AZ, Targacept in Depression Pact

AstraZeneca and Targacept have entered a collaboration and license agreement for the global development and commercialization of TC-5214, Targacept’s late-stage investigational product for major depressive disorder (MDD). TC-5214, which recently completed a phase IIb clinical trial, is a nicotinic channel blocker that is thought to treat depression by modulating the activity of various neuronal nicotinic receptor (NNR) subtypes.

AZ will make an upfront payment to Targacept of $200 million upon effectiveness and as much as $540 million more if specified development, regulatory and first commercial sale milestones are achieved. Targacept will also be eligible to receive as much as $500 million if specified sales related milestones are achieved, in addition to stepped double-digit royalties on net sales worldwide. Targacept has retained an option for a co-promotion of TC-5214 to a limited target physician audience in the U.S.

The companies will jointly design a global phase III clinical program anticipated to begin in mid-2010 with the goal of filing an NDA with the FDA in 2012. TC-5214 is being developed as an adjunct to antidepressant therapy in adults with MDD who do not respond adequately to first-line antidepressant treatment. The companies will also initiate a Phase II study exploring TC-5214 as a monotherapy for MDD. AZ will be responsible for 80% of the cost of the initial global development program and will be responsible for and will fund the costs of global commercialization of TC-5214, assuming Targacept’s manufacturing and supply agreements with third parties in relation to TC-5214. The agreement also provides for a specified period for the parties to negotiate a potential multi-year research program that would be conducted by Targacept to identify and develop additional NNR Therapeutics for MDD and possibly other indications.

David Brennan, AZ’s chief executive officer, said, “The opportunity to improve treatment in depression is a large one, both commercially and in terms of benefits for patients. It’s an area both AstraZeneca and Targacept know well and I’m pleased to be adding another late stage project to our pipeline.”

The companies previously entered into a global collaboration focused on cognitive disorders in 2005. Three product candidates from that collaboration are currently in clinical development: AZD3480 for ADHD, AZD1446 (Alzheimer’s disease), and TC-5619, for cognitive dysfunction in schizophrenia.