zicronapine (Lu31-130) / Lundbeck - LARVOL DELTA

Distal kinetic deuterium isotope effect: Phenyl ring deuteration attenuates N-demethylation of Lu AF35700. (PubMed, Bioorg Med Chem Lett) - "The N-demethylation of zicronapine (7) and three of its deuterated analogs 8 - 10 has been studied in human in vitro metabolism systems. Additional deuteration of the N-methyl group, which as mentioned had shown no effect in isolation, further decreased the rate of the N-demethylation reaction (compound 10vs.9). This paper presents and discusses this unprecedented 'distal kinetic isotope effect' that was observed when incubating the test compounds with human liver microsomes or recombinant human CYP450 liver enzymes."

Journal

Investor & Analyst Presentation: Lundbeck (Lundbeck) - Anticipated submission of MAA in Europe is on track and expected around Q4 2012 and anticipated approval US/EU is expected in 2013 for Aripiprazole depot; Anticipated NDA submission for OPC-34712 is expected in 2014; Anticipated submission of MAA and approval of OPC-34712 in US is expected in 2015; Expected enrollment for zicronapine is 160 patients; Lundbeck launched Sycrest in Japan for schizophrenia

Anticipated EU regulatory • Anticipated FDA event • Enrollment status • Launch non-US • Schizophrenia

Q2 2012 Results (Lundbeck) - Anticipated launch in 10-15 additional countries for schizophrenia in H2 2012; P3 program is ongoing for zicronapine focusing on schizophrenia will enroll around 160 patients and company is planning to include additional P3 studies which will investigate benefit and risk profile

Anticipated launch • Clinical protocol • Schizophrenia