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Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder
Lundbeck HQ

Otsuka and Lundbeck have filed for approval of brexpiprazole - their follow-up to blockbuster antipsychotic Abilify - in the US.

Like Abilify (aripiprazole), brexpiprazole (formerly OPC-34712) has been developed for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder (MDD) but has a slightly different mechanism of action that - at least in theory - could mean it has an improved clinical profile.

Abilify has already lost patent protection in a number of markets around the world and is also facing generic competition in its last major bastion of the US from April next year.

A long-acting follow-up called Abilify Maintena reached the market last year, which helped defend the franchise from generic competition. Overall, sales of Abilify fell 3 per cent in 2013 but still topped $8bn, making the drug the fifth largest-selling pharmaceutical product in the world.

Sales are expected to fall off dramatically in the coming years, with Abilify Maintena and brexpiprazole both playing their part in helping to limit the impact.

Analyst estimates for peak Abilify Maintena sales range from $500m to $1bn, while some predict brexpiprazole could add another $1bn to that tally, but only if Otsuka and Lundbeck can convince doctors its profile is clinically superior to Abilify and generic aripiprazole.

The new drug exhibits reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors compared to its parent compound, which should improve its tolerability. In clinical trials, it seemed to have fewer side effects such as akathisia (restlessness) but did appear to cause a little more weight gain.

Meanwhile, Otsuka and Lundbeck could face competition from Alkermes, which is developing its own long-acting antipsychotic aripiprazole lauroxil, which has shown promising activity in phase III trials and has also been tipped as a $1bn drug.

Brexipiprazole is one of a trio of new drugs Lundbeck and alliance partner Otsuka are relying on to drive growth in the coming years, alongside recently launched antidepressant Brintellix (vortioxetine) and alcohol dependence therapy Selincro (nalmefene).

A fourth Lundbeck candidate, desmoteplase for ischaemic stroke, experienced a setback after a phase III trial reported last month indicated it lacked efficacy, while the partners recently started late-stage testing of Alzheimer's disease candidate Lu AE58054.

Article by
Phil Taylor

15th July 2014

From: Research, Sales

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