Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Re Eisai’s AD pipeline...caving?

I posted yesterday that one of the “hidden correlations” which the AI program detected, and which moved our needle, was the failure of 2 recent BACE inhibitor drugs for AD by Novartis and Amgen. The reason this is correlated is that Eisai, where HH is now installed as VP, Global Affairs, Alzheimer’s, has 2 drugs in their AD pipeline in collaboration with Biogen. One is a BACE inhibitor mechanism of action: Elenbecestat. Same as the 2 which just folded. (Looks like a case of barking up the wrong tree, in which case, fold now, and avoid the rush.)

The second drug is BAN2401, a monoclonal antibody (mab). All other “mabs” have folded including Biogen’s own hyped “promising” drug last year - aducanumab. (This is round 2 for Frazier/Ali...)

Here’s what Biogen’s camp has to say about the prospects of these 2 drugs when asked specifically whether they should continue, at today’s earnings cc.

This is why the AI program moved us up. Without these 2 drugs in the pipeline (both in late phases) Eisai is back to square one. That is not at all unusual for a pharma, but, why bring on HH and promote their sleep/epilepsy guy, and commit to the new G2D2 Center in Cambridge, if they are in development stage? And why the big booth with the waterfall at AAIC2019 where they stated they wanted to be the biggest presence in AD going forward and own that space? (Did you see that display? Cool!)

While Eisai remains committed and may have a strategy, read what Biogen is willing to go on record with as their commitment (audience of shareholders..., hmm. Very noncommittal, imo):

This is from the transcript today, link below.

“Evan Seigerman

Hi, guys. Thank you for taking the question and congrats on the progress. One for Al and Michael, so with the recent failure of BACE inhibitor reported by Amgen, Novartis why does Biogen continue to pursue development of Elenbecestat? And generally given the failure of A Beta antibodies, what gives you the confidence that targeting tau is the right approach for AD?

Michael Ehlers

So Evan, why don’t I take the beginning of this? Of course you know, we’re highly aware of all the announcements in and around BACE inhibitors and recent Novartis and Amgen announcement of termination, they’re discontinuing their BACE inhibitors. So we’re highly aware of this.
I would say patient safety is paramount in our clinical trials, including the Mission AD1 and AD2 trials for the BACE inhibitor that is being conducted in collaboration with our collaboration partner Eisai. Those studies have independent data in safety monitoring board that reviews the data regularly from those Phase III studies.
And to-date the DSMB has recommended the studies proceed. They have an ability to look at that data when they want and they are certainly aware of the likewise the safety signals and discontinuation of other programs and they will be assessing it as it goes along.

As BAN2401, I’ll refer back to what Michel commented on earlier, which is that we are in the midst of very thorough analysis of all the ENGAGE and EMERGE data from aducanumab which is an extensive data set and we would like to have a full understanding of that data before we make a specific development decisions on BAN2401.”


Link below.

As far as the EMERGE ENGAGE data they are studying to determine whether to proceed, that is scrutiny of the failure report of aducanumab as discussed earlier in the transcript. As for whether or not to go forward with Elenbecestat, they have a safety signal (in ph3, that is all he’s willing to commit to) and 2 similars just dropped.

That clears the way for an Eisai expedition to find more promising candidates, as the computer’s takeaway. I would have to agree. And, it’s wise.

Transcript
Biogen Inc. (BIIB) CEO Michel Vounatsos on Q2 2019 Results - Earnings Call Transcript $BIIB
https://seekingalpha.com/article/4276771

GLTA,
Bio