Cypress Bioscience, Inc. (NASDAQ: CYPB) today announced that it has
licensed Alexza Pharmaceutical's (NASDAQ: ALXA) Staccato nicotine
technology -- a novel electronic multidose delivery technology
designed to help people stop smoking. The innovative Staccato
nicotine technology is intended to improve on a well-validated
smoking cessation approach by delivering nicotine via inhalation,
thus mimicking the actual nicotine effects of smoking without the
deleterious side effects associated with cigarettes.
Jay D. Kranzler, MD, PhD, Chairman and Chief Executive Officer
of Cypress Bioscience, said, "We are pleased to expand our CNS
pipeline with this novel Staccato nicotine technology. The
electronics embedded within the Staccato delivery system allow for
the programmed, over-time reduction of nicotine intake, and may
ultimately lead to better management of nicotine cravings and
sustained smoking cessation. Given that the vast majority of
smokers trying to quit using existing therapies relapse within six
months, we see great potential in this novel technology and we are
excited about this transaction."
Kranzler continued, "Today's announcement demonstrates continued
progress on our strategic plan to acquire and develop innovative
CNS therapeutics that have the potential to address important unmet
medical needs. Developing novel therapies such as effective
nicotine replacement technology is consistent with our renewed
focus on CNS drug development. We expect to take this technology
into Phase 1 clinical trials in late 2011."
Neal Benowitz, MD, Professor of Medicine, Bioengineering &
Therapeutic Sciences, University of California, San Francisco, and
a specialist in nicotine addiction and smoking cessation, said, "A
pulmonary nicotine delivery device, like Staccato nicotine, may be
useful in addressing a pressing pharmacological problem in
overcoming nicotine addiction; namely, that acute cravings during
quit attempts are inadequately treated by current nicotine
replacement therapies. A device that provides for rapid absorption
of nicotine, combined with electronic controls to adjust doses to
facilitate tapering and cessation, is an advancement that the field
has been waiting for."
About Smoking
Despite decades of public health and medical intervention,
smoking remains one of the most preventable causes of death in the
United States(1). Smoking continues to exact a staggering toll on
human health, claiming more than 430,000 lives annually in the
U.S.(2,3) One in five deaths in the U.S. are attributable to
smoking related illness(2,4). While the vast majority of smokers
indicate an interest in quitting(5), approximately 80% of smokers
who try to quit on their own relapse in one month, and only 3% will
remain abstinent at six months(6). Current nicotine replacement
therapies (nasal, buccal and transdermal), nicotinic agonists, and
other prescription therapies approximately double the rates of
abstinence as compared to placebo, but even so the vast majority of
smokers using these treatments relapse within six months(7). The
scientific community has called for the development of a pulmonary
nicotine delivery system that more closely mimics the blood levels
of nicotine produced through smoking, as such a system could be
differentially effective in helping smokers to quit(7,8,9).
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.
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 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.
About Alexza Pharmaceuticals
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.
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 submitted a
New Drug Application for AZ-004 and has a PDUFA goal date of
October 11, 2010. For more information about Alexza, the Staccato
technology or the Company's development programs, please visit
www.alexza.com.
About Cypress Bioscience
Cypress Bioscience is a pharmaceutical company dedicated to the
development of innovative drugs targeting large unmet medical needs
for patients suffering from a variety of disorders of the central
nervous system. Since 1999, Cypress has received multiple FDA
approvals, including for Prosorba™, a medical device for rheumatoid
arthritis, and Savella® (milnacipran HCl), for fibromyalgia. The
Company focuses on generating stockholder value by reaching
clinical development milestones as quickly and efficiently as
possible. Cypress' currently marketed products include Savella and
the Avise PG(SM) and Avise MCV(SM) therapeutic monitoring,
diagnostic and prognostic testing services for rheumatoid
arthritis. Development-stage assets include CYP-1020 for cognitive
impairment in schizophrenia, as well as AVISE-SLE(SM), a lupus
diagnostic testing service. More information on Cypress and its
products and development assets is available at
http://www.cypressbio.com/.
