AstraZeneca and Targacept initiate Ph III development of TC-5214 as adjunct treatment for major depressive disorder

Anglo-Swedish drug major AstraZeneca and US firm Targacept, have started enrollment of the first patient in the Phase III clinical development program for TC-5214, a nicotinic channel blocker, being developed by the two companies under a deal signed last year which could earn Targacept more than $1.24 billion (The Pharma Letter December 3, 2009).

The Phase III evaluation, referred to as the Renaissance Program, is designed to support the planned second half of 2012 filing of a New Drug Application with the US Food and Drug Administration for TC-5214 as an adjunct treatment for major depressive disorder (MDD) in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin/norephinephrine reuptake inhibitor (SNRI). A Marketing Authorization Application in Europe is projected for 2014.

Could enter $20 billion market