8-KMaterial Agreements

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Feb 4, 2013)

Filed February 4, 2013For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced a significant development on February 4, 2013, with the entry into a material definitive agreement, specifically a license and collaboration agreement with The Medicines Company (MedCo) for RNA interference (RNAi) therapeutics targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). This agreement focuses on the development and commercialization of RNAi therapeutics for hypercholesterolemia and related diseases, including ALN-PCS02 (Phase I) and ALN-PCSsc (pre-clinical). This partnership is a key event for Alnylam, as it provides a substantial upfront payment and milestone potential, while also advancing its pipeline towards commercialization. The MedCo Agreement grants MedCo exclusive worldwide rights to develop, manufacture, and commercialize PCSK9-targeting RNAi therapeutics. Alnylam will receive a $25.0 million upfront payment and is eligible for up to $180.0 million in future clinical development, regulatory, and commercial milestones, plus double-digit royalties on net sales. Alnylam will manage initial development through Phase I completion, with MedCo assuming subsequent development and commercialization responsibilities at its own cost. This strategic collaboration is designed to leverage Alnylam's RNAi platform while de-risking its pipeline and providing crucial funding for further research and development.

Key Highlights

  • 1Alnylam Pharmaceuticals entered into a license and collaboration agreement with The Medicines Company (MedCo) on February 3, 2013.
  • 2The agreement grants MedCo exclusive worldwide rights to develop, manufacture, and commercialize PCSK9-targeting RNAi therapeutics for hypercholesterolemia.
  • 3Alnylam will receive a $25.0 million upfront cash payment from MedCo.
  • 4The Company is eligible for up to $180.0 million in future milestone payments tied to clinical development, regulatory approvals, and commercial success.
  • 5Alnylam will also receive scaled double-digit royalties on worldwide net sales of the licensed products.
  • 6The collaboration includes two product candidates: ALN-PCS02 (Phase I) and ALN-PCSsc (pre-clinical).
  • 7Alnylam retains responsibility for initial development through Phase I completion, with MedCo taking over all subsequent development and commercialization responsibilities at its own expense.

Frequently Asked Questions

The agreement allows Alnylam Pharmaceuticals to out-license its PCSK9-targeting RNAi therapeutics, ALN-PCS02 and ALN-PCSsc, to The Medicines Company for development, manufacturing, and commercialization. This partnership aims to advance these potential treatments for hypercholesterolemia and related diseases.

Alnylam received an upfront payment of $25.0 million. They are also eligible for milestone payments totaling up to $180.0 million upon achieving specific development, regulatory, and commercial goals, and will receive double-digit royalties on future net sales.

Alnylam is responsible for the further development of the licensed products through Phase I completion, at its cost up to an agreed-upon cap. After Phase I, The Medicines Company will assume all development and commercialization responsibilities at its sole cost.

The agreement focuses on two RNAi therapeutics targeting PCSK9: ALN-PCS02, which has completed Phase I clinical trials, and ALN-PCSsc, which is in pre-clinical development. The parties intend to select one of these for ongoing development at a later stage.