Profile: Alexza Pharmaceuticals, Inc. (ALXA.O)

Alexza Pharmaceuticals, Inc., incorporated on December 19, 2000, is a specialty pharmaceutical company focused on the development and commercialization of products for the treatment of acute and intermittent conditions. The Company has six product candidates in clinical development. Its technology, the Staccato system, vaporizes excipient-free drugs to form condensation aerosols that, when inhaled, allows for rapid systemic drug delivery. The Company is initially focusing on developing products by combining its Staccato system with small molecule drugs that have been in use for many years and are well characterized to create aerosolized forms of these drugs.

Alexza Pharmaceuticals is developing AZ-004 for the treatment of acute agitation in patients with schizophrenia or bi-polar disorder. In December 2008, the Company announced positive results from the second of its two Phase III clinical trials of AZ-004. This trial enrolled 314 acutely-agitated patients with bipolar I disorder at 17 United States clinical centers. The trial was designed as an in-clinic, multi-center, randomized, double-blind, placebo-controlled study, and tested AZ-004 at two dose levels, five milligram and 10 milligram. Patients were eligible to receive up to three doses of study drug in a 24-hour period, depending on their clinical status. Only one dose of study drug was allowed during the first two hours of the study period. Patients eligible for the study included those who were admitted through an emergency department and those who were already in-patients in a hospital setting, as long as they had acute agitation at the time of patient randomization. This study was the first AZ-004 study enrolling bipolar disorder patients. The primary endpoint for the study was a reduction of agitation, measured as the change from baseline in the PANSS, or Positive and Negative Symptom Scale, Excited Component Score, also known as the PEC score, measured at two hours after the first dose. The key secondary endpoint was the Clinical Global Impression-Improvement (CGI-I), score, measured at two hours after the first dose. Both the 5 milligram and 10 milligram doses of AZ-004 met these primary and secondary endpoints.

Alexza Pharmaceuticals is developing AZ-001 and AZ-104 for the treatment of acute migraine headaches. Although there are numerous products available for the treatment of migraines, including simple analgesics, such as aspirin and acetaminophen, and nonsteroidal anti-inflammatory drugs, such as ibuprofen and naproxen, the prescription market is dominated by a class of orally administered medications commonly known as triptans. The API of AZ-001 is prochlorperazine, a generic drug belonging to the class of drugs known as phenothiazines. Prochlorperazine is approved in oral, injectable and suppository formulations in the United States for the treatment of several indications, including nausea and vomiting. In several published clinical studies, 10 milligram of prochlorperazine administered intravenously demonstrated effective relief of migraine pain. Prochlorperazine is often administered intravenously to patients with severe migraine headaches who come to emergency departments or migraine treatment clinics. AZ-104 is also being developed to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose version of AZ-004. In March 2008, the Company announced initial results of an in-clinic, multi-center randomized, double-blind, single administration, placebo controlled Phase II a proof-of-concept clinical trial in 160 migraine patients with or without aura. AZ-104 met the primary efficacy endpoint of the clinical trial for the two highest doses of the drug compared to placebo. Using survival analysis for pain relief response, all three dose groups were statistically superior to placebo during the four-hour post-treatment time period that the patients remained in the clinic.

Alexza Pharmaceuticals is developing AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. In April 2008, the Company announced positive results from a Phase I clinical trial of AZ-007. The Company is developing AZ-003 for the treatment of patients with acute pain, including patients with cancer pain and postoperative patients with acute pain episodes. It has completed and announced positive results from a Phase I clinical trial of AZ-003. Z-002 has completed a Phase I clinical trial in 50 healthy volunteers and a Phase IIa proof-of-concept clinical trial for the treatment of panic attacks.