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Alnylam, Merck Amend R&D Collaborations to GiveMerck an Earlier Role; Alnylam to See Cash Sooner

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Alnylam Pharmaceuticals said this week that it has amended and consolidated its RNAi-based drug-development deals with Merck into a single ongoing collaboration in order to give Merck a more active role in the development process, signaling an increased commitment by the big pharma in RNAi as a therapeutic modality.

Alnylam noted that, under the new deal, it could receive milestone payments of more than $120 million based on the successful commercialization of three RNAi drugs solely by Merck.

As part of the restructuring, Alnylam also said that the companies will halt their efforts to develop RNAi-based treatments for ocular diseases. As such, Alnylam has regained the full rights to ALN-VEG01, a VEGF-targeting siRNA drug that was being developed for age-related macular degeneration.

Alnylam said it is evaluating partnership opportunities for ALN-VEG01.

Merck and Alnylam began working together in September 2003 when they struck a five-year alliance to develop RNAi-based therapeutics against Merck-defined targets, as well as related technologies (see RNAi News, 9/12/2003).

Almost a year later, the companies inked another drug-development deal, this one focusing on RNAi drugs for ocular diseases and encompassing Alnylam's then-active AMD program (see RNAi News, 7/2/2004). Alnylam, however, shelved ALN-VEG01 last September, calling the field too competitive (see RNAi News, 9/23/2005).

Under the companies' revised arrangement, the partners will still focus on nine undisclosed therapeutic targets to be named by Merck, but now Merck may participate at an earlier stage of the research and development process. Originally, initial development of the RNAi drug candidates was to be carried out by Alnylam alone, with Merck deciding later if it wanted to participate in the R&D effort.

Alnylam noted that the nine targets are in addition to a preclinical spinal cord injury program, focusing on a target within the NOGO pathway, that was selected for development by Alnylam under the companies 2003 agreement (see RNAi News, 1/28/2005).

Also under the new terms of the alliance, Alnylam may select three of the nine new programs for joint development in which Merck will participate from the beginning — providing Alnylam with R&D funding earlier on. Under the companies' original deal, Alnylam would not receive funding until predefined preclinical work had been completed.

Alnylam will have the right to co-promote drugs developed through these three programs in the US. Merck will be responsible for commercializing the other six, with Alnylam receiving milestones and royalties.

Officials from Alnylam and Merck were not available for comment by press time.

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