Alexza Pharmaceuticals Inc. and Ferrer announced that Adasuve inhalation powder, pre-dispensed (loxapine), is now available in Romania. Ferrer is Alexza’s commercial partner for Adasuve in the European Union (EU), Latin America and the Commonwealth of Independent States countries. Ferrer is commercializing the product in Romania through a distribution agreement with Galenica SA.
“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,” said Thomas B. King, President and CEO of Alexza. “Manufacturing finished product for our commercial partners is one of Alexza’s key priorities and we continue to support the global introduction of Adasuve.”
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 patients, characterized by feelings of distress, anxiety and loss of control.
Alexza Pharmaceuticals Inc. and Grupo Ferrer Internacional SA 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, Calif., facility. Ferrer is expected to launch Adasuve in additional EU countries in 2014 and 2015.
Date: March 13, 2014