Alnylam And Tekmira Settle RNAi Dispute

A week before they were expected to meet in a Massachusetts courthouse, Alnylam Pharmaceuticals and Tekmira Pharmaceuticals have settled their legal differences and restructured agreements involving delivery technology for RNAi drugs.

Alnylam will pay Tekmira $65 million to dissolve a manufacturing arrangement and a licensing pact for certain Alny­lam products. Alnylam also hands over to Tekmira the intellectual property for the MC3 family of delivery lipids, but Alnylam can use the technology in its own products and sublicense it to partners.

The agreement ends a dispute that began in March 2011 when Tekmira sued Alnylam for misuse of trade secrets related to Tekmira’s lipid nanoparticle (LNP) delivery technology for RNAi. Alnylam filed a countersuit in January 2012 claiming Tekmira had infringed upon its LNP patents.

The companies’ partnership had three facets: licensing agreements that allowed Alny­lam to develop products using Tekmira’s delivery technology, a research collaboration for LNP technology, and a manufacturing pact under which Tekmira made Alnylam products.

Last week’s restructured agreement upends all the prior pacts and sets up a straightforward licensing deal, explains Alnylam CEO John M. Maraganore. “We’re done with them; they’re done with us,” he says. “It’s a divorce.”

Since Tekmira filed suit in 2011, Alnylam has been quietly establishing manufacturing capabilities in Cambridge, Mass. Alnylam says it will be able to produce its own supplies of ALN-TTR02, an RNAi-based treatment for TTR-mediated amyloidosis. Phase III studies of ALN-TTR02 are expected to start in late 2013.