The Alnylam-Tekmira
dispute may not be over yet. After de facto losing in the trade secret litigation over SNALP delivery technology, $3B heavy weight Alnylam seems intent
on making life for Tekmira difficult and earn the milestones it is entitled to according to the settlement the hard way.
At least this is
how I interpret the disclosure in the 10-Q quarterly report filed today with
the SEC by Alnylam where the company discloses that it has entered into binding
arbitration with Tekmira over a $5M milestone payment related to liver cancer
candidate ALN-VSP02:
‘In addition, we recently initiated binding
arbitration proceedings to resolve a disagreement with Tekmira regarding the
achievement by Tekmira of a $5.0 million milestone payment under our
cross-license agreement relating to the manufacture of ALN-VSP clinical trial
material for use in China.’
As a reminder, Tekmira was to earn the
milestone for enabling Alnylam’s ALN-VSP partner Ascletis to enter clinical
development in China.
I do not wish to
speculate on the specifics of the dispute, but it is worth remembering that
Alnylam is heavily dependent on rapid clinical development of SNALP-enabled
ALN-TTR02 to support its valuation, especially since the GalNAc platform is
showing additional blemishes (ALN-AT3 delay; admission in the conference call of
certain side effects seen with ALN-TTRsc).
They mentioned about AE but not SAE in the GalNAc platform. AE have been there even in TTR02 program. We need to wait until we get detail report on TTRsc clinical trial before jumping on conclusion. Based on following comments I don't think those AE are very serious in nature.
ReplyDelete"....In deed, we see our proprietary GalNAc conjugate platform as the fast forward for execution on our Alnylam 5x15 pipeline and believe that it now represents the best in class approach for knockdown of liver-expressed disease genes across the industry."
".....Of course as in any clinical study there are adverse events that are reported, but we believe that all of our findings to-date at all dose levels are fully supportive of program advancement."
And remember, they have been dosing as high as 10mg/kg so It is not surprising that they are seeing some AE.
It's strange though that they did not mention anything about AEs (besides the boilerplate 'generally safe and well tolerated') in the 'over-80%-knockdown-PR'. It's possible that the AEs occurred after the PR, but interesting nevertheless that they felt compelled to make such a statement in the CC (nobody asked them, it came from them).
ReplyDeletehttp://www.investorvillage.com/smbd.asp?mb=11383&mn=13388&pt=msg&mid=13027051
ReplyDeleteDirk,
ReplyDeleteIt is prudent on their part to wait until the trial is complete to give all the details when they make their presentation in September. It is also a good practice to be transparent and forewarn investors about AE. They don't want to be like ISIS who misguided their investors about MIPO to the very end.
I expect AE to be similar to TTR02. They are most likely drug related and not GalNAc platform related.
Maraganore may be treading on thin ice regarding the cross-license agreement. Tekmira could pull the plug on licensing SNALP if Alnylam reneges on their end. Or perhaps Maraganore is pursuing a naive strategy to try and nullify the agreement. Either way, I doubt Alnylam shareholders would approve of the shenanigans that management there continues to pursue.
ReplyDeleteTime for a quick post on your take from the latest TKMR conf. call.
ReplyDeleteJudging from your silence on Twitter re: the CC, I'm betting we are treated with an article today. Tekmira seems to be firing on all cylinders and I'm more confident than ever in our future and the future of RNAi, despite Alnylam's immature, ill-conceived tantrums.
ReplyDeleteIn fact, was about to talk about Tekmira getting deeper into TKM-PLK1/cancer, but then felt compelled to write about target selection more generally.
ReplyDeleteAnyway, Tekmira's progress has been solid and without losing financial discipline- as we've come to expect it of them. On the other hand, Tekmira is lacking obvious near-term clinical catalysts so it would be nice to hear something from the business development department.
It just so happens that that TKMR must have been listening to you as they have a opening for a Director of Business Development whom's primary role is to drive partnerships and look for opportunities.. secondary to this hmm.. looks like Steven T Newby has taken a large stake within tekmira per the SEC filing .. he lead one of the only genome focussed funds buying into a 6.x % stake in the company positive things are happening for TKMR.. http://stks.co/bfEG
ReplyDeleteSeems odd for the CEO of ALNY to be selling 3/4 of his portfolio if things are going well.. http://www.mideasttime.com/insider-selling-john-maraganore-unloads-60000-shares-of-alnylam-pharmaceuticals-stock-alny/46239/
ReplyDelete