Alexza Pharmaceuticals Announces the Launch of ADASUVE® (inhalation powder,
loxapine) in the Nordic Countries
MOUNTAIN VIEW, Calif., April 30, 2014
MOUNTAIN VIEW, Calif., April 30, 2014 /PRNewswire/ --Alexza Pharmaceuticals,
Inc. (Nasdaq: ALXA) today announced that ADASUVE^® inhalation powder,
pre-dispensed (loxapine) is now available in the Nordic countries (Sweden,
Norway, Denmark and Finland). Grupo Ferrer Internacional, S.A. ("Ferrer") is
commercializing ADASUVE in the Nordic countries through a distribution
agreement with Medivir AB. Ferrer is Alexza's commercial partner for ADASUVE
in the Europe, Latin America and the Commonwealth of Independent States
"With the launch of ADASUVE in the Nordic Countries, Ferrer is continuing to
execute on its planned commercial launch. We are very pleased with their
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 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 disorder^1. Agitation is a common
symptom for these patients^2, 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 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
For the full prescribing information including boxed warnings for the U.S.,
please visit www.adasuve.com.
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
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. Grupo Ferrer Internacional S.A. is Alexza's commercial partner for
ADASUVE in Europe, Latin America and the Commonwealth of Independent States
ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals,
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.
Wittchen H.U., et al., 2011. The size and burden of mental disorders and
1. other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21,
2. Alexza data on file (primary market research among caregivers of patients
with schizophrenia and bipolar patients).
SOURCE Alexza Pharmaceuticals, Inc.
Contact: Thomas B. King, President and CEO, 650.944.7634, email@example.com, or
Mark K. Oki, SVP, Finance and CFO, 650.944.7666, firstname.lastname@example.org
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