NKTR has had the data in hand for well over one month, enough time to clear up problems. I think NKTR intentionally kept the results blinded prior to the CC. It was the ethical thing to do. It takes several weeks minimum after the data is unblinded to create an appropriate corporate response, whether the data are good or bad. There wasn't enough time prior to the earnings release for that to happen. HR acknowledged it in early January.
To avoid creating the appearance of misleading the public one way or another, the best thing to do is to keep the data blinded. But now that the CC is over, it's time to unblind. It doesn't take very long to do simple topline analysis to see whether the primary endpoint was met. It takes longer to do the secondary endpoint and subset analysis. The biomarker research adds complexity. It takes even longer to craft an appropriate corporate strategy and how to present it to the public. I believe that process is underway right now.
It looks like no one else is answering your question. BEACON results will be out by the end of March. The company was blinded to the results at the time of the earnings release on Tuesday. But I'll bet you anything that two seconds after the CC completed, HR immediately directed company analysts to unblind the data. I wouldn't be surprised if the topline results are known right now.
Because single agent irinotecan isn't the standard of care, only 80 patients signed up for this trial in five years. I believe NKTR stated that a lot of this trial was done in India, where access to current standard-of-care drugs isn't always a given.
Don't forget the CRC study, 102+Erbitux vs. irinotecan+Erbitux, another dead end. On the other hand, MACK's better irinotecan MM-398 has been successfully combo'd in FOLFIRI to treat metastatic pancan. I'm sure there will be other improved-FOLFIRI studies coming, CRC is a big one. You can have the best drug in the world, but if you can't apply it correctly, it doesn't do anyone any good.
Even if statistical significance was achieved, it is doubtful that 102 would be approved. Single agent irinotecan isn't the standard of care for CRC. Might as well shut it down. Kind of disappointing that 102 could
not achieve stat-sig over irinotecan. Hope that's not an omen for BEACON.
Bayer does have a pegylated Factor VIII product under development. BAY 94-9027 has completed its Phase 2/3. FDA and EMA submission is expected in 2H15.
I'll throw in my two cents.
I do not think there is a problem on how BEACON is being run. To the contrary, BEACON is a model of how a Phase 3 should be designed and executed. If BEACON succeeds, I doubt there will be any issues regarding the study protocol.
Here are things that can be questioned. One issue is the limited Phase 2 data that formed the basis for the Phase 3. Phase 2 was single arm with only 35 patients at the dosage being tested in Phase 3. The results weren't totally compelling. In yesterday's CC, there were analyst questions about NKTR's use of single arm studies in Phase 2. Today's standard is to run controlled Phase 2's, really a mini Phase 3. NKTR's response didn't seem very convincing. A second issue is the use of single agent NKTR-102. Irinotecan is typically used in combination treatments. MACK's successful enhanced irinotecan study against pancreatic cancer substituted MM-398 for irinotecan in FOLFIRI.
Inhaled Amikacin is a wildcard. The 30% royalty is quite juicy. I'm not sure how fast NKTR can ramp up manufacture of the inhalers. After years in the doldrums, antibiotics are now a hot product, see the CBST buyout. We need to keep an eye on potential competition.
Only if "CRUSHED" is a synonym for confirmed.
We got your volume today. Lots of volatility, some want out, others want in.
BAX-855 is the best bet for monetization. Most preapproval candidates these days don't get as much upfront as HR negotiated for Movantik a few years ago. It's among the best deals I've ever seen, I give credit to HR for that. Do you think lightning will strike twice?
I don't delete threads, if it's missing it's because of the cr-ppy Yahoo (jerks) message boards.
If you consider the early 2020's at best for 102 approval (if BEACON fails) as a vital company asset, who am I to disagree.
