Phase III trials scheduled to start in 2010, as companies continue clinical development of another three drugs.
AstraZeneca negotiated a deal with $200 million up front for global development of Targacept’s major depressive disorder (MDD) therapy, TC-5214. The drug is a nicotinic channel-blocker, which is expected to move into Phase III trials during mid-2010.
Targacept could earn another $540 million in development, regulatory, and first commercial sale milestones, $500 million in further sales-related milestones, plus double-digit sales royalties. The company has also retained an option to co-promote TC-5214 to a limited target physician audience in the U.S.
AstraZeneca and Targacept are separately negotiating a multiyear research program to be conducted by Targacept with a focus on additional neural nicotinic receptor candidates for MDD and potentially other disorders.
TC-5214 is initially in development as an adjunct to antidepressant therapy in adults with MDD who don’t respond adequately to first-line treatment. AstraZeneca and Targacept also plan to start a Phase II trial evaluating TC-5214 as a monotherapy for MDD. The companies will collaborate on design of the global Phase III program and project that if this is successful, an NDA submission for TC-5214 could be filed in 2012.
AstraZeneca will be responsible for 80% of development costs and will back all commercialization expenses. The company will also take over Targacept’s third-party manufacturing and supply agreements for the drug.
Targacept and AstraZeneca signed a separate global collaboration focused on therapies for cognitive disorders in 2005. Three candidates are currently undergoing clinical trials. AZD3480 (TC-1734) is a novel small molecule that acts selectively on the α4β2 NNR subtype. The drug has been evaluated in a number of Phase II trials and is being developed primarily as a treatment for attention deficit/hyperactivity disorder.
AZD1446 (TC-6683) is another small molecule that acts selectively on the α4β2 NNR subtype. AstraZeneca is progressing this candidate through Phase I as a treatment for Alzheimer. TC-5619 is a small molecule that modulates activity of α7 NNR subtype. The drug is currently in Phase I testing and will be developed to address cognitive dysfunction in schizophrenia as well as potentially other conditions characterized by cognitive impairment.