MOUNTAIN VIEW, Calif. and
BARCELONA, Spain, March 13, 2014 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) and Ferrer today announced
that ADASUVE® inhalation powder, pre-dispensed
(loxapine) is now available in Romania. Ferrer is Alexza's
commercial partner for ADASUVE in the European Union (EU),
Latin America and the Commonwealth
of Independent States countries. Ferrer is commercializing
the product in Romania through a
distribution agreement with Galenica, S.A.
"With the launch of ADASUVE in Romania, Ferrer is continuing to execute on
its planned commercial launch. We are very pleased with
Ferrer's progress in making ADASUVE available in the EU," said
Thomas B. King, President and CEO of
Alexza. "Manufacturing finished product for our commercial
partners is one of Alexza's key priorities and we continue to
support the global introduction of ADASUVE."
Alexza received marketing authorization for ADASUVE from the
European Commission in February 2013. ADASUVE is the first
inhalation therapy for the rapid control of mild-to-moderate
agitation in adult patients with schizophrenia or bipolar disorder
authorized for marketing in the EU. 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 also 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 alone 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 Grupo
Ferrer Internacional S.A. 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 in its Mountain View,
California facility. Ferrer is expected to launch
ADASUVE in additional EU 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 has been approved for marketing in the United States by the U.S. Food and Drug
Administration and in the EU by the European Commission. 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:
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002400/human_med_001618.jsp&mid=WC0b01ac058001d124.
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.ferrergrupo.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®, Alexza's first commercial product, has been
approved for sale by the U.S. Food and Drug Administration and the
European Commission. 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.
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 our 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, 2012 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 and
bipolar patients).
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SOURCE Alexza Pharmaceuticals, Inc.