8-KEarnings & ResultsLeadership ChangesMaterial Agreements+1

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Nov 4, 2009)

Filed November 4, 2009For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) filed an 8-K on November 4, 2009, reporting significant advancements in its strategic collaborations and its financial results for the third quarter of 2009. The company has deepened its relationship with Roche, initiating a new therapeutic collaboration stage focused on the co-discovery and development of specific RNAi therapeutic products. This expanded alliance involves contributions of key delivery technologies from both parties and a potential for co-development and co-commercialization in the U.S. market, with milestone and royalty payments for the rest of the world. Additionally, Alnylam amended its collaboration agreement with Cubist Pharmaceuticals to concentrate efforts on ALN-RSV02 for pediatric RSV infections, with both companies sharing development costs. Alnylam will independently develop ALN-RSV01 for adult transplant patients, retaining control and sole expense for this program, though Cubist retains an option to re-engage. These strategic moves underscore Alnylam's efforts to advance its RNAi pipeline through partnerships.

Key Highlights

  • 1Alnylam and Roche advanced their license and collaboration agreement (LCA) into a new therapeutic collaboration stage, focusing on the discovery and development of specific RNAi therapeutic products.
  • 2The expanded Roche alliance includes co-development and potential co-commercialization in the U.S. for RNAi therapeutic products, with milestone and royalty opportunities for Alnylam in ex-U.S. markets.
  • 3Alnylam and Cubist amended their collaboration agreement to prioritize the development of ALN-RSV02 for pediatric RSV infections, sharing development costs for this second-generation compound.
  • 4Alnylam will independently develop ALN-RSV01 for adult transplant patients at its own expense, with Cubist holding an opt-in right under certain conditions.
  • 5The company reported its financial results for the quarter ended September 30, 2009, via a press release furnished as an exhibit.
  • 6Edward Scolnick, M.D., informed the company that he will not stand for re-election as a Director at the 2010 Annual Meeting of Stockholders.

Frequently Asked Questions

The advancement signifies a deepening of the collaboration, moving into a 'therapeutic collaboration stage' where Alnylam and Roche will jointly discover and develop specific RNAi therapeutic products. This includes potential co-development and co-commercialization in the U.S., which could lead to significant future revenue streams for Alnylam through milestone payments and royalties.

The amendment shifts the primary focus to ALN-RSV02 for pediatric RSV infections, with Alnylam and Cubist sharing development costs. Alnylam will now develop ALN-RSV01 for adult transplant patients independently and at its own expense, though Cubist retains an option to re-enter the collaboration on ALN-RSV01 in the future.

The 8-K filing includes a press release detailing Alnylam's financial results for the quarter ended September 30, 2009. While the details of the results are not in the 8-K itself, they were made public through the furnished press release.

Yes, Edward Scolnick, M.D., has informed the company that he will not seek re-election as a Director at the 2010 Annual Meeting of Stockholders. He will continue to serve on the board until the remainder of his current term.