Mizuho report today - Settlement Not Precluded by Supreme Court Ruling,Catalyst Rich 6-12 Months - Pt 2
MS pain data the other major 2H catalyst. Expect top line before year end,
but not overall statistical significance given only ~50 patients/dose, looking
for evidence of dose response, safety/tolerability. We know higher doses
work from prior DPNP studies (45/30 and 30/30 vs. 20/10 approved). Phase
III plans next year with next gen AVP-786 would allow for higher drug
exposure with less quinidine if needed, dictated by Phase II findings. The
key is decision to move forward and efficacy signal. Alzheimer's Agitation
represents the home run indication in terms of size, with data broadly
expected in 1H14, with a narrowing of the timeframe in the coming months.
EU approval any day now, partner on the horizon. European approval is
normally ~60 days post positive CHMP decision, which was April 26. EU
partnership discussions are ongoing, but final terms may await Phase II pain/
agitation data concluding over next 6-12 months, as an ideal partner would
help fund global Phase III studies for future indications.
Speaking of catalysts, the agitation in autism study is slated to complete data collection this month. Best case, I'd think this means 2 months of data analysis before any results are announced. However, in addition to the end date this month, the clinicaltrials.gov site also notes that the study is still recruiting. Thus, one of those parameters must be wrong. If really recruiting it takes 44 weeks to complete the study on the last patient. If anyone speaks to Ian please ask if he knows if it's still recruiting.
This study is structured quite differently than the Alzheimer's agitation study and obviously in a very different population. If positive however, I'd expect a lot of new enthusiasm for the "home run indication".