Posted by douxmari on April 10, 2006, at 13:34:08
In reply to Re: agomelatine (Valdoxan) - Application to FDA? » SLS, posted by jrbecker on April 5, 2005, at 21:46:19
Novartis and Servier announced today the signing of a licensing agreement for agomelatine, a Phase III investigational drug for the treatment of major depressive disorder, a condition estimated to affect one in ten adults in the US alone.
Under development as a once-daily treatment, agomelatine is a novel melatonergic antidepressant that acts as an agonist at MT1 and MT2 receptors with additional 5-HT2c antagonist properties. Due to its unique receptor profile, agomelatine represents a potential innovation for the pharmacological treatment of depression.
Under the terms of the agreement, which requires antitrust approval in the United States, Novartis has acquired the exclusive rights to further develop and market agomelatine in the US and several other countries. Servier retained the rights to develop and market the product in the rest of the world. Financial terms of this agreement were not disclosed.
"This collaboration shows our commitment to invest in promising and innovative compounds like agomelatine to further strengthen our portfolio," said James Shannon, Head of Development, Novartis Pharma AG. "With the initiation of a clinical development program for agomelatine in the US, Novartis will be able to build on its leadership position in neurology and potentially become a key player in the field of psychiatric disorders such as depression."
do you think they can get a quick approval in the US? And how soon can they submit to FDA?
poster:douxmari
thread:479920
URL: http://www.dr-bob.org/babble/20060408/msgs/631406.html