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8-K - FORM 8-K - Alexza Pharmaceuticals Inc. | d83752e8vk.htm |
Exhibit 99.1
NEWS RELEASE for immediate release
Alexza to Announce 2011 Second Quarter Financial Results
on Monday, August 8, 2011
on Monday, August 8, 2011
AZ-004 (Staccato® loxapine) NDA Resubmission Now Planned for August 8, 2011
Conference Call Scheduled for 4:30 p.m. Eastern Time, August 8, 2011
Mountain View, California July 26, 2011 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
announced today that it will report financial results for the quarter ended June 30, 2011, on
Monday, August 8, 2011, following the close of the U.S. financial markets. Alexza also announced
that the resubmission of its
AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) is now planned for
Monday, August 8, 2011. The Company completed the writing of the NDA sections earlier this week.
The documents have been transferred to Alexzas electronic submission vendor who is assembling and
processing the files for eCTD (electronic Common Technical Document) submission to the FDA.
The entire Alexza organization has worked diligently toward the resubmission of our AZ-004 NDA,
said Thomas B. King, Alexza President and CEO. Our employees have combined their skills with
those of some outstanding outside consultants and advisors, who are experts in the key areas of
focus of our resubmission. In addition to the data in our original NDA, our resubmitted NDA
contains data from our successfully completed human factors study, stability data from new
production batches manufactured late last year, and a comprehensive REMS proposal and draft
labeling for AZ-004.
On Monday, August 8, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time, the Company will host an
investor conference call and live webcast to provide a company update, as well as to discuss the
financial results. The conference call, live webcast and archived replay are open to all
interested parties.
To access the conference call via the Internet, go to www.alexza.com, under the Investor
Relations link. Please join the call at least 15 minutes prior to the start of the call to ensure
time for any software downloads that may be required. Interested parties may also pre-register to
avoid pre-call delays at https://www.theconferencingservice.com/prereg/key.process?key=P844VRMWL.
To access the live conference call via phone, dial 888-713-4213. International callers may access
the live call by dialing +1-617-213-4865. The reference number to enter the call is 68061440.
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The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via phone
at 888-286-8010 for domestic callers or +1-617-801-6888 for international
callers. The reference number for the replay of the call is 14135984. A replay of the call will
be available for two weeks following the event.
About Alexza Pharmaceuticals, Inc.
Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexzas 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.)
Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexzas 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 Alexzas 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 and submitted the AZ-004
NDA in December 2009. In October 2010, the Company received a Complete Response Letter, or CRL,
from the FDA, regarding its NDA for AZ-004. A CRL is issued by FDAs Center for Drug Evaluation
and Research indicating that the NDA review cycle is complete and the application is not ready for
approval in its present form. The Company completed an end-of-review meeting with the FDA in late
December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in
April 2011.
For more information about Alexza, the Staccato technology or the Companys development programs,
please visit www.alexza.com.
Safe Harbor Statement
The anticipated news release and conference call will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Companys 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, including the adequacy of the Companys capital to support the Companys current operations, the potential of the Companys planned AZ-004 NDA resubmission to adequately address the issues in the CRL, the eventual prospects that AZ-004 will be approved for marketing and the timing of the Companys resubmission of the AZ-004 NDA to the FDA. The Companys forward-looking statements
The anticipated news release and conference call will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Companys 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, including the adequacy of the Companys capital to support the Companys current operations, the potential of the Companys planned AZ-004 NDA resubmission to adequately address the issues in the CRL, the eventual prospects that AZ-004 will be approved for marketing and the timing of the Companys resubmission of the AZ-004 NDA to the FDA. The Companys forward-looking statements
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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 Alexzas business are described in additional detail in the Companys Annual
Report on Form 10-K for the year ended December 31, 2010, and the Companys 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 the Company undertakes no obligation
to publicly update any forward-looking statement, whether as a result of new information, future
events or otherwise.
CONTACT:
|
Derek K. Cole Head, Investor Relations and Corporate Communications 650.944.7373 dcole@alexza.com |
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