Resubmission of aripiprazole NDA accepted; AstraZeneca bond issue

Danish CNS-focused drugmaker Lundbeck (LUND: DC) and Japanese partner Otsuka Pharmaceutical (TYO: 4668) announced this morning that the US Food and Drug Administration has accepted for review the resubmission of the New Drug Application for aripiprazole depot formulation, a potential treatment for schizophrenia. The FDA stated that this resubmission constituted a complete class 2 response to its action letter of July 26, 2012. The Prescription Drug User Fee Act (PDUFA) goal date is February 28, 2013.

The NDA was resubmitted in response to a Complete Response Letter (CRL) Otsuka received from the FDA on July 26, 2012 which cited deficiencies from a recent inspection of a third party supplier.

Lundbeck has co-development and co-commercialization rights to aripiprazole depot formulation in North and Latin America as well as Europe, Australia and some other countries. Credit Suisse analysts put a net present value for aripiprazole in USA at 7.04 Danish kroner per share (4% of total) for Lundbeck and 112.5 yen/share (4% of total) for Otsuka. They comment that the PDUFA data is well ahead of their expectation of a third-quarter launch, so good news. Manufacturing problems generally take longer than expected so this should be taken well given the positive surprise, they said.