MOUNTAIN VIEW, Calif.,
Jan. 21, 2014 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced
that ADASUVE® inhalation powder, pre-dispensed
(Staccato® loxapine) is now available in Spain through Grupo
Ferrer Internacional, S.A. (Ferrer). Ferrer is
Alexza's commercial partner for ADASUVE in the European Union (EU),
Latin America, Russia and the CIS countries. In
conjunction with this commercial introduction of ADASUVE in
Spain by Ferrer, Alexza will
receive a milestone payment of $1
million.
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"Given that Ferrer is one of the largest Spanish pharmaceutical
companies, launching ADASUVE in our home market is an important
milestone," said Antoni Villaro,
Chief Operating Officer of Ferrer. "We expect to demonstrate
Ferrer's commitment to commercial excellence and hope to serve as a
reference for all other markets."
"Ferrer has consistently demonstrated a high degree of focus,
commitment and collaboration in introducing ADASUVE to physicians
who are seeking new therapeutic options for the treatment of
agitation associated with bipolar disorder or schizophrenia," said
Thomas B. King, President and CEO of
Alexza. "With the launch of ADASUVE in Spain, we are pleased with how Ferrer is
continuing to execute on its planned commercial launch across
Europe."
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. 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
marketing authorization for ADASUVE requires that patients receive
regular treatment immediately after control of acute agitation
symptoms. It also requires that ADASUVE be administered only
in a hospital setting under the supervision of a healthcare
professional and that short-acting beta-agonist bronchodilator
treatment should be available for treatment of possible severe
respiratory side-effects, such as bronchospasm.
Alexza and Ferrer established a collaboration agreement in
October 2011. Under the terms of this agreement, Alexza is
the exclusive supplier of ADASUVE and is responsible for all
aspects of manufacture of the product. Ferrer is responsible
for commercial activities and is expected to launch ADASUVE in
additional EU countries throughout 2014.
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 U.S.,
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.
Ferrer is Alexza's commercial partner for ADASUVE in
Europe, Latin America, Russia and the Commonwealth of Independent
States countries.
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 (Staccato loxapine) is Alexza's first commercial
product, which was approved by the U.S. Food and Drug
Administration in December 2012 and
by the European Commission in February 2013. 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, Russia 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:
- 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.
- Alexza data on file (primary market research among caregivers
of patients with schizophrenia (95% have agitation) and bipolar
patients (87% have agitation)).
SOURCE Alexza Pharmaceuticals, Inc.