Alexza Pharmaceuticals is a rapidly emerging pharmaceutical company focused on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system, or CNS conditions. All of our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes excipient-free drugs to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Because of the ideal particle size of the aerosol, the pure drug is quickly absorbed through the deep lung into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous (IV) administration but with greater ease, patient comfort and convenience.
Alexza's lead program is ADASUVE™ (Staccato loxapine or AZ-004), being developed for the acute treatment of agitation in patients with schizophrenia or bipolar disease, and has regulatory approval in both the United States and Europe.
- In October 2011, Alexza entered into a commercial partnership for ADASUVE™ with Grupo Ferrer Internacional, S.A. for the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
- In October 2011, Alexza filed its Marketing Authorization Application (MAA) for ADASUVE with the European Medicines Agency (EMA).
- In May 2012, Alexza received a Complete Response Letter (CRL) from the FDA regarding our ADASUVE NDA in which manufacturing deficiencies were noted by the FDA. There were no new clinical or safety issues identified, and there were no other deficiencies outlined.
- In June 2012, Alexza resubmitted the ADASUVE NDA seeking marketing approval for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In July 2012, the FDA accepted the resubmission as a complete class 2 response and indicated a Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012. Alexza received FDA Approval in December 2012.
- In February 2013, Alexza received Marketing Authorization for ADASUVE™ (inhalation powder, Loxapine) in the European Union.
To summarize, our efforts have been highly focused on what we felt were the key drivers of stockholder value, the continued hard work on moving ADASUVE forward to commercialization.
We believe we are pioneering a genuinely revolutionary technology that can greatly improve the treatment of many patients suffering with acute and intermittent conditions, and in some cases, fundamentally change the way that medicine is practiced. We accomplished the goals to bring the company's first product, ADASUVE, through the NDA and MAA review and approval processes, while at the same time, finding ways to continue to develop our other product candidates.