Spanish inspectors acting for the European Union apparently have been kinder to Alexza Pharmaceuticals than their U.S. counterparts after an inspection of the struggling drugmaker's California manufacturing facility.
Alexza ($ALXA) says it has received its EU Certificate of GMP Compliance of a Manufacturer, valid through May 15, 2015. The inspection was conducted by the Agencia Espanola de Medicamentos y Productos Sanitarios in May. Alexza has applied for approval in both the U.S. and the EU for its antipsychotic drug Adasuve and has a commercial agreement with Barcelona-based Grupo Ferrer Internacional.
At about the same time that Spanish inspectors were giving the heads-up to the plant, U.S. regulators denied the company's application for Adasuve--a quick-acting inhaled version of the old drug loxapine for outbursts from schizophrenia and manic episodes--in a complete response letter (CRL). The FDA said the denial was based on manufacturing problems.
The FDA told Alexza: "During a recent inspection of the Mountain View, CA, manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved." Alexza believes the deficiencies are medical-device-specific and readily addressable. Alexza, which saw shares free-fall nearly 33% on the news, said at the time in May that it would meet with U.S. regulators as soon as possible to "gain a better understanding of the specific deficiencies," pointing out that no new safety or clinical issues cropped up in the letter.
Alexza has been through the regulatory ringer on the drug, which promises patients with schizophrenia and bipolar I the benefits of easy administration and fast activity of loxapine. The inhaled version of the drug has raised concerns about its potentially deadly pulmonary effects and the risks associated with improper use of the treatment. Despite those concerns, the drug narrowly passed muster late last year in an FDA advisory panel's 9-8 vote to back approval. Yet the glow from that small victory quickly vanished when the FDA said in January that its decision on approval would be delayed by three months.
The company, which has trimmed its workforce to cut costs, in March had to tell investors that it only had cash on hand for the rest of 2012.
- see the Alexza press release
- read the earlier Alexza release
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