Psychosis in its early phases sometimes is under diagnosed and people don't come into treatment until it starts to cause marked distress in the person or family members
I believe it is bigger than people think. This is under diagnosed especially in the early stages and we wow that untreated psychosis doesn't magically get better. If continues to be safe, Pima will be used earlier and earlier as physicians gain comfort with it. Also did you know that Lewy Body dementia which is very similar to PD is a similarly sized market? I think the black box warning of increased mortality on all atypical antipsychotics in the elderly will one day make Pima the antipsychotic of first choice in the elderly. So they are starting with the low hanging fruit and then expanding out
Good question. Not sure regarding timing. I would bet that the old regime was trying to be conservative. You have an FDA breakthrough status. What question would the FDA need help with? The data are very straightforward. I just don't see the need.
I will say we have good medications for bipolar depression. Lamotrigine which is generic and use widely off label. I hope they have good data but I want to see the design of those studies. And see what medications they use as comparators
I have a massive position in acad and a normal position in ITCI. I believe both medications will be used widely for different purposes. And even in markets where they may compete, there is big enough room for both. ITI-007 already has one positive phase III trial versus placebo and has a second Phase III vs Risperdal 4 mg that should have results mid-2016. The first indication they are pursuing is schizophrenia. Unlike pimavanserin, ITI-007 modulates D2 receptors (less at lower doses of 1-10 mg and much more at higher doses 60 mg). The dopamine impact of ITI-007 means that they aren't going after PDP any time soon. Too risky.
Now they are pursuing an agitation is adp indication but I think if there is any safety signal in the elderly, then it will get painted with the atypical brush and FDA black box warning of increased mortality in the elderly. And in comes pimavanserin which if it continues to look clean and with a non-dopamine should avoid the FDA black box.
That said, I like both medications a lot and don't see them as direct competitors
I think a good proxy is pharmacyclic's ibrutnitb in terms of unmet need. There was no FDA advisory panel and it was approved early, IRRC. Anyway that is what I'm expectation with pimavanserin
Seriously Seldane? That was 1990! And an allergy pill. Very different situation.
What Adcom? There may not be an Advisory Panel for pimavanserin.
Wrong. Cowen reiterated. Leerink reiterated and raised their target. Only piper downgraded and he fumbled this one I think
Also the agitation market dwarf the psychosis market.
I do agree with your comment on the delay of ADP. And buyout. BB need a way to get liquid. It's a top 3 holding for them. Most of their other top holdings are sold... Pcyc, geva... It just makes too much sense. Someone will plunk down $60-70 a share and Davis and the board is going to take it.
I'm a psychiatrist and adamantly disagree with your QT prolongation comment. All antipsychotics prolong the QT. Many much more than the modest amount pimavanserin showed in its studies. This is a non issue.
Yes - I have always believed that they have been dragging their feet on the adp study so they don't mess up the nda filing for PDP. Anyone who has followed the drug industry knows that first you get approval and THEN you go after other indications. It just isn't worst the risk of casting doubt on the PDP studies shoal some signal emerge in the ADP data. So for me, I'm happy to wait on those results.
I don't think its started yet. And there is the GVH issue that could occur if using another person's T-cells. I think CLLS will have to show data that this isn't an issue. Probably the next study will help guide us.
Thanks. Interesting to see if this works and also supresses T-cell alloreactivity. If it can avoid GVH then will be huge. I need to see data before I believe that they can do this but definitely interesting.
Yeah so I checked and it's not. Do you know why? Because only time will tell if GVH is an issue. But if it isn't your own T-cells then it is a real and potentially life threatening risk until proven otherwise.