Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - Alexza Pharmaceuticals Inc. | d84029e8vk.htm |
Exhibit 99.1
NEWS RELEASE — for immediate release
Alexza Announces Resubmission of AZ-004 (Staccato®Loxapine) NDA
Application Seeks Marketing Approval for AZ-004 for the Rapid Treatment of Agitation
in Patients with Schizophrenia or Bipolar Disorder
in Patients with Schizophrenia or Bipolar Disorder
Mountain View, California — August 5, 2011 — Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced
today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) in response to a Complete Response Letter (CRL) received in October 2010. The
Company believes this is a Class 2 resubmission with a six-month review cycle. AZ-004 is being
developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.
In addition to the data from the original NDA and additional analyses of some of those data, the
AZ-004 resubmission contains new data from the successfully completed human factors study,
stability data from new production batches manufactured late last year, updated manufacturing and
controls sections addressing findings from the Company’s Pre-Approval Inspection, and updated draft
labeling and a comprehensive REMS proposal.
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. 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 schizophrenia 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. The Company completed an
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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. Alexza believes that the
AZ-004 NDA is a Class 2 resubmission and the review period will be 6 months, and that the FDA will
likely present the AZ-004 application to an Advisory Committee during the review period.
For more information about Alexza, the Staccato technology or the Company’s 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 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, including the adequacy of the Company’s capital to
support the Company’s current operations, the potential of the Company’s planned AZ-004 NDA
resubmission to adequately address the issues in the CRL, the timing of the FDA’s review of the NDA
and the eventual prospects that AZ-004 will be approved for marketing. 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, 2010, 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 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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