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Abilify Maintena

Otsuka Holdings Co., Ltd.

Drug Names(s): Abilify once-monthly (IM depot), Lu AF41155, OPC-14597

Description: BioMedTracker has separate drug profiles for the oral/intramuscular (IM) and IM depot formulations of aripiprazole. Please also see Abilify (Oral and IM).

Aripiprazole belongs to a new class of drugs called atypical antipsychotics, though it is different from other atypical agents because it is a partial agonist at the dopamine D-2 receptor, rather than an antagonist, and does not have a lower affinity there than at the serotonin 5-HT2A receptor. Its antipsychotic effect is thought to occur through blockade of D-2 receptors in the ventral striatum, and the partial agonism is though to reduce side effects of stronger D-2 blockade, especially motor function side effects caused by blockade of D-2 receptors in the dorsal striatum). By blocking overstimulated receptors and stimulating underactive ones, partial D2 agonists act as dopamine stabilizers.

Aripiprazole has high affinity for dopamine D2 and D3, serotonin 5-HT1A (partial agonist) and 5-HT2A receptors (antagonist), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors, and moderate affinity for the serotonin reuptake site. Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors.

Deal Structure: In November 2011, Otsuka and Lundbeck announced a development and commercialisation agreement for up to five products in the psychiatry field, including aripiprazole depot formulation and OPC-34712 from Otsuka and up to three highly innovative earlier stage projects from Lundbeck.

The alliance is a sales and cost share agreement. Otsuka will receive up to approximately USD 1.4 billion (approximately DKK 7.6 billion) in total from Lundbeck in upfront payment and development and regulatory milestone payments. Including sales milestones, Lundbeck will pay up to approximately USD 1.8 billion (approximately DKK 9.7 billion) to Otsuka. Both companies will share the sales as well as development and commercialisation costs based on the agreement.

In March 2013, Otsuka and Lundbeck announced an agreement to expand their existing collaboration to include promotion of Abilify in 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly...See full deal structure in Biomedtracker

Partners: H. Lundbeck A/S

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