Targacept falls as TC-5214 plans shelved

Targacept Inc. (NASDAQ:TRGT) fell $2.22 (30%) to $5.19 on Tuesday after it and AstraZeneca plc (LSE:AZN; NYSE:AZN) abandoned plans to submit regulatory applications for TC-5214 as an adjunct treatment for major depressive disorder. The decision follows data showing TC-5214 missed the primary endpoint vs. placebo in both of the fixed-dose Phase III RENAISSANCE 4 and 5 trials -- the remaining two efficacy trials in the five-trial RENAISSANCE program. The partners previously reported that TC-5214 missed the primary endpoint vs. placebo in both of the flexible-dose Phase III RENAISSANCE 2 and 3 trials. The program's last trial -- the RENAISSANCE 7 safety trial -- showed that TC-5214 as an adjunct therapy was well tolerated. Each efficacy trial evaluated a primary endpoint of the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at week eight. The partners had planned to submit an NDA to FDA for TC-5214 next half, while an MAA submission to EMA was expected in 2015.

AstraZeneca said it will record an intangible asset impairment charge of $50 million based on the decision. At Dec. 31, 2011, Targacept had $249.3 million in cash and a 12-month operating loss of $9.7 million. TC-5214 is an S-enantiomer of mecamylamine hydrochloride, a broad spectrum non-competitive nicotinic receptor antagonist. ...