AZN did mention NKTR-118
from AZN R&D pipeline presentation:
Let’s now look at some of our late stage trial programs.
NTKR-118, an oral, peripherally acting opioid antagonist which we are developing with Nektar Therapeutics, moved into phase 3 and is being investigated for the treatment of opioid induced constipation, or OIC.
Opioids are widely prescribed in pain management, with over 250 million prescriptions written annually in the US alone.
And some 50% of patients taking them long term suffer from constipation. Of these, only 40 to 50% gain effective relief with current treatments.
NKTR-118 is designed to block opiate receptors in the GI system and thus alleviate OIC without counter-acting the analgesic effects of opiates in the brain.
The phase 3 KODIAC program started enrolling in March. It consists of two efficacy studies of 630 patients each, which compare two doses of NKTR-118 and placebo. A 52-week long-term safety study assigns patients to open-label treatment of either NKTR-118 versus traditional treatment chosen by the physician. KODIAC also includes one 4-week study of patients with cancer-related pain.
Building on results from phase 2, KODIAC will aim to establish a substantially improved lower GI function by increasing the frequency of spontaneous bowel movements in patients with OIC, while simultaneously preserving opioid mediated analgesia.
The first regulatory filing of NKTR-118 is being planned for 2013.
"I'd be very curious what people inside the organisation would have to say in depositions under oath"
The way things are going, there won't be many people left to testify. In addition to the COO and CMO, there are about 10 open management positions last time I looked. But it does seem that supoenas are about the only way you're gonna get information out of these clowns.
Litigation would help nobody at this point, and I don't think that would be the most solid argument in any case. The way the Bayer delays were portrayed, the nature of the deal collapse/change of plans, the management changes. I'd be very curious what people inside the organisation would have to say in depositions under oath. In the end the lawyers would benefit most. Best to serve notice individual investors are not too happy and have lost trust in his honesty and judgement. The way the Lorianne change seems to be going down is a shining example. If mistakes were made it's not just the individual, but the people who put them in positions over their head that are accountable.
For now I think watching as carefully and critically as possible is the best plan, but if there are a few more eyebrow raising changes of story or plan then I would be interested in utilizing litigation to pry the truth of the situation into the open. Right now it looks like standard over optimism + over promising. If it starts to look like something more dangerous to my investment I'll be interested in joining with others to do more. If you are in a car and you think you got a drunk at the wheel it's best to act. It's really not about the PPS decline for me, but some of the events that enabled it to occur to the extent that it has are concerning.
"via litigation "
Yes, speaking of litigation, i think we have a case against HR for lying to us by saying "the 102 results were so good we decided to keep it for ourselves."
Keep in mind that as of that time the idea for pursuing 102 was to provide the cancer patients for a product with less side effects than Irenotecan rather than the new sub-sub treatment for OC which is a pie in the sky.
It seems to me as things have unfolded, it is obvious that HR lied to us about 102.
I tend to agree she is gone, and they have been in keeping up appearances mode until an official release. I also believe that news partially rolled into the PPS decline. People certainly knew in advance. Regardless of any real impact the roll over of 2 high level execs. in recent memory does not look good. Especially when there is no feeling of openess and honesty about the whole situation. There is huge value here IMO, but I'm concerned the people we have put in charge of exploiting that potential are looking like the gang that couldn't shoot straight.
Some advice for 8/4. HR DO NOT bs the situation. Any negatives need to be addressed, here is what happened and why.
