Grupo Ferrer will make an up-front payment of $10 million to Alexza Pharmaceuticals in return for rights to co-develop the latter’s registration-ready inhaled Adasuve™ (AZ-004) treatment for agitation in patients with schizophrenia or bipolar disease. Under terms of the deal Ferrer will partner Alexza in the registration, distribution, and promotion of Adasuve in Europe, Latin America, Russia, and the Commonwealth of Independent States countries.
Alexza says it plans to file for approval of Adasuve in Europe before the end of 2011. The firm resubmitted an NDA for AZ-004 to FDA in August, which it says addresses issues detailed by the agency in a complete response letter issued to Alexza in October 2010.
Adasuve is a loxapine-based therapy administered using Alexza’s handheld single-dose inhaler system, Staccato, which is designed to deliver the aerosolized drug to the deep lung, resulting in IV-like pharmacokinetics and providing rapid systemic effects.
Under terms of the new deal with Ferrer, Alexza will retain responsibility for filing the Adasuve MAA with the European Medicines Agency, but Ferrer will be responsible for all subsequent regulatory filings in its designated territories, along with required pricing and reimbursement filings and approvals. The Spanish firm will then exclusively distribute, market, and sell Adasuve in the relevant country. Alexza will be eligible for additional regulatory and commercial milestones and will exclusively supply Adasuve to Ferrer for commercial sales.