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From: pmony (Rep: 539)Date: 02/21/2013 09:14
Forum: Alexza Pharmaceuticals - Msg #915Thread #673503754 (Rec: 0)
Alexza Receives Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the European Union
PR NewswirePress Release: Alexza Pharmaceuticals, Inc. – 13 minutes ago

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Feb. 21, 2013 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (ALXA) and Grupo Ferrer Internacional, S.A., today announced that the European Commission has granted marketing authorization for ADASUVE (Staccato loxapine). In the European Union (EU), ADASUVE, 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized 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).

"The centralized EU marketing authorization for ADASUVE delivered by the European Commission is an important milestone for Alexza," said Thomas B. King, President and CEO of Alexza. "ADASUVE is the first authorized non-injectable therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. We believe that the ability to deliver this medicinal product rapidly and non-invasively will be important for patient care."

King continued, "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."

"Our focus with the initial EU launch of ADASUVE will be Germany and Austria in 2013, with a planned launch into the rest of the EU countries in 2014," said Jordi Ramentol, CEO of Grupo Ferrer. "At the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory, and we plan to complete all of these submissions before the end of 2013."

Ramentol continued, "ADASUVE is central to our near-term corporate strategy. We are very proud to bring this new technology to healthcare professionals for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder."

About ADASUVE (Staccato loxapine)

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 IV-like pharmacokinetics and rapid systemic effects.

The application for marketing authorization for ADASUVE submitted to the European Medicines Agency was based on Alexza's clinical development program that included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder. These two clinical trials demonstrated statistically significant reductions in agitation from baseline compared to placebo1,2. In studies in agitated patients, bronchospasm was reported as an uncommon, but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator. The most commonly reported adverse reactions during treatment with ADASUVE were dysgeusia, sedation/somnolence and dizziness (dizziness was more common after placebo treatment than loxapine treatment)1,2,3. Alexza and Ferrer estimate that as many as 8 million adults in the EU alone suf

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