They definitely do. They can afford to nibble here and there and then move in for the big bite once they have the confirmatory data they're looking for. They nibble on lots of small companies but it's small dollars at the end of the day. Acadia has become one of their true crown jewels. Meanwhile, Lundbeck said today that they will launch a new Alzheimer's drug by 2017. They're working on a serotonin 5HT6 blocker. The interesting thing is that blocking 5HT6 is not going to change the course of Alzheimer's. The bottom line is that these patients are facing a terrible battle including nursing homes. Pimavanserin is the right drug at this time because it's going to ease the suffering of patients and families until a breakthrough is found that can actually change the course of disease. At this moment I don't know of anything on the horizon. Pimavanserin is all about easing suffering for patients and caregivers. I can't think of a more important drug for these individuals suffering so much. It was hoped that Targacept's drug would work in schizophrenia and then it would be tried in Alzheimer's. It didn't work at all. It falls into the pile of failed drugs for cognitive disorders...the huge and growing pile. Pimavanserin is in a league of its own IMO.
Good post as usual. I think this issue of loss of sensitivity to the impact of a7 agonists may be what we're seeing. Perhaps the drug works for a week and then just stops. It's that or the target just doesn't work. I don't think it's just this candidate since Memory Pharma also bombed (with a different candidate but somewhat similar target - still a7). Some a7 candidates also impact 5HT3 but there is ample data to suggest that 5HT3 is not the reason cognitive enhancement is seen. Anyway, this one is clearly a no-go.
I'm with you regarding the impact outside of the CNS. We may see some tax loss selling but I don't think there will be much unless a large fund unloads. I will be a buyer if we start to trade at a discount to cash. I'm not sure I've seen enough data on the pipeline to be excited yet. I think data for urinary incontinence is mid-year so we have a wait. I wonder how much they will burn.
Also, I wonder if they will access the atm at this lower price??? I think they should add cash because $150M isn't that much at the end of the day.
It's actually so true. CNS is full of failures and that's what makes Acadia so special. Not only did they generate brilliant data, but the FDA waved off the second Phase 3. The bottom line is that Pimavanserin is a real drug...this is not some pie in the sky R&D outfit . I've been adding once again as my opinion is that 2014 is going to be a great year for Acadia.
Targacept ran a well planned clinical trial with a solid candidate, a solid theory regarding method of action and the right patient population. They missed the primary and secondary endpoints. It's always sad to see a failure in CNS because it's an area that badly needs breakthroughs. Acadia has the potential to be the CNS company that finally brings a blockbuster to market. This isn't Merck, Pfizer or one of the giants. Acadia was a tiny company not all that long ago. Their success will bring a lot of money to the entire CNS sector as investors will start to realize that the right company and right candidate can get it done. All my opinion, but Acadia is succeeded where countless others have failed.
I agree with you. Also, 2014 will see the filing of the NDA and that's a milestone that will get the analysts excited. Off-label prescribing and label expansion are highly likely once approved so I personally believe that 2014 is going to be a great year for Acadia. I've been adding to my holding this month. I wouldn't mind one more opportunity around $20 but I don't think it's coming. For that reason I bit the bullet and started buying at current levels.
I don't know how long this will take, but I don't see any need for a Phase 3 trial after the Phase 2. My own take would be that they would use the Phase 2 data to start off-label prescribing (which might be brisk) and then use an open-label Phase 4 for the label expansion. Of course, it's all apples to oranges at this point. I can only go on what Acadia is saying. Label expansion is certainly how I would play it as it's the lowest risk and fastest pathway IMO. You don't have to wait for an NDA to start generating revenue. This is how I see it anyway.
It's very difficult for Acadia to give a definite timeline, but the bottom line is that quality clinical trials take time and Acadia is clearly indicating that they're penciling in two years. If that's what they're putting on record then that is what I'm following. My attention is much more focused on the timing of the NDA filing which I'm hoping can be bumped up. However, the FDA would have to be flexible and we don't know if that will happen.
I continue to look for a mid to late M&A event. All my opinion of course, but that's how I'm seeing this.
That's actually a great point and the primary reason I'm nibbling. I did sell some shares at $25 and I wanted to reload on some of those. Uli sounded really polished in the last two calls. I'm looking for M&A by June 2014, but it could easily come before then. This is of course just my opinion...others may want them to get closer to the NDA or even go it alone. I just think the virtual model is so clean that this is set for M&A.
I didn't hear anything that was very clear. I'm looking forward to additional clarification from Acadia. Regardless, they're going to get off-label prescribing for ADP anyway. They may even be able to bypass a Phase 3 and use a Phase 4 strategy if the Phase 2 results are good enough. I'm never in a rush to enter a Phase 3...once a drug is approved there are so many better ways to expand the label. I'm not seeing a Phase 3 here...maybe an open-label Phase 4 but not a Phase 3. All my opinion and we clearly need more information from Acadia.
See you're hearing the same way that I heard it. Tom Aasen earlier gave a similar timeline for a Phase 2 (though I don't remember when/where). I agree with your assessment and personally think we're talking 2 years for the Phase 2. Screening the patients (to make sure you have the perfect patients) takes time. I definitely cannot imagine carrying out a Phase 2 and 3 within two years. Especially because a Phase 2 is typically going to be multicenter.
Anyway, I don't mind them taking a lot of time for the Phase 2. I actually prefer it. I don't like rushed data in CNS....too many past examples of stumbles. Acadia has a formula that works and they should follow it again and again.
I'm confident that it's 2 years for the Phase 2, but perhaps IR can shed some light on this for those that want a much quicker timeline. I'm not sure I see the benefit to quicker data though. I know it's earlier revenue, but it's also much more risk. There is no such thing as a layup in biotech/pharma. The last guy I heard say that bet the education funds of his child and lost it all! Slow and steady for me. I'm way up on this and am holding more than enough. I really love Acadia...just like it slow and steady.
It's a bit hard to tell exactly what the timing is just now. I'm really looking forward to hearing some concrete timelines once this trial is up and running. Patient selection has been the time limiting factor in the past, but that might improve this time because there is a patient pool on premises that is well known/characterized. I'm really interested in the Phase 3 design because I'm assuming it will have to be multi-center.
Interesting that Uli referred to the company as 'virtual'. This is a really easy asset to buy for large pharma. I may be in the minority but I personally can see M&A before June of 2014.
Thanks for that post. I feel exactly the same way. I don't know why Neurocrine even bothered with the update as there really wasn't an update. I basically learned that there will be no news for a good while. I'm not sure how I feel about the additional dose in the UF trial. Like you say, Abbvie has screwed around a bit. Didn't they even through an estrogen blocker or agonist into the mix at some point? I can't recall.
Anyway, I decided to exit for now and will look to enter if we hit that $7 mark you mentioned. I'm not happy with what I heard yesterday...it was confusing to say the least.
Thanks. Did you get part of that Gilead buyout? I actually just played CTIC based on their JAK (that Baxter just in-licensed). I really loved the YM candidate and have been trying to track its progress via Gilead but the big boys don't need to disclose much. Anyway, thank you so much. What is your take on ACAD? Would love to hear.
I am finally seeing this message. I have been out of touch for a good while but I am still long and strong. Haha...."the meaty topics" are for all to share and I really hope that you decide to share that beer!