BioBoyScout op YMB vandaag:
Definitely great news to see JNJ (Janssen) apply for BTD in China, and I'm not at all surprised. Kudos to Joe Trader on Twitter for finding and sharing this news. Ever since JNJ partnered with Arrowhead on ARO-HBV, JNJ has been very quickly and quietly filing and enrolling patients in 10 different trials so far. No doubt that this is all in a concerted effort to get JNJ3989 approved asap for the largest population any drug has ever seen. Right now, any competition is still trying to show decent proof of concept and they have not yet pulled the trigger like JNJ did for all these additional trials, as that requires confidence and a LOT of money and manpower. Every extra month JNJ is able to secure ahead of the competition results in approximately an extra billion or more in revenue. Given that the numbers are that huge, it only makes sense that JNJ would waste no time in pushing these trials as quickly and comprehensively as is possible.
The timing of JNJ's application for BTD in China coincides with the primary completion date of the REEF1 trial. We also know that doctors Locarnini, Gane, Gish, and Yuen (the preeminent experts on HBV and liver diseases) are extremely giddy about this drug and have clearly stopped short of announcing functional cures for the purpose of keeping the information proprietary. IMO, it's just a matter of time, and none of us know the exact protocols (time-wise) that are required for this drug to be approved, HOWEVER, JNJ does know, and their billions in investment in this drug have not eased up, but only intensified.
Numbers-wise for Arrowhead, there is still at least another $1.5+ billion in just milestone revenue alone that is scheduled to come Arrowhead's way from JNJ if all continues to proceed smoothly. That does not include royalties, which in my book, should peek at just over $4.5 billion a year for at least a half dozen years, if not much more. When Arrowhead gets to that point, I have no doubt that massive stock buybacks will be in the works.
Without a doubt, partnering with JNJ on a drug that required a bit of a learning curve with ARC-520 and ARC-521, was the best thing Arrowhead could have done. I do believe that JNJ will see over a trillion in revenue from this drug's lifetime, why? the demand and need is there and the competition is very far behind. You truly need to question if there will even be any competition at all, as the massive investment needed dose pose quite a bit of risk, and remember that the competition has only ONE trigger to hit HBV, and Arrowhead has two that hits across all transcriptomes. This scenario reminds of Dirty Harry where Clint Eastwood says "...you've got to ask yourself one question: 'Do I feel lucky?' Well, do you, punk?". With billions of investment on the line, that will be a super tough decision for any big pharma to make.
So while none of us know the exact timing of when JNJ will release any news on this drug, I am pretty certain that JNJ will act as comprehensively and quickly as is safely possible to get this drug to market so that they can help the hundreds of millions that desperately need this drug. If that means keeping us in the dark for a while longer, then so be it, but the writing is on the wall and there's no denying it.