Lundbeck, Otsuka scramble to get antipsychotic back on FDA track

Lundbeck and its partner Otsuka have put their bid for an approval of their long-acting version of the antipsychotic drug Abilify back on the regulatory track. The partners on aripiprazole say that the FDA has accepted their resubmission for the treatment and set a PDUFA deadline for the end of February in 2013.

The partners were thrown off schedule back in July when the FDA rejected their application for the schizophrenia treatment, citing problems with a third-party supplier of sterile water used in the production of the drug. Analysts generally accepted the news as a temporary setback for the development team, which has been racing ahead as Alkermes ($ALKS) pushes ahead on its own late-stage trial for ALK 9070, a competing version of once-monthly Abilify. 

Provided Lundbeck and Otsuka go on to an approval, they'll be able to start marketing a few months before Alkermes expects conclusive Phase III data, with a potential approval in the schedule for 2014. But that hasn't blunted enthusiasm for Alkermes prospects, with some peak sales forecasts hitting $500 million.

"In the longer term, we believe that Otsuka and Lundbeck's presence would benefit Alkermes by expanding the long-acting market in the U.S. (currently, long-acting formulations account for only about 5% of the domestic atypical antipsychotics market) and creating interest in the aripiprazole depot formulations," Cowen analysts noted earlier.   

Like a lot of pharma companies, Lundbeck has been struggling to advance new products to counter the effects of an aging product portfolio. A few weeks ago it touted its Alzheimer's program for AE58054, which is headed into late-stage studies. In the wake of the failure of the Phase III programs for bapineuzumab and solanezumab Lundbeck feels it has a shot at gaining the lead position in Alzheimer's R&D, which has attracted attention from potential development partners.

- here's the release