Wednesday, July 8, 2009

Alnylam 1500, GSK 800

In what was possibly greeted in investor circles with a slight yawn, GSK and Alnylam announced today that Alnylam would add 1500 issued or pending RNAi Therapeutics-related patents to GSK’s 800 patent filings into an IP pool designed to facilitate the development of drugs for neglected tropical diseases. So what was this all about?

I do not want to dismiss the value of being a good corporate citizen per se or how it may win Alnylam and RNAi Therapeutics some political goodwill when it comes to charting their way through treacherous regulatory waters. I suspect, however, that there was another message hidden in today's press release. What struck me was that the joint press release emphasized the breadth and quality of Alnylam’s patent portfolio, including by juxtaposing Alnylam’s 1500 patents next to GSK’s 800 and the following quite friendly statement by GSK’s relatively new CEO, Andrew Witty (photo):

“We are delighted that Alnylam will join GSK in this important programme by adding their unique RNAi technology [emphasis mine] to the patent pool.”

This indicates to me that Alnylam and GSK are getting along pretty well. Both managements should be familiar with each other following the GSK-Regulus deal for the development of microRNA therapeutics for inflammatory disease (Regulus is the microRNA joint venture of Alnylam and ISIS). A positive experience there with small RNAs may have given GSK extra incentive to join the ranks of Roche, Takeda, Novartis, and Pfizer in considering RNAi Therapeutics as a bona fide remedy, if not cure for Big Pharma’s stuttering innovation machine and oncoming wave of expiring blockbuster. And yes, Merck is also one of them, and it is likely that when they bought Sirna Therapeutics in 2006, it left GSK looking for a new RNAi Therapeutics partner. Just before that in 2006, GSK and Sirna signed a major RNAi alliance for respiratory disease, and since then Merck has not made the impression that it likes to share its mysterious RNAi know-how.

You know where this is going, and regardless of whether an Alnylam-GSK RNAi platform alliance will actually be announced this year or whether this is just another example of my RNAi delusion, it is worth speculating about the scope of such a potential deal of which we expect at least one this year from Alnylam. Similar to the 2007 Roche platform deal, my guess with regards to therapeutic areas would be oncology, respiratory diseases, metabolic diseases and certain liver diseases. Since these are all areas in which significant improvements have been made in siRNA delivery in the last 2 years, the terms may be even more favorable.

And yes, it would be nice for GSK and Alnylam to combine their expertise in malaria drug development and liposomal siRNA delivery to the liver, respectively, to translate promising pre-clinical results by Alnylam and collaborators into a much needed weapon for a disease that disrupts the lives of up to 500 million people a year mostly in impoverished countries. That RNAi is even considered for such purposes is also a sign that the eventual cost of goods for RNAi Therapeutics should be well below that of recombinant proteins, including monoclonal antibodies, which in turn may be more suitable for vaccination approaches.

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By Dirk Haussecker. All rights reserved.

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