Alexza Pharma Says CHMP Gives Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional,S.A., today announced that the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency (EMA) adopted a positive opinionrecommending that ADASUVE (Staccato loxapine) be granted European Union (EU)centralized marketing authorization.  The CHMP recommends that ADASUVE beauthorized in the EU for the rapid control of mild-to-moderate agitation inadult patients with schizophrenia or bipolar disorder.  Patients shouldreceive regular treatment immediately after control of acute agitationsymptoms.  The recommendation by the CHMP is that ADASUVE should beadministered only in a hospital setting under the supervision of a healthcareprofessional.  Short-acting beta-agonist bronchodilator treatment should beavailable for treatment of possible severe respiratory side-effects, such asbronchospasm.The positive opinion was based on Alexza's clinical development program thatincluded two randomized, multicenter Phase 3 pivotal studies of ADASUVE, whichenrolled 344 adult patients with schizophrenia and 314 adult patients withbipolar disorder.  These two clinical trials demonstrated statisticallysignificant reductions in agitation from baseline compared to placebo^1,2.Alexza estimates that as many as 8 million adults in the EU alone suffer fromschizophrenia or bipolar disorder^3.  Agitation is a common symptom for thesepatients^4.The CHMP positive opinion will now be forwarded to the European Commission,which has the authority to grant marketing authorization for medicinalproducts in the EU.  The marketing authorization expected to be delivered bythe European Commission would be applicable in all 27 EU Member States, plusIceland, Liechtenstein and Norway.  A decision is expected from the EuropeanCommission in the first quarter of 2013.  Alexza filed the ADASUVE MarketingAuthorization Application (MAA) with the EMA in October 2011.