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Saturday, November 17, 2012

Alnylam and Tekmira RNAi Cargo Delivery

Tekmira and Alnylam made the news this week after settling their legal dispute over the use of Tekmiras RNAi delivery technology. According to Xconomy they have:
agreed to resolve all their ongoing litigation, and that the companies have restructured and clarified their relationship, so that Alnylam still has a license to Tekmira’s lipid-nanoparticle delivery technology.
For $65 million dollars Alnylam gets out of the manufacturing contract and they have restructured the licensing agreement for the use of the Tekmira delivery technology.  In 2007 the two companies formed their alliance and further added to it in 2009 with a manufacturing agreement. Then came the accusations from Tekmira that Alnylam was abusing the relationship by using Tekmiras intellectual property to create their own delivery system and sharing information with a third party. One has to wonder why Alnylam would feel the need to improve such an expensive technology that they had researched and selected over the many other options. 

The way forward for these companies? Alnylam is going to take over the manufacturing and Tekmira is going to develop drugs. Xconomy, ever the biotech cheerleaders with a special fondness for Alnylam describes the latest fiasco:

But now each company is on its own, and can’t count on the other side for help. Instead of relying on Tekmira as a contract manufacturer, Alnylam plans to focus on doing in-house manufacturing of the lipid-nanoparticles that it needs to deliver RNAi drugs into cells. The company has been building up that capability for a year, he says, and it has enough capacity to make batches of its lead drug candidate ALN-TTR02 for clinical trials, and into “early commercialization” of the product, Maraganore says. Alnylam also has been focusing on building up internal R&D strength for RNAi delivery. Alnylam’s in-house delivery group developed some new technology that is enabling it to start the first clinical trials later this year with an RNAi drug can be given through a subcutaneous injection—which goes just beneath the skin and is generally more convenient than intravenous delivery.
They have built up manufacturing AND delivery R&D? After laying off a third of their work force in 2010 they turned around and laid off a third of the remaining tribe in 2012. According to Julie M. Donnely at the Boston Business Journal: 
The layoffs include high-level positions including senior director of biotherapeutics, a senior director of business development, a senior director of pharma operations and a senior director of information technology. Nine senior scientists and 14 research associates positions will also be eliminated.
When did Alnylam make this commitment to improving their manufacturing capabilities? What did they do? How much did they invest? Who did they snag from what CMO? What about the delivery system they have developed? What was wrong with Tekmiras? They aren't getting rid of the technology. They've only restructured the agreement. Now they have yet another delivery technology? What is going on with the delivery of RNAi at Alnylam?

Of course we don't really know anything about actual data at Alnylam or Tekmira. Tekmiras claim to become a drug development company is equally as bizarre as the continued existence of Alnylam. They deserved each other. With no clear path, each company will continue to zig zag their way to oblivion. RNAi continues to be our number one Cargo Cult.

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