MOUNTAIN VIEW, Calif.,
Aug. 8, 2014 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that
ADASUVE® inhalation powder, pre-dispensed (loxapine) is
now available in Guatemala.
This approval represents the first ADASUVE approval in
Latin America for Ferrer and
Alexza. Ferrer is Alexza's commercial partner for ADASUVE in
the EU, Latin America and
Commonwealth of Independent States countries.
Ferrer introduced ADASUVE during a psychiatric medical meeting
in Guatemala, hosted by Congreso
National de Psiquiatria de Guatemala, held in Guatemala City, August
7 - 8, 2014. During the meeting, Ferrer hosted a
symposium on agitation, entitled "ADASUVE: una innovacion
terapeutica en el tratamiento de la agitacion" or "ADASUVE: A
therapeutic innovation in the treatment of agitation."
"Ferrer is making strong progress in securing approvals for
ADASUVE," said Thomas B. King,
President and CEO of Alexza. "We are pleased with their
progress, as the Guatemala
approval represents Ferrer's first non-EU submission and approval
of ADASUVE."
"Launching ADASUVE in the first Latin American country is an
important milestone in our collaboration with Alexza and our
commercial plan for ADASUVE," said Antoni
Villaro, Chief Operating Officer of Ferrer. "We
believe ADASUVE provides an important new option for clinicians who
treat patients with agitation associated with schizophrenia or
bipolar disorder."
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 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.
Ferrer estimates that approximately 10 million adults in
Latin America suffer from
schizophrenia or bipolar disorder1. Agitation is a
common symptom for these patients2, characterized by
feelings of distress, anxiety, and loss of control.
Alexza Pharmaceuticals, Inc. and Ferrer are parties to the
collaboration agreement for ADASUVE pursuant to which Alexza, as
the exclusive supplier of ADASUVE, is responsible for all aspects
of manufacture of the product. Ferrer is expected to launch
ADASUVE in additional EU and Latin American countries in 2014 and
2015.
About ADASUVE (Staccato® loxapine)
ADASUVE combines Alexza's proprietary Staccato system with
loxapine, an antipsychotic medicinal product. The
Staccato system is a hand-held inhaler that delivers a drug
aerosol to the deep lung that results in intravenous-like
pharmacokinetics and rapid systemic effects.
ADASUVE® is Alexza's first commercial product and it
has been approved for sale by the U.S. Food and Drug
Administration, the European Commission and most recently in
Guatemala. Teva Pharmaceuticals USA, Inc. 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.
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 and it
has been approved for sale by the U.S. Food and Drug
Administration, the European Commission and most recently in
Guatemala. Teva Pharmaceuticals USA, Inc. 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:
- Kohn R, Levav I, Caldas de Almeida JM, Vicente B, Andrade L,
Caraveo-Anduaga JJ, Saxena S, Saraceno B.
Los trastornos mentales en America
Latina y el Caribe: asunto prioritario para la salud
publica. Re Panam Salud Publica. 2005;18(4/5):229-40.
- Alexza data on file (primary market research among caregivers
of patients with schizophrenia and bipolar patients).
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SOURCE Alexza Pharmaceuticals, Inc.