primary hyperoxaluria (PH) investigational RNAi programs (lumasiran and nedosiran).
  • 2This agreement grants each company non-exclusive cross-licenses, allowing freedom to develop and commercialize their respective PH treatments.
  • 3Reciprocal royalty payments are established: Alnylam to pay mid- to high-single-digit royalties on lumasiran sales to Dicerna, and Dicerna to pay low-single-digit royalties on nedosiran sales to Alnylam.
  • 4A Development and Commercialization Agreement was formed for investigational RNAi therapeutics targeting alpha-1 antitrypsin (A1AT) deficiency-associated liver disease.
  • 5Dicerna will lead the development of both ALN-AAT02 (Alnylam) and DCR-A1AT (Dicerna) for alpha-1 liver disease at its own cost.
  • 6Alnylam has a no-cost option to opt-in for U.S. commercialization rights for a selected candidate upon completion of Phase 3 development.
  • 7Both agreements are subject to customary conditions, including antitrust review (Hart-Scott-Rodino).

Frequently Asked Questions

The agreement aims to resolve potential intellectual property conflicts and provide both Alnylam and Dicerna with the freedom to operate and commercialize their respective investigational RNAi therapies for primary hyperoxaluria (PH). This means Alnylam can proceed with lumasiran and Dicerna with nedosiran without significant IP hurdles from the other party.

Alnylam will pay Dicerna mid- to high-single-digit royalties on global net sales of lumasiran. Conversely, Dicerna will pay Alnylam low-single-digit royalties on global net sales of nedosiran. This structure reflects the licensing of intellectual property related to each company's product.

Dicerna will manage and fund the clinical development of both ALN-AAT02 and DCR-A1AT. Alnylam retains a valuable option to opt-in to commercialize the selected candidate(s) outside the U.S. upon successful Phase 3 trials. If Alnylam exercises this option, it can leverage its existing commercial infrastructure and share in future revenues through tiered royalties paid to Dicerna, while receiving its own royalties if Dicerna commercializes.

Yes, both agreements are subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as well as other customary closing conditions. This ensures compliance with antitrust regulations.