Positive EU regulatory news for Alexza and Ferrer, but not Gentium

USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received marketing approval from the European Commission has granted marketing authorization for Adasuve (Staccato loxapine) for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.

The Adasuve marketing authorization requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that Adasuve is administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).

Alexza president and chief executive Thomas King commented: "Our EU partner, Grupo Ferrer, is preparing for Adasuve’s launch and we are very pleased to support their pre-launch efforts. We are planning to launch Adasuve in the third quarter, in both the US and the EU."