Alexza Pharmaceuticals, Inc. and privately-held European R&D-based pharma company, Grupo Ferrer Internacional, S.A. have launched Adasuve inhalation powder, pre-dispensed (Staccato loxapine) in Austria.
Grupo Ferrer is Alexza's commercial partner for Adasuve in the European Union (EU), Latin America, Russia and the CIS countries. Ferrer is commercializing Adasuve in Austria through a distribution agreement with AOP Orphan Pharmaceuticals AG, Austria.
"With the launch of Adasuve in Austria, Ferrer continues to execute on its commercialization of the product. We are very pleased with Ferrer's progress in making Adasuve available in an increasing number of countries throughout the EU," said Thomas B King, president and CEO of Alexza. "One of Alexza's key priorities is to support the global roll-out of Adasuve, with manufacturing and other support activities, in collaboration with our commercial partners."
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. The marketing authorization for Adasuve requires that patients receive regular treatment immediately after administration of the product to control acute agitation symptoms. It also requires that Adasuve be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should also be available for treatment of possible severe respiratory side effects, such as bronchospasm.
Alexza and Ferrer estimate that as many as eight million adults in the EU alone suffer from schizophrenia or bipolar disorder. Agitation is a common symptom for these patients, characterized by feelings of distress, anxiety and loss of control.
Under the terms of the collaboration agreement between Alexza and Ferrer, which was announced in October 2011, Alexza is the exclusive supplier of Adasuve, responsible for all aspects of manufacture of the product in its California facility. Ferrer is expected to launch Adasuve in additional EU countries in 2013 and 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 United States by the US Food and Drug Administration 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.
Grupo Ferrer is a privately-held European R&D-based pharmaceutical company and active in the pharmaceutical, health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.