The clinical Phase III program will consist of several clinical studies that will be conducted at investigational sites around the world. Based on the positive clinical phase II data, the first patient in a Phase III study in major depressive disorder has been enrolled. More than 2,000 patients are expected to be enrolled in the clinical phase III program.
Lu AA21004, discovered by Lundbeck and being jointly developed by Lundbeck and Takeda, belongs to a new chemical class, which has a mode of action that is different from currently marketed antidepressants. In the clinical Phase II study, Lu AA21004 showed highly significant improvements on the primary efficacy endpoints for both 5 and 10mg doses compared to placebo and had an attractive safety profile.
Lundbeck will receive a milestone payment from Takeda of $40 million in connection with the advancement of Lu AA21004 into clinical Phase III. The payment will be booked by Lundbeck as other revenue in the fourth quarter of 2007.
Masaomi Miyamoto, general manager of the pharmaceutical development division of Takeda, said: “Advancing this compound for the treatment of mood and anxiety disorders to Phase III represents a significant achievement in Takeda’s enhancement of our R&D pipeline in the central nervous system field.”