Alexza Pharmaceuticals Announces $1-Million Milestone Payment

Alexza Pharmaceuticals, Inc. recently announced that ADASUVE inhalation powder, predispensed (Staccato loxapine) is now available in Spain through Grupo Ferrer Internacional, S.A. (Ferrer). Ferrer is Alexza’s commercial partner for ADASUVE in the European Union (EU), Latin America, Russia, and the CIS countries. In conjunction with this commercial introduction of ADASUVE in Spain by Ferrer, Alexza will receive a milestone payment of $1 million.

“Given that Ferrer is one of the largest Spanish pharmaceutical companies, launching ADASUVE in our home market is an important milestone,” said Antoni Villaro, Chief Operating Officer of Ferrer. “We expect to demonstrate Ferrer’s commitment to commercial excellence and hope to serve as a reference for all other markets.”

“Ferrer has consistently demonstrated a high degree of focus, commitment, and collaboration in introducing ADASUVE to physicians who are seeking new therapeutic options for the treatment of agitation associated with bipolar disorder or schizophrenia,” added Thomas B. King, President and CEO of Alexza. “With the launch of ADASUVE in Spain, we are pleased with how Ferrer is continuing to execute on its planned commercial launch across Europe.”

Alexza received marketing authorization for ADASUVE from the European Commission in February 2013. ADASUVE is the first inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder authorized for marketing in the EU. Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder. Agitation is a common symptom for these patients, characterized by feelings of distress, anxiety, and loss of control. The marketing authorization for ADASUVE requires that patients receive regular treatment immediately after control of acute agitation symptoms. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional and that short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.

Alexza and Ferrer established a collaboration agreement in October 2011. Under the terms this agreement, Alexza is the exclusive supplier of ADASUVE and is responsible for all aspects of manufacture of the product. Ferrer is responsible for commercial activities and is expected to launch ADASUVE in additional EU countries throughout 2014.

ADASUVE combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic medicinal product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in intravenous-like pharmacokinetics and rapid systemic effects. ADASUVE has been approved for marketing in the US by the US FDA and in the EU by the European Commission. The authorization for ADASUVE in the EU differs from that in the US, with respect to the indication statement, dose regimen, available dose strengths, and risk mitigation and management plans.

Alexza Pharmaceuticals is focused on the research, development, and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. For more information, visit www.alexza.com.