Highlights

But the advantage here is really to minimize the weight gain and they showed that patients on this [ALKS 3831] had perhaps 50% less weight gain compared to patients on only olanzapine. And, you know, they have a PDUFA date coming up in June I think, and they have a high probability of perhaps approval because the FDA response last time did not ask for additional clinical trials, which can delay things profoundly or significantly. They were asking mostly for clarifying manufacturing issues, which typically are easier to address. Just one thing, you know they said that the patients on [ALKS 3831] will gain 50% less weight than patients on olanzapine, well patients on olanzapine – some patients can put on up to 40 or 50 pounds in a very short amount of time, so 50% translates into 20 to 25 pounds. So, although it is 50% less than olanzapine, in terms of percentages, it’s still, in terms of numerically, 25 pounds, 20 to 25 pounds, which is substantial for a patient to put on. MIN-101, this is, you know I’m not sure if there’s much to talk about. This is the Minerva Neurosciences that has been tried for different indications. It failed for negative symptoms of schizophrenia and at this stage it’s not something that we are excited about. It’s on the back burner.

I don’t look at it as being a big player for negative symptoms. I’m not sure even if the trial will succeed because the drug first failed as monotherapy, and part of the scale that’s used does include a scale on the negative symptoms. So, I’m not sure if there will be any positive signals for pimavanserin in negative symptoms of schizophrenia. The real value of pimavanserin will be in dementia-related psychosis where they have more encouraging and supportive data, perhaps to encourage the FDA to give them this indication, which by far will be much bigger because there is a much greater unmet need for dementiarelated psychosis.