AstraZeneca pulls depression drug, takes $50m hit
pharmafile | March 20, 2012 | News story | Research and Development, Sales and Marketing | AstraZeneca, R&D, depression, failure, pipeline
AstraZeneca and partner Targacept will not file their depression drug TC-5214 for regulatory review.
The decision comes after disappointing Phase III results for the drug, which did not meet the primary endpoints of improving depressive symptoms compared to placebo.
AZ was developing TC-5214 in conjunction with North Carolina, US-based Targacept, after both firms signed a collaborative deal in December 2009.
The firms were testing the drug in several Phase III studies as an add-on therapy to an antidepressant in patients with major depressive disorder (MDD), who did not respond to initial antidepressant treatment.
The first two studies: RENAISSANCE 4 and RENAISSANCE 5, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of add-on treatment with TC-5214, compared to placebo.
RENAISSANCE 7, a long-term safety study, was generally well tolerated, with an adverse event profile consistent with prior clinical trials.
These three studies conclude the RENAISSANCE studies for the drug, but the failures of RENAISSANCE 4 and 5 has led to the drug being pulled from any regulatory review.
“Based on the totality of the results, AstraZeneca and Targacept will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD,” the firms confirmed today.
AstraZeneca will take a charge of $50 million for pulling the drug, which is the remaining value in relation to TC-5214.
The firms were expecting to file the drug in the US for the second half of 2012, with a European marketing authorisation application planned for 2015 – but this will now not go ahead.
Today’s decision was widely expected by analysts, after the drug failed in the RENAISSANCE flexible dose trial study in December.
AZ has already taken a $96.5 million pre-tax charge due to the earlier failure of the drug.
Failures
This marks yet another pipeline failure for AstraZeneca, that last year took a $382 million hit when it halted a Phase II study of olaparib in ovarian cancer due to poor results.
Its biologics arm MedImmune, which it paid $15.2 billion for in 2006, also pulled its main drug motavizumab for respiratory disease in infants in 2010, after the FDA said it was no better than existing treatments.
The firm is currently attending the Bio-Europe Spring conference to find new partners to help bolster its weakening pipeline.
Ben Adams
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