Doberstein presented BAX-855 royalties in a CC a few months ago. He stated 5% under $1.2B, 13% over. Let's do the math, sales vs. royalties. I believe the ramp will be a few hundred million per year (which is faster than Eloctate), and it won't be a significant driver until the end of the decade. I wouldn't be surprised if HR elects to sell off the stream to Royalty Pharma, like he did other assets, for quick cash.
Beyond DTC ads (I was hoping to see a Super Bowl ad promoting Movantik showing some sweating addict straining on the can), AZN has to get Movantik on insurance formularies as a preferred drug. To get a feel for that, check your health insurance policy over the next few months. Then there is the physician education process. Since Movantik works well within 24 hours of usage, don't be surprised if it is used as needed rather than daily by many people, especially if there is a large copay. I feel politically incorrect saying this, but there is a good chance that diversion could be an important driver of sales.
--Why dont you come up with some positive info for a change
Except maybe for hijacked and occasionally cow, no one identifies risk items. It seems like the only risk most posters see is whether NKTR goes to 500pps instead of 700pps. How do you model the future earnings of NKTR?
Most important point. With milestone payments going away, there are two main drivers.
1. How fast will Movantik ramp?
2. Can NKTR score another partnership?
Everything else is in the noise.
NKTR is burning over $200M cash in 2015, consistent with previous years. Even with the $140M milestone payments, the company anticipates negative cash flow of over $60M. 2015 is the final year of milestone payments, NKTR will then be living off royalties absent another partnership. HR talks about becoming cash flow positive. With 20% royalty for Movantik and 5% for BAX-855, do the math. What sales levels will it take for the cash flow to turn positive? Don't forget the $125M bond coming due in a few years.
Anticipate further dilution.
It's like I said, approval would me m-a-n-y years off for any other application. Figure five years from study announcement to approval. But how soon might another Phase 3 start? Here's what HR says about it in the CC. It will be at least 2017 before NKTR has a good handle on the cash flow. You're looking well into the 2020's.
"So whatever we do in the future is also going to depend on the ramp up of MOVANTIK and the ramp in how well BAX 855 does. I mean MOVANTIK and BAX 855, does. MOVANTIK themselves should be able to generate, as I said, a casual that moves us towards cash flow of positive. And given the NKTR-102 metastatic breast cancer results positive or negative. If they are positive great, if they are negative how negative are they. There is a lot of moving pieces to this in both the science side and the cash side as well. So I don’t want you to think that the first thing we are going to do is in the event have a failed Phase 3 study run out and start five Phase 3 studies in various indications, of course we are not going to do that. We are very conscious of how we use our cash..."
One of the points of the Phase 2 was to differentiate the efficacy of NKTR-181 from ibuprofen. Patients who took ibuprofen only during the withdrawal period should have experienced less pain relief than those who took NKTR-181. That didn't happen. The Phase 2 did not demonstrate the difference in analgesic function between ibuprofen and NKTR-181, nor will the Phase 3 as NKTR has described it so far. It does need to be demonstrated at some point.
You beat me to it, corona.
ALKS-7106 was an attempt at a opioid painkiller without the side effects and addiction potential. Like NKTR-181, ALKS-7106 is a molecule, not a formulation. According to preclinical data, ALKS-7106 is thirty times more potent than morphine. It failed efficacy in Phase 1 and ALKS is dropping it. But you know, I wouldn't be surprised if some biodreck company picks it up.
Efficacy of NKTR-181 is still unresolved. It appears that NKTR has dropped its plan to run an efficacy study before embarking on the full blown Phase 3. Here is an important difference between the failed NKTR-181 Phase 2 and the proposed Phase 3. The control for the Phase 2 was ibuprofen, an NSAID. The control for Phase 3 is placebo. Phase 2 success would have clearly demonstrated that NKTR-181 is clearly a superior painkiller to the NSAID's. The Phase 3 design won't show that. Superiority is essential for a successful product. Further study beyond what NKTR has discussed for NKTR-181 will be necessary to differentiate efficacy from the NSAID's.