Deal to develop TC-5214 is terminated after phase III trials fail to prove drug's efficacy
AstraZeneca has pulled out of a research collaboration with Targacept to develop its investigational antidepressant TC-5214 after the drug failed to live up to expectations in late-stage trials.
AZ will pay impairment charges of $50m to exit the deal for TC-5214, which was being developed as an adjunct treatment for patients with major depressive disorder (MDD), and all regulatory plans for the product have been halted.
The pharma firm dropped the drug after two phase III studies failed to reach their primary endpoint of change of a patient's score on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of adjunct treatment compared to placebo.
The decision brings an end to the collaboration AstraZeneca and Targacept struck in 2009 when the Anglo-Swedish pharma firm acquired rights to the drug for an upfront payment of $200m, with over a $1bn available to Targacept in additional payments.
Despite initial high hopes for the drug, which is designed to calm neuronal nicotine receptors (NNRs) in the brain, its development has failed to match expectations.
Data released in November from previous phase III trials also demonstrated a lack of efficacy in the drug, although at the time AstraZeneca said it was committed to filing the drug for approval as a treatment for patients who have an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin/norepinephrine reuptake inhibitor (SNRI).
AZ's latest announcement comes one year after GlaxoSmithKline (GSK) ended its research partnership with US biopharmaceutical company Targacept.
The GSK collaboration, which aimed to develop medicines in a variety of therapy areas that targeted NNRs, was terminated due to “significant strategic changes in the neurosciences area”, according to GSK.
That deal was worth up to $1.5bn for Targacept if milestones were met in developing products for pain, smoking cessation, addiction, obesity and Parkinson's disease.