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FDA starts review of Lundbeck’s antipsychotic aripiprazole

Major milestone reached in CNS alliance between Danish pharma company and Otsuka

The US Food and Drug Administration (FDA) has started its review of a once-monthly depot formulation of the antipsychotic drug aripiprazole, marking a major milestone for the central nervous system (CNS) alliance between Lundbeck and Otsuka. 

The two companies entered into a multibillion collaboration in CNS drugs earlier this month, with depot aripiprazole the most advanced project covered under the agreement.

The two companies said in a statement that once-monthly aripiprazole has been filed for maintenance treatment of schizophrenia in adults, and that the FDA has confirmed the dossier is "sufficiently complete to permit a substantive review".

The filing is based on data from a phase III trial of the intramuscular formulation which was terminated early after an independent data monitoring committee concluded that it had met its criteria for efficacy. A marketing application in Europe is not expected until 2013.

Otsuka originally developed aripiprazole and sells a once-daily tablet formulation under the Abilify brand name in collaboration with Bristol-Myers Squibb (BMS).

Otsuka estimates that Abilify will achieve sales of 397 billion yen ($5.1bn) this year, with the bulk (almost 80 per cent) of turnover coming from the US market, although sales growth has started to slow down in the face of generic competition for older antipsychotics. This slow-down is expected to continue following the loss of patent protection on Eli Lilly's big-selling Zyprexa (olanzapine) brand earlier this year in the US.

Many of the companies with established brands in the schizophrenia market have elected to develop depot formulations, in part to insulate their brands against generic competition but also to provide an additional option for schizophrenia patients who find it difficult to comply with more frequent dosing regimens.

The new aripiprazole formulation will compete with Janssen's once-monthly Xeplion (paliperidone) product, which was approved in Europe for schizophrenia in September and sold in the US as Invega Sustenna, as well as the firm's older depot Risperdal Consta (risperidone). Novartis and Vanda Pharmaceuticals also have a depot formulation of iloperidone in trials which should reach the market in 2015.

A recent report from market research company Decision Resources estimated that the market for depot antipsychotic formulations will nearly double to reach $1.6bn in 2020, with aripiprazole grabbing the greatest market share with sales of $650m in that year.

The new depot formulations will offset sales lost to the generic erosion of Risperdal Consta, which loses patent protection in 2014.

Otsuka is also developing a once-weekly oral formulation of aripiprazole which recently started phase III trials as a treatment for Tourette's syndrome in the US.

22nd November 2011

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