MOUNTAIN VIEW, Calif., Aug. 12 Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that Darl Moreland has joined the company as Vice President, Quality. He will have responsibility for Quality Assurance, Quality Control and Quality System regulatory compliance.
Mr. Moreland was most recently Vice President, Quality Assurance and Compliance, and Chief Compliance Officer for Mentor Worldwide LLC, a Johnson and Johnson company. Prior to joining Mentor Worldwide, Mr. Moreland was Senior Director, cGMP Quality Assurance at Conor Medsystems from September 2006 to July 2007. From May 2005 to September 2006, Mr. Moreland was Senior Director, Corporate Quality Engineering at Genentech, Inc., and he has also previously held positions at Guidant Corporation, ALZA Corporation, and Eli Lilly and Company. Mr. Moreland holds a Bachelor of Arts degree in chemistry from Indiana University-Purdue University at Indianapolis, Indiana.
"We are very pleased to welcome Darl to Alexza as a member of our management team," said Michael Simms, Senior Vice President, Operations and Manufacturing. "His broad Quality leadership experience in support of commercial products, and in the movement of combination products through the development process, will be instrumental as Alexza prepares for the planned launch of its first commercial product and continues to build its development pipeline."
About Alexza Pharmaceuticals, Inc.
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. (Click here to see an animation of how the Staccato system works.)
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 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 recently announced that it plans to advance AZ-007 (Staccato zaleplon) into Phase 2 clinical development, with the first Phase 2 clinical trial projected to begin in 1H 2011. AZ-007 is being developed for the treatment of insomnia in patients who have difficulty falling asleep, including those patients who awake in the middle of the night and have difficulty falling back asleep.
For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.
Safe Harbor Statement
This press release includes forward-looking statements regarding the development of the Company's product candidates, status of the FDA review of the NDA for AZ-004, and safety of the Company's products and technologies. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission.
Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Alexza Pharmaceuticals, Inc.