Among the headscratchers we have to date: NKTR-102 deal/no deal, Bayer NKTR-061 deal pushed back, back,...then waaay back is it as presented about finalizing a device or manufacturing enough devices (it's never been clarified what the issue actualy is. Dancing around it is/was unnacceptable). NKTR-102 development plan. CRC where exactally do we stand here? Info LONG overdue. Recruiting the comparator excuse is worn out. Debt due in 2012 what is the plan? Pay it off, push it back with a refinancing... If NKTR-102 go it alone PIII is still the play how do we get to the end goal without additional dilution? Trust has been squandered IMO your salary is way too large to view the same rehash as acceptable. All the investors are entitled to an clear picture/explanation (not just the institutional investors, who may have a direct line). Keep making people feel like they aren't getting the information they are entiteld to as OWNERS of the company, and they/we may go after in via litigation and that benefits nobody
If I had to guess, the decision to terminate LM occurred after the FDA held its post-PII O/C meeting with NKTR in February. At that meeting, the FDA made it clear that the 50-patient extension was not enough for an AA and that it needed to be at least doubled in size. Until then, LM was probably assuring HR that the extension was big enough for an AA, despite the reservations expressed by an analyst during the 2Q call and (probably) by the potential 102 pharma partner(s) a few months later. The FDA meeting confirmed that LM was incompetent, at least with respect to clinical trial requirements, and so she had to go.
The proof is in the proxy filings. LM was the star exec of the 2010 proxy. She received almost as much total comp in 2009 as HR. (See 1st link below, starting at p. 32) In the 2011 proxy, released on April 29, her name has been completely expunged along with any mention of bonuses and option awards to her. (See 2d link, starting at p. 27) It's hard to believe that the 2009 star exec failed to qualify for any incentive comp during 2010. My guess is that it's been included in a severance package which took effect shortly after ASCO, which was LM's last appearance o/b/o NKTR (hidden away at the end of the panel table -- no MC role as at ASCO 2010).
So LM was still around for the unveiling of the PIII MBC trial details at ASCO, which she presumably helped to design. But why would HR or anyone else at NKTR trust her judgment at that point, after the extension fiasco? Maybe they decided it would be embarassing not to release any trial info at their ASCO event after promising to do so, but that would be a pathetic reason. Let's hope the FDA advised them at last month's post-PII MBC meeting to shelve the PIII and come back with a more rational PII controlled trial. I suppose we will find out next Thursday.
"I wonder if that is why Lorianne has diapppeared from the list of management."
If they announce next week that they've modified the previously articulated phase III plan in MBC, then I think you'll have the answer to your question. If, on the other other hand, they still appear hell-bent on going forward in phase 3 in MBC, then I am not sure what the logic would have been behind giving Masuoka the axe, since she appears to have been a driver of this phase 3 strategy.
Azn or any other big pharma partnering at this stasge of the game realizes the chance of 2 pIII and then fda approval is still a long shot. So, they take a gamble. If they get in early they get a better deal but increase their risk. They spread their money around to increase their chances.
Factor in that many blockbusters are going generic, that there are few blockbusters on the horizon, anf you find they take more even more risk. You really think they have the inside skinny?
How bout pfe and nktr, or dozens of other failed partnershops based on ok pII data that never panned out.
You really are a tool if you think azn's invovlement means you have a safe investment.
Didn' you learn with emis dum3q55
["It seems to me the BC data is sufficient to justify a further controlled PII trial, but it's ridiculous to begin an 840-patient PIII trial in MBC based on the results in a 16-patient subgroup of a single-arm PII study."
Completely agree. Some serious data mining was required to construct this phase 3 program. A 16-patient sub-sub-population? Come on, this is statistics 101]
Based on available info, HR has a 4 year degree in ACCOUNTING and no science education. He must be a good CON man to get to where he is with NKTR.
It is true that some large drug companies are run by people who have no science education. But most of them have competent scientists who help make drug development decisions. Apparently HR has surrounded himself with a bunch of bozos. I wonder if that is why Lorianne has diapppeared from the list of management.
"The reason this data mining was required is that the overall survival data simply did not pan out as well as everyone (including the partner with whom the deal had been "anticipated") hoped tht it would"
And Multi says the 60% is ALL due to the cash flow problem LOL! What a dumb***! Typical!!!
Hope this helps ;)