Lundbeck and Takeda to file for Lu AA21004 approval in USA and Europe on strong Ph III results

15 May 2012

Danish CNS drug specialist Lundbeck A/S (LUND: DC) yesterday 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 10mg to 20mg.

Based on the current data, Lundbeck and its partner, Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502) plan to submit a New Drug Application to the US Food and Drug Administration during the second half of 2012. Separately, Lundbeck plans to submit a Marketing Authorization Application to the European Medicines Agency, as well as Health Canada, for Lu AA21004 during the second half of this year.

The news pushed Lundbeck’s shares 8.8% higher to 118.6 Danish kroner and analyst at Credit Suisse said that they have a net present value of Lu AA21004 to the company of 9.19 a share (some 5% of the total).

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