MOUNTAIN VIEW, Calif. and
BARCELONA, Spain, Dec. 11, 2014 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A. (Ferrer)
announced today that the Spanish-based publication Diario Medico
included ADASUVE® (Staccato® loxapine) in its
"Best Ideas of 2014" awards. The Best Ideas awards by Diario
Medico acknowledge the daily work of persons, institutions or
enterprises that contributed to the improvement of medicine,
healthcare, and public health during the previous year.
Ferrer is Alexza's commercial partner for ADASUVE in the European
Union, Latin America, and the
Commonwealth of Independent States countries.
"This award recognizes the innovation that is ADASUVE and its
contribution to the improvement in the quality of life of the
patients suffering from bipolar disorder and schizophrenia," said
Antoni Villaro, Chief Operating
Officer of Ferrer. "We continue to hear from doctors and
nurses who are using ADASUVE that they are impressed with ADASUVE's
strong efficacy and rapid onset as well as its potential to change
the practice in treating these patients."
"The Diario Medico Best Idea award exemplifies the vision of our
founder, Dr. Alejandro
Zaffaroni. He believed we could improve patient
therapies with our Staccato® technology, where drugs are
quickly vaporized to deliver alternative therapeutic options for a
variety of acute and intermittent conditions," said Thomas B. King, President and Chief Executive
Officer of Alexza Pharmaceuticals. "We believe ADASUVE's
combination of an effective drug in our Staccato system can
be a model for changing other suboptimal standard-of-care
regimens. Our primary focus in the near term remains
supporting the global commercialization of ADASUVE, and we also
look forward to building on the success of this first approved
product and developing other product candidates in the coming
years."
About Staccato®
Staccato technology is a
novel form of inhaled drug delivery that is uniquely suited for
conditions requiring speed of therapeutic effect, reliable dosing,
and ease of use. Staccato system single-dose device
houses a heat package comprising a stainless steel substrate, which
is coated with excipient-free drug – the system requires no
excipients or pharmaceutical stabilizers. With a single
breath by the patient, the system rapidly actuates to form a drug
aerosol of consistent sized particles between one and three
microns. At this size, the particles are rapidly absorbed in
the deep lung, ensuring rapid uptake in the bloodstream and rapid
onset of pharmacological effect.
About ADASUVE (Staccato loxapine)
ADASUVE combines Alexza's proprietary Staccato system with
loxapine, an antipsychotic medicinal product. ADASUVE is the
first and only inhalation therapy for the rapid control of
mild-to-moderate agitation in adult patients with schizophrenia or
bipolar disorder. The EU marketing authorization for ADASUVE
requires that patients receive regular treatment immediately after
administration of the product to control acute agitation
symptoms. It also requires that ADASUVE be administered
only in a hospital setting under the supervision of a healthcare
professional. Short-acting beta-agonist bronchodilator
treatment should be available for treatment of possible severe
respiratory side effects, such as bronchospasm.
Alexza and Ferrer estimate that as many as 8 million adults in
the EU suffer from schizophrenia or bipolar
disorder1. Agitation is a common symptom for these
patients2, characterized by feelings of distress,
anxiety, and loss of control.
The authorization for ADASUVE in the EU differs from that in
the United States, with respect to
the indication statement, dose regimen, available dose strengths,
and risk mitigation and management plans. For more
information about ADASUVE, including the Summary of Product
Characteristics and Patient Information Leaflet approved in the EU,
please visit the EMA website. For the full prescribing
information including boxed warnings for the U.S., please visit
www.adasuve.com.
About Ferrer
Founded in 1959, Ferrer is a privately-held European R&D-based
pharmaceutical company headquartered in Barcelona. It is
active in the pharmaceutical, health, fine chemicals and food
sectors in Europe, Latin America, Africa, the Middle
East, Asia and the United
States. In total, Ferrer's human healthcare products are
commercialized in more than 90 countries, through 27 international
affiliates (including joint ventures) and 70 partners and
distributors.
Ferrer carries out activities throughout the full pharmaceutical
value chain, from R&D to international marketing, including
fine chemical development and the manufacturing of both raw
materials and finished pharmaceuticals. Its research centers
in Spain and Germany, and manufacturing sites in
Europe and Latin America cover the pharmaceutical,
diagnostics, vaccine, fine chemical, food and feed sectors.
For more information, visit www.ferrer.com.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and
commercialization of novel, proprietary products for the acute
treatment of central nervous system conditions. Alexza's
products are based on the Staccato system, a hand-held
inhaler designed to deliver a drug aerosol to the deep lung,
providing rapid systemic delivery and therapeutic onset, in a
simple, non-invasive manner.
ADASUVE is Alexza's first commercial product, is based on the
Staccato technology, and has been approved for sale by the
U.S. Food and Drug Administration, the European Commission,
and in several Latin American countries.
Teva Pharmaceuticals USA, Inc.,
a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza's
commercial partner for ADASUVE in the U.S. Ferrer is Alexza's
commercial partner for ADASUVE in Europe, Latin
America and the Commonwealth of Independent States
countries. For more information, visit
www.alexza.com.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
This news release contains
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
ability of Alexza and its partners, Teva and Ferrer, to effectively
and profitably commercialize ADASUVE, estimated product revenues
and royalties associated with the sale of ADASUVE, the adequacy of
the Company's capital to support the Company's operations, and the
Company's ability to raise additional funds and the potential terms
of such potential financings. 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, 2013 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.
References:
1. Wittchen H.U., et al., 2011. The size and burden
of mental disorders and other disorders of the brain in
Europe 2010. Eur.
Neuropsychopharmacol. 21, 655-679.
2. Alexza data on file (primary market research
among caregivers of patients with schizophrenia (95% have
agitation) and bipolar patients (87% have agitation).
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SOURCE Alexza Pharmaceuticals, Inc.