Lu AA 21004 successful Phase III trials in Depression

Lundbeck announced positive top-line results from three recently completed phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10 to 20mg. The positive results from these three studies showed that Lu AA21004 statistically significantly reduced depression symptoms in patients with MDD compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Further analysis of the data is ongoing and data are expected to be presented at upcoming medical conferences. Lundbeck and its partner Takeda plan to submit a New Drug Application to the FDA during the second half of 2012. Separately, Lundbeck plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and to Health Canada for Lu AA21004 during the second half of this year.