MOUNTAIN VIEW, Calif., Sept.18,
2014 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:
ALXA) today provided an update on the commercial activities related
to ADASUVE® inhalation powder, pre-dispensed
(Staccato® loxapine) in the European Union (EU).
Grupo Ferrer Internacional, S.A.
(Ferrer) is Alexza's commercial partner for ADASUVE in the European
Union, Latin America and the CIS
countries (the Ferrer Territory). Ferrer has distribution
agreements with AOP Orphan Pharmaceuticals AG, Bioprojet, Galenica
SA, and Medivir AB for some of the countries in Europe.
ADASUVE is now available in nine countries in the Ferrer
Territory, after its initial launch in Germany in July 2013. Ferrer expects to
continue the roll-out of ADASUVE in additional EU countries through
2014 and 2015, with France being
the next major EU country targeted.
"We continue to hear consistent messages from doctors using
ADASUVE that it is an important alternative over injections or oral
tablets, and is also beneficial with building patient alliance and
patient compliance," said Antoni Villaró, Chief Operating Officer
of Ferrer. "We, at Ferrer, understood from the beginning that
ADASUVE is a highly valuable medication and needs time to achieve
significant business. That is why we continue to dedicate
substantial efforts and resources to its success."
Alexza and Ferrer provided the following updates on ADASUVE in
the EU:
- ADASUVE product supply is now available for the field sales
representatives in France, where
the first commercial sale is anticipated by year-end. Ferrer
is commercializing ADASUVE in France through a distribution agreement with
Bioprojet.
- ADASUVE is now available in more than 160 hospitals in the
EU.
- ADASUVE has experienced continued growth in product sales since
its introduction in July 2013. During the past year, unit
growth has tripled each quarter, as compared to each previous
quarter.
- Ferrer sponsored a symposium on agitation at the XVI World
Congress of Psychiatry, held in Madrid from September
14 - 18, 2014. The symposium, entitled "Management of
Psychomotor Agitation: New Approaches", was attended by more than
500 physicians, and included presentations and discussions about
agitation evaluation and pharmacologic treatment by experts in the
field, including Dr. Norman
Sartorius (Switzerland),
Dr. Frank Pajonk (Germany), Dr. Scott
Zeller (USA) and Dr.
Miquel Casas (Spain).
- Ferrer has launched a comprehensive international educational
course on the detection, assessment and management of agitation in
clinical practice. This course provides up to 42 continuing
medical education credits for completion of the course. For
more information, please see www.agitationinpsychiatry.com.
Physician Experience with ADASUVE
Dr. Gabriele Fischer, Professor at
the Department for Psychiatry and Psychotherapy, Medical University
of Vienna, Austria, said: "ADASUVE
is a great option for patients and their caregivers. Many
patients are sent home after the treatment and no hospitalization
is necessary."
Dr. Pedro Manuel Sánchez Gómez, from Hospital Psiquiatrico De
Alava Hospital Psiquiátrico de Vitoria, in Alava, Spain, summarized his experience using ADASUVE
to treat his patients, "ADASUVE is filling a gap where there is no
alternative. It is an important new option for those of us
who treat patients with agitation associated with schizophrenia or
bipolar disorder."
Dr. Hanut Oana, from the Psychiatric Hospital Elisabeta Doamna
in Galati, Romania, stated:
"ADASUVE is quick and elegant. It is a great option for
patients who have had unpleasant experiences with previous
treatments."
About ADASUVE (Staccato® loxapine)
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.
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.
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., 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:
- 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).
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SOURCE Alexza Pharmaceuticals, Inc.