MOUNTAIN VIEW, Calif.,
Aug. 26 /PRNewswire-FirstCall/ --
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it
has licensed its Staccato nicotine technology to Cypress
Bioscience, Inc. (Nasdaq: CYPB). The Staccato nicotine
technology is a novel electronic multidose delivery system designed
to help people stop smoking. The Staccato nicotine
technology is intended to improve on a well-validated smoking
cessation approach by delivering nicotine via inhalation, mimicking
the nicotine effects of smoking without the harmful side effects
associated with cigarettes.
"The Staccato system is a broad technology platform and
Alexza has more Staccato-based product candidates than we
can currently afford to develop on our own. In early July, we
outlined our strategy to advance Staccato-based product
candidates into development through self-funding and through
collaborations," said Thomas B.
King, Alexza President and
CEO. "Today's announcement of the licensing of our
Staccato nicotine technology to Cypress, along with our
recently announced plans to advance AZ-007 (Staccato
zaleplon) into Phase 2 clinical development, are examples of our
execution of this dual-tracked development strategy."
Financial Information
According to the terms of the agreement, Cypress will pay Alexza
an upfront payment of $5 million to
acquire the worldwide license for the Staccato nicotine
technology. In addition, following the completion of certain
preclinical and clinical milestones relating to the Staccato
nicotine technology, Cypress will be obligated to pay to Alexza an
additional technology transfer payment of $1
million. Alexza will have a carried interest of 10%
(subject to adjustment in certain circumstances) in the net
proceeds of any sale or license by Cypress of the Staccato
nicotine assets and the carried interest will be subject to put and
call rights in certain circumstances.
Under the agreement, Cypress has responsibility for preclinical,
clinical and regulatory aspects of the development of
Staccato nicotine, along with the commercialization of the
product. Alexza will execute a defined development plan for
Cypress, culminating with the delivery of clinical trial materials
for a Phase 1 study with Staccato nicotine.
About Staccato Nicotine
Staccato nicotine is designed to help smokers quit by
addressing both the chemical and behavioral components of nicotine
addiction by combining nicotine replacement via inhalation with a
user-friendly drug delivery device. The Staccato
technology may be capable of mimicking the pharmacokinetics of
smoking cigarettes through the delivery of optimally-sized nicotine
particles to the deep lung. Staccato nicotine may also
provide some of the psychological aspects of smoking (e.g.,
hand-to-mouth movement, oral inhalation) and could allow smokers to
self-administer and possibly titrate to the dose to treat cravings.
Importantly, the electronics embedded within the
Staccato delivery system could allow for the programmed,
over-time reduction in the overall daily dose of nicotine, and
ultimately may lead to the better management of nicotine cravings
and eventual sustained smoking cessation.
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 and safety of the Company's product
candidates 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.
Copyright . 26 PR Newswire