Forward-Looking Statements
This press release, as well as Cypress' SEC filings and website
at http://www.cypressbio.com, contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements include statements with respect to the
potential of Staccato nicotine technology to improve upon existing
smoking cessation approaches and lead to better management of
nicotine cravings and sustained smoking cessation, statements with
respect to Staccato nicotine's mechanism of action, statements with
respect to Cypress's ability to license or sell the Staccato
nicotine technology, statements regarding the timing of Phase 1
clinical trials relating to the Staccato nicotine technology and
statements with respect to Cypress's ability to execute on its
strategic plan. Actual results could vary materially from those
described as a result of a number of factors, including risks
involved with the high uncertainty that characterizes research and
development activities in general, particularly those of drug
development, including the risks that the Staccato nicotine
technology may not demonstrate adequate safety and/or efficacy in
clinical trials to continue with its development, may not have
adequate intellectual property right protection to support its
continued development, may be unable to obtain FDA or similar
regulatory approval as a drug candidate for any of many reasons
relating to the regulatory approval process, or may address a
commercial market that is smaller than currently anticipated by
Cypress and that does not support its continued development, or
that Cypress may otherwise fail to successfully develop and
commercialize the Staccato nicotine technology, and other risks and
uncertainties described in Cypress' most recent Annual Report on
Form 10-K, most recent Quarterly Report on Form 10-Q and any
subsequent SEC filings. You are urged to consider statements that
include the words "may," "will," "would," "could," "should,"
"believes," "potential," "expects," "plans," "anticipates,"
"intends," or the negative of those words or other comparable words
to be uncertain and forward-looking. The statements in this press
release speak only as the date hereof, and neither Cypress nor
Alexza undertakes any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
(1) Danaei G, et al. (2009) The Preventable Causes of Death in
the United States: Comparative Risk Assessment of Dietary,
Lifestyle, and Metabolic Risk Factors. PLoS Med 6(4): e1000058.
doi:10.1371/journal.pmed.1000058. (2) Centers for Disease Control
and Prevention. The health consequences of smoking: a report of the
Surgeon General. Atlanta, GA: US Department of Health and Human
Services, CDC; 2004. Available at
http://www.cdc.gov/tobacco/data_statistics/sgr/sgr_2004/index.htm.
(3) Centers for Disease Control and Prevention.
Smoking-Attributable Mortality, Years of Potential Life Lost, and
Productivity Losses -- United States, 2000-2004. Morbidity and
Mortality Weekly Report 2008;57(45):1226-8 [accessed 2010 Jul 25].
(4) Centers for Disease Control and Prevention. Health, United
States, 2008. Hyattsville (MD): U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Center for Health Statistics, 2006. (5) Centers for Disease Control
and Prevention (2002). Cigarette smoking among adults -- United
States, 2000. MMWR Morbidity Mortality Weekly Report, 51, 642- 645.
(6) Hughes, JR, et al. (1992). Smoking cessation among
self-quitters. Health Psychology, 11, 331-334. (7) Henningfield,
JE, et al. (2005). Pharmacotherapy for Nicotine Dependence. CA
Cancer J Clin 2005;55;281-299 DOI: 10.3322/canjclin.55.5.281. (8)
Henningfield, JE, et al. (2009). Tobacco dependence and withdrawal:
Science base, challenges and opportunities for pharmacotherapy.
Pharmacology & Therapeutics, 123, 1-16. (9) Schroeder, SA &
Warner, KE. (2010). Don't forget tobacco. New England Journal of
Medicine: 10.1056/NEJMp1003883.
INVESTOR CONTACTS: MacKenzie Partners, Inc. Amy Bilbija / Bob
Marese 650-798-5206 / 212-929-5500 MEDIA CONTACTS: Joele Frank,
Wilkinson Brimmer Katcher Sharon Stern / Dara Silverstein
212-355-4449
Cypress Bioscience (NASDAQ:CYPB)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cypress Bioscience (NASDAQ:CYPB)
Historical Stock Chart
From Jul 2023 to Jul 2024