AZ licences late-stage depression candidate
pharmafile | December 8, 2009 | News story | Sales and Marketing |Â Â AZ, Targacept, depressionÂ
AstraZeneca is to pay $200 million up front for rights to a late-stage developmental drug aimed at sufferers from depression who do not respond adequately to first-line treatment.
Targacept’s TC-5214 recently completed a phase IIb clinical trial for the treatment of major depressive disorder (MDD), which affects around 42 million people worldwide.
The nicotinic channel blocker is thought to treat depression by modulating the activity of various neuronal nicotinic receptor (NNR) subtypes.
Serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed class of drugs for depression, but the companies point out that the NIMH STAR*D study suggested 63% of patients do not achieve remission with SSRI treatment.
Targacept chief executive J. Donald deBethizy described TC-5214 as bringing “a new mechanistic approach ¿ to the millions of patients who do not respond well to first-line antidepressant therapy and need relief”.
“The opportunity to improve treatment in depression is a large one, both commercially and in terms of benefits for patients,” added AstraZeneca chief executive David Brennan.
TC-5214 will not be filed before 2012, but if approved the drug would enter a global antidepressant market valued at more than $20 billion.
If it is then successful, Targacept could receive another $540 million from AstraZeneca based on specific development, regulatory and sales milestones.
Targacept is also in line to get up to $500 million based on sales as well as double-digit royalties on net sales worldwide.
The company has retained the option to co-promote TC-5214 to a small audience of US physicians.
AstraZeneca and Targacept will put together a global phase III clinical programme which should begin in the middle of next year.
A new drug application will be filed with the US Food and Drug Administration two years later if all goes to plan.
There will also be a phase II study with TC-5214 as a monotherapy for MDD.
Cost of the initial global development programme will be split 80-20 between AstraZeneca and Targacept.
The companies already have other drugs in clinical development for cognitive disorders following a deal signed four years ago.
They are AZD3480 for attention deficit/hyperactivity disorder, AZD1446 for Alzheimer’s disease and TC-5619 for cognitive dysfunction in schizophrenia.
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