Businessweek

H. Lundbeck A/S announced positive results from four pre-clinical animal studies with (vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other health agencies for the treatment of major depression. In these studies the objective was to further study the pharmacological profile of vortioxetine and the potential effects in models of depressive disorders assessing a variety of cognitive functions, including attention, memory and executive function. These studies were presented at the 2013 American Psychiatric Association Annual Meeting (APA) in San Francisco: Poster NR11-36: Modulation of GABAergic activity via 5-HT3 receptor antagonism is involved in vortioxetine's (Lu AA21004) in vivo pharmacodynamic profile. Poster NR11-58: Vortioxetine (Lu AA21004), an investigational multimodal antidepressant, reverses executive function deficits in rats treated subchronically with PCP. Poster NR11-59: Vortioxetine (Lu AA21004), an investigational multimodal antidepressant: Differentiation from currently used antidepressants in rodent models. Poster NR11-60: Vortioxetine improves a reversal learning deficit in rats induced by serotonin depletion with PCPA. Vortioxetine was demonstrated to modulate GABA-ergic activity in a cellular model, an effect of vortioxetine's multimodal activity. Vortioxetine also demonstrated improvement in attention, memory and executive function in animal models. The preclinical data presented at the conference also show a different profile of vortioxetine compared to fluoxetine and escitalopram (SSRIs) as well as duloxetine (an SNRI), which were not active in these animal models. While animal studies may not be directly applicable to human use, the new preclinical data provide supportive evidence that vortioxetine has the potential to improve cognitive symptoms frequently occurring in depressive disorder, such as impaired attention, memory and executive function. The preclinical data further suggest that the potential cognitive effects of vortioxetine in animals may be related to its activity at specific serotonin receptors. Unlike SSRIs or SNRIs, vortioxetine has a multimodal mode action that is thought to work through a combination of two complementary mechanisms of action: receptor activity modulation and reuptake inhibition. The multimodal action may translate into distinct clinical effects in the treatment of major depressive disorder (MDD), which is being investigated further in clinical studies.

Otsuka Holdings Co., Ltd. and H. Lundbeck A/S announced results from a preliminary analysis that showed statistically significant reductions (p<0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly ABILIFY MAINTENA(TM) (aripiprazole) - an extended-release injectable suspension formulation of aripiprazole - compared to previous treatment with daily standard-of-care (SOC) oral antipsychotics. Relapse, or an acute exacerbation of the disease, can result in hospitalization. It also has been reported that hospitalization may contribute to higher health care costs. These data were presented in a poster at the 166(th) American Psychiatric Association (APA) Annual Meeting in San Francisco on May 21. This multicenter, open-label, North American study used a mirror-image design to assess total psychiatric hospitalization rates - defined as proportion of patients with >=1 inpatient psychiatric hospitalizations. The study was divided into two treatment periods: the first was a retrospective, six-month period assessing total psychiatric hospitalization rates in stable adult patients with schizophrenia treated with oral SOC antipsychotics; the second treatment period included these same patients who were then converted to treatment with ABILIFY MAINTENA (aripiprazole) once-monthly 400 mg for six months in the following prospective phases:- Phase A (1-4 weeks): a conversion phase where patients cross-titrated from their current oral antipsychotic to oral aripiprazole; Phase B (24 weeks): an open-label treatment phase where patients received ABILIFY MAINTENA (400 mg with an option to decrease to 300 mg for tolerability). As part of the study design, patients also received concomitant oral aripiprazole for the first 14 days of Phase B and: Phase C: an ongoing extension phase.

Biotie announced that its partner H.Lundbeck A/S has launched Selincro in the United Kingdom. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone payment of EUR 2 million related to the UK launch. Biotie will potentially contribute to Lundbeck towards any required post approval commitment studies. Lundbeck will continue the rollout of Selincro in additional European markets through 2013 and into 2014.

H. Lundbeck A/S has announced that the company has shipped Selincro in its first markets and has made the product available for alcohol dependent patients with high-risk drinking levels in Norway, Finland, Poland and the Baltic countries. In clinical trials, Selincro reduced alcohol consumption by approximately 60% after six months treatment.

H. Lundbeck A/S, Q1 2013 Earnings Call, May 01, 2013