Profile: Alexza Pharmaceuticals Inc (ALXA.O)

ALXA.O on Consolidated Issue listed on NASDAQ Global Market

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19 Aug 2014
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Alexza Pharmaceuticals, Inc. (Alexza), incorporated on December 19, 2000, is a pharmaceutical company focused on the research, development and commercialization of products for the acute treatment of central nervous system (CNS) conditions. Alexza’s product candidates are based on its technology, the Staccato system. The Staccato system vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for systemic drug delivery. As of December 31, 2011, the Company had screened more than 400 drug compounds, identifying approximately 200 drug compounds that demonstrate initial vaporization. The Company's product candidate is ADASUVE (Staccato loxapine). Its other product candidates in active development are AZ-007 (Staccato zaleplon) and Staccato nicotine. Its product candidates not in active development are AZ-104 (Staccato loxapine, low-dose), AZ-002 (Staccato alprazolam) and AZ-003 (Staccato fentanyl). In January 2011, Cypress was acquired by Royalty Pharma. In January 2014, Alexza Pharmaceuticals Inc announced that ADASUVE is available in Spain through Grupo Ferrer Internacional S.A.

Alexza is developing ADASUVE for the acute treatment of agitation in adults with schizophrenia or bipolar disorder. In August 2011, the Company resubmitted the ADASUVE NDA, which was accepted for filing by the Food and Drug Administration (FDA) as a complete, class 2 response to the FDA's CRL. The FDA indicated a Prescription Drug User Fee Act (PDUFA), goal date for the ADASUVE NDA of February 4, 2012. The Company has completed Phase I testing for AZ-007. This product candidate is being developed 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 the Phase I study, AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak drug concentration of 1.6 minutes. During the year ended December 31, 2011, it completed the process development work to transfer AZ-007 from its original single-dose clinical product device to the current single-dose commercial product device.

Staccato nicotine is designed to help smokers quit by addressing both the chemical and behavioral components of nicotine addiction by delivering nicotine replacement through inhalation. It has a license and development agreement, or the Cypress Agreement, with Cypress Bioscience, Inc. (Cypress), for Staccato nicotine. Under the Cypress Agreement, Cypress has responsibility for preclinical, clinical and regulatory aspects of the development of Staccato nicotine, along with the commercialization of the product.

AZ-104 is a lower-dose version of ADASUVE, is designed for the treatment of patients suffering from acute migraine headaches. AZ-104 has completed a Phase I clinical trial in healthy subjects and two Phase II clinical trials in patients with migraine headaches. AZ-002 has completed a Phase I clinical trial in healthy subjects and a Phase IIa proof-of-concept clinical trial in panic disorder patients for the treatment of panic attacks. The Company has completed and announced positive results from a Phase I clinical trial of AZ-003 in opioid-naive healthy subjects. This product candidate is designed for the treatment of patients with acute pain, including patients with breakthrough cancer pain and postoperative patients with acute pain episodes.

The Company’s Staccato system rapidly vaporizes an excipient-free drug compound to form a condensation aerosol that is inhaled and rapidly achieves systemic blood circulation through deep lung absorption. The Staccato system consistently creates aerosol particles averaging one to three and one-half microns in size, which is the most appropriate size for deep lung inhalation and absorption into the bloodstream. Its product candidates employing Staccato system consist of three core components: a heat source that includes an inert metal substrate; a thin film of an excipient-free drug compound, also known as an active pharmaceutical ingredient (API), coated on the substrate; and an airway through which the patient inhales. The left panel of the illustration below depicts these core components prior to patient inhalation.

Company Address

Alexza Pharmaceuticals Inc

2091 Stierlin Court
MOUNTAIN VIEW   CA   94043
P: +1650.9447000
F: +1650.9447999

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