Company Overview

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 processes ongoing in both the United States and Europe.

Recent Highlights:

• 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.  Alexza believes the deficiencies are medical-device specific and readily addressable. We plan to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical.  Alexza looks forward to working to resolve the remaining issues in a timely manner.

To summarize, our efforts in early 2012 were highly focused on what we felt were the key drivers of stockholder value, the continued hard work on moving ADASUVE forward in its regulatory processes.

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. Our overriding goals are 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.