8-KMaterial Agreements

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jan 15, 2009)

Filed January 15, 2009For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced on January 15, 2009, a significant development in its RNAi technology pipeline through a License and Collaboration Agreement with Cubist Pharmaceuticals, Inc. This agreement focuses on the development and commercialization of RNAi-based therapeutic products for respiratory syncytial virus (RSV) infections. The collaboration includes Alnylam's lead RSV candidate, ALN-RSV01, currently in Phase II trials, along with pre-clinical second-generation inhibitors. Key terms involve a $20 million upfront payment from Cubist to Alnylam, with additional potential milestone payments totaling up to $82.5 million for global rights outside of Asia. The companies will co-develop products in North America, sharing costs and profits, and Cubist will have exclusive, royalty-bearing rights in other territories. Alnylam also retains an option to convert the North American co-development arrangement into a royalty-bearing license, potentially unlocking further milestone payments.

Key Highlights

  • 1Alnylam entered into a License and Collaboration Agreement with Cubist Pharmaceuticals for RNAi-based RSV therapeutics.
  • 2The agreement includes Alnylam's ALN-RSV01 (Phase II) and other pre-clinical RSV inhibitors.
  • 3Cubist will pay Alnylam $20 million upfront.
  • 4Potential milestone payments for Alnylam total up to $82.5 million in the global territory (excluding Asia) and up to $130.0 million if Alnylam opts to convert North America to a royalty-bearing license.
  • 5Alnylam and Cubist will co-develop products in North America, sharing costs and profits.
  • 6Cubist gains exclusive, royalty-bearing rights for commercialization in territories outside North America and Asia.
  • 7The agreement establishes a six-year exclusivity for therapeutic products targeting RSV, with specific patent expiry dates estimated between 2016 and 2026.

Frequently Asked Questions

The agreement focuses on the development and commercialization of therapeutic products utilizing Alnylam's RNA interference (RNAi) technology for the treatment of respiratory syncytial virus (RSV) infections.

Alnylam received a $20 million upfront payment from Cubist. Additionally, Alnylam is eligible for milestone payments up to $82.5 million for global territories (excluding Asia) and potentially up to $130.0 million if it converts the North American co-development arrangement into a royalty-bearing license. Alnylam will also receive double-digit royalties on net sales in the Royalty Territory.

In North America, Alnylam and Cubist will share development responsibilities and costs equally, with Cubist holding the sole right to commercialize, and profits/losses split equally. Outside of North America and Asia, Cubist will have exclusive rights to develop and commercialize the licensed products on a royalty-bearing basis.

Alnylam has the right to convert the North American co-development and profit-sharing arrangement into a royalty-bearing license. If exercised, North America would become part of the 'Royalty Territory,' and Alnylam would become entitled to additional milestone payments in addition to royalties on net sales in North America.