Company Overview

Alexza Pharmaceuticals is a rapidly emerging pharmaceutical development 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 currently has five product candidates in various stages of clinical development, and one product candidate for which clinical trials have been completed and an NDA has been submitted.

In 2009:

• We submitted our first NDA for our Staccato technology. In December, one quarter ahead of schedule, we filed our AZ-004 (Staccato loxapine) NDA. AZ-004 is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
• During the year, we initiated and completed five non-pivotal safety and NDA-supporting studies for AZ-004. We completed our pre-NDA meeting with the FDA. Our NDA submission contains data from more than 1600 patients and subjects who were studied in thirteen different clinical trials.
• Data from our pivotal Phase 3 studies with AZ-004 were presented at several major medical meetings, including the American Psychiatric Association, the Institute of Psychiatric Services, the U.S. Psychiatric and Mental Health Congress, and our first peer-reviewed medical article on AZ-004 was published in November.
• We excercised our option to purchase all of the equity of Symphony Allegro, reacquiring all product rights to AZ-004, AZ-104 and AZ-002.
• We initiated and completed our Phase 2b study with AZ-104 (low-dose Staccato loxapine) for migraine. Data from this 360 patient study trended toward statistical significance, but the study did not meet its primary endpoint compared to placebo. AZ-104 was generally safe and well tolerated in this patient population.

We are particularly pleased to note that these many accomplishments reflect progress in both the product development and pre-commercialization sides of our business. To complete our first product NDA submission, our clinical development has been especially rapid, and we have actively been focusing on the infrastructure for commercial manufacturing and global supply chain activities, along with other pre-commercialization activities for AZ-004.

We believe we are pioneering a genuinely revolutionary technology that can greatly improve the treatment of many patients suffering with acute and intermittent conditions. Our overriding goals are to bring the company’s first product, AZ-004, through the NDA approval process, while continuing to develop our other product candidates.

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