Blue Mountain Quality Resources, Inc. announced today that Alexza Pharmaceuticals has chosen Blue Mountain Regulatory Asset Manager to manage the maintenance, calibration and validation of their assets.
“We have set aggressive goals for Facilities and manufacturing equipment management, including the implementation of a more proactive Total Productive Maintenance (TPM) approach,” said Jeffrey Harstead, Facilities Manager at Alexza Pharmaceuticals. “Blue Mountain Regulatory Asset Manager will enable us meet our goals, harmonize all activity around equipment management in a single application and streamline processes while satisfying regulatory requirements.”
By working with Blue Mountain for the implementation of the system, Alexza Pharmaceuticals will benefit from Blue Mountain’s extensive experience in equipment management in the life sciences, incorporating industry best practices and reducing the total time and cost of an implementation catered to their specific needs and objectives.
About Alexza Pharmaceuticals
Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza’s technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.
AZ-004 (Staccato loxapine) is Alexza’s lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, submitted a New Drug Application submission in December 2009, and has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. In February 2010, Alexza established a partnership with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 in the U.S. and Canada.
Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.
AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at www.alexza.com.
About Blue Mountain Quality Resources, Inc.
Blue Mountain Quality Resources, Inc. is the validated leader in regulatory asset management. Blue Mountain Regulatory Asset Manager, the company’s flagship software product, is a comprehensive integrated browser-based solution designed to enable the collaboration of maintenance, calibration and quality personnel to manage the validated state of assets and processes. With 15 years of experience in FDA-regulated and ISO-compliant markets and over 1000 life science implementations, Blue Mountain offers a complete solution from set-up and installation to training and validation.