AstraZeneca - TC-5214 reported negative Topline Data from EU study; while outcome from other studies still awaited
AZN and Targacept today announced top line data of TC-5214 from European PhIII study (RENAISSANCE 3) which did not meet primary efficacy end point of change in MADRS score when added to placebo (citalopram). On safety front, reported adverse events were similar to what it was observed in PhIIb trial (Constipation, Asthenia). A negative outcome in PhIII EU studies (Chart 1- Geography wise market size MDD, EU – 22%) comes as a blow for Targacept/AstraZeneca, as it was not expected based on the PhII studies. The PhII studies enrolled only patients from India and US and hence we continue to be hopeful on the outcome from other ongoing PhIII studies (Table 1), which are being carried out in the Indian and US population. Even if the PhIII data from other studies emerges positive, we do not see major market potential for adjuvant treatments in the depression market, as our discussion with KOL suggests, switch therapy is more preferable when patient do not respond to first line antidepressive agent rather than going for adjuvant therapy.
COMPANIES MENTIONED
AstraZeneca
AstraZeneca
