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news.Grupo Ferrer International has entered into an agreement for the commercialization of Alexza Pharmaceuticals' Adasuve (Staccato loxapine) to treat agitation in patients with schizophrenia or bipolar disorder in Europe and Latin America.
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Adasuve is an anti-agitation therapeutic which combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic drug.
The Staccato system is a hand-held, single-dose inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and rapid systemic effects.
Alexza will receive an upfront payment of $10m, as per the agreement and is eligible to receive additional milestone payments based upon regulatory approvals, individual country commercial sales initiation and cumulative net sales targets.
Alexza plans to file the Adasuve Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
Grupo Ferrer will be responsible for all subsequent regulatory filings in the countries in its territories, as well as any required pricing and reimbursement filings and approvals.