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8-K - FORM 8-K - Alexza Pharmaceuticals Inc. | d78211e8vk.htm |
Exhibit 99.1
NEWS RELEASE for immediate release
Alexza Pharmaceuticals Provides Regulatory Update
for AZ-004 (Staccato® Loxapine)
for AZ-004 (Staccato® Loxapine)
Mountain View, California December 7, 2010 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug
Administration (FDA) in December to discuss the Complete Response Letter (CRL) regarding the
Companys New Drug Application (NDA) for AZ-004 (Staccato loxapine). Alexza has submitted an
Information Package to the FDA in preparation for the meeting, with the responses or proposals to
the issues raised in the CRL. AZ-004 is being developed for the rapid treatment of agitation in
schizophrenia or bipolar disorder patients.
The Company anticipates the FDA meeting will be a comprehensive review of the issues identified by
the FDA in the CRL, and Alexzas planned responses to those issues. The Companys primary meeting
goal is to clarify and fully understand the key issues, and to establish a plan to respond to those
issues. While the CRL follow-up meeting will be held in December, the Company does not expect the
official FDA meeting minutes to be available until at least late January 2011. The Company
anticipates providing a further U.S. regulatory update on AZ-004 after receipt of the official FDA
correspondence.
Alexza also announced today that it has met with the European Medicines Agency (EMA) and has
received written confirmation that AZ-004 is eligible for submission of a Marketing Authorization
Application (MAA) under the centralized registration procedure. In addition, Alexza has been
notified of the Rapporteur and Co-Rapporteur appointments for the AZ-004 review. The Company
believes that the comprehensive clinical development program for AZ-004 meets the requirements for
the MAA filing. Alexza expects to submit the MAA mid-year 2011.
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. 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
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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 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 is currently evaluating the FDAs comments in the CRL and has scheduled a meeting with
the FDA in December 2010 to discuss the CRL.
For more information about Alexza, the Staccato technology or the Companys development programs,
please visit www.alexza.com.
Safe Harbor Statement
This press release includes forward-looking statements regarding the development and safety of the
Companys product candidates and technologies. 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. The Companys 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 Alexzas business are
described in additional detail in the Companys Annual Report on Form 10-K for the year ended
December 31, 2009, and the Companys other Periodic and Current Reports filed with the Securities
and Exchange Commission including the risks under the headings: Regulatory authorities may not
approve our product candidates even if they meet safety and efficacy endpoints in clinical
trials., We have a history of net losses. We expect to continue to incur substantial and
increasing net losses for the foreseeable future, and we may never achieve or maintain
profitability., and We will need substantial additional capital in the future. If additional
capital is not available, we will have to delay, reduce or cease operations.. 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.
CONTACT: | Derek K. Cole Head, Investor Relations and Corporate Communications 650.944.7373 dcole@alexza.com |
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