Replies to post #170275 on Biotech Values

[DewDiligence]

ACT reports positive phase-3 data in schizophrenia relapse:

http://finance.yahoo.com/news/richter-actavis-announce-positive-phase-070000889.html

There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses (24.8%) in the cariprazine group versus 47 relapses (47.5%) in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo (hazard ratio 0.45, 95% CI [0.28, 0.73] p=0.0010).

The FDA issued a CRL on this program in Nov 2013 (#msg-94290786) and asked for a new clinical trial, which is the one described above.

Cariprazine previously failed multiple phase-3 trials in such indications as MDD and bipolar disorder. Gedeon Richter, who originally partnered the Cariprazine program with FRX in 2004 (#msg-4636724), remains ACT’s partner on this program. Gedeon is 25% owned by the federal government of Hungary.