Alexza Pharmaceuticals and Ferrer announce launch of Adasuve in Romania

Ferrer is Alexza’s commercial partner for Adasuve in the EU, Latin America and the Commonwealth of Independent States countries. Ferrer is commercializing the product in Romania through a distribution agreement with Galenica.

Alexza president and CEO Thomas B. King with the launch of ADASUVE in Romania, Ferrer is continuing to execute on its planned commercial launch.

"We are very pleased with Ferrer’s progress in making ADASUVE available in the EU. Manufacturing finished product for our commercial partners is one of Alexza’s key priorities and we continue to support the global introduction of ADASUVE," King added.

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 8 million adults in the EU alone suffer from schizophrenia or bipolar disorder. Agitation is a common symptom for these patients2, characterized by feelings of distress, anxiety and loss of control.

Alexza Pharmaceuticals and Grupo Ferrer Internacional are parties to the collaboration agreement for Adasuve pursuant to which Alexza, as the exclusive supplier of Adasuve, is responsible for all aspects of manufacture of the product in its Mountain View, California facility. Ferrer is expected to launch Adasuve in additional EU countries in 2014 and 2015.

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 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.