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FazaClo

Jazz Pharmaceuticals plc

Drug Names(s): orally-disintegrating clozapine, Versacloz (oral suspension)

Description: FazaClo is an orally-disintegrating formulation of clozapine that uses OraSolv technology, which makes the tablet rapidly disintegrate in about 15 to 30 seconds and is then swallowed reflexively in saliva. Clozapine is an atypical antipsychotic drug in that it has a relatively low affinity for the dopamine D-2 receptor and high affinity for the serotonin 5-HT2 receptor, which produces a high 5-HT2/D-2 ratio. Though the exact mechanism is unclear (either due to a difference in affinities for such receptors or fast dissociation from the D-2 receptor), atypical antipsychotics are able to produce an antipsychotic effect (through blockade of D-2 receptors in the ventral striatum) with fewer extrapyramidal motor function side effects (or EPSs, which are caused by blockade of D-2 receptors in the dorsal striatum).

Deal Structure: FazaClo uses OraSolv technology licensed from CIMA LABS. CIMA LABS is a subsidiary of Cephalon.

Avanir and Alamo
Avanir Pharmaceuticals announced in May 2006 that it entered into a definitive agreement with the shareholders of Alamo Pharmaceuticals to purchase the Company, which includes the acquisition of FazaClo. The upfront acquisition cost of approximately $29 million (excluding transaction costs), consisted of approximately $4 million in cash and approximately $25 million in notes. Avanir will be required to pay up to an additional $40 million for milestone payments.

Azur and Avanir
Avanir announced in July 2007 that it signed a definitive agreement to sell its FazaClo to Azur Pharma. Under terms of the agreement, Avanir will receive approximately $42 million at the close of the transaction with up to an additional $10 million in contingent payments in 2009. In addition, Avanir will receive up to $2 million in royalties, based on 3% of annual net product...See full deal structure in Biomedtracker

Partners: Otsuka Holdings Co., Ltd. Teva Pharmaceutical Industries Ltd.


FazaClo News


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