FDA accepts NDA for Lundbeck and Otsuka's aripiprazole depot formulation

Danish CNS drug specialist Lundbeck (LUND: DC)  and its new partner Japan’s  Otsuka Pharmaceutical (TYO: 4768).revealed yesterday that the US Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

Just earlier this month Otsuka and Lundbeck entered into a long-term CNS agreement for up to five innovative psychiatric and neuroscience products, which could earn the Japanese firm as much as $1.8 billion (The Pharma Letter November 11). The two companies are collaborating on the co-development and co-commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

Aripiprazole is already marketed as Abilify for schizophrenia, bipolar disorder and depression by Otsuka and US drug major Bristol-Myers Squibb, but the original formulation is due to lose patent protection. Abilify generated sales of $4.5 billion in the 2010 financial year and is a big profit driver for Otsuka.