BARCELONA, Spain, Oct. 14, 2015 /PRNewswire/ -- Grupo Ferrer
Internacional, SA (Ferrer) and Alexza Pharmaceuticals, Inc.
(Alexza) (Nasdaq: ALXA) today provided an update on the commercial
activities related to ADASUVE® inhalation powder,
pre-dispensed (Staccato® loxapine) in the European Union
(EU) and Latin America. Ferrer is Alexza's commercial partner
for ADASUVE in the European Union, Latin
America, Korea, Philippines, Thailand, countries in the Commonwealth of
Independent States and the Middle
East and North Africa
(Ferrer Territory).
"We continue to dedicate substantial efforts toward ADASUVE's
success. The feedback we are receiving distinguishes ADASUVE
as a highly valuable medication, one that provides superior
treatment to patients and a better tool to physicians.
ADASUVE is changing the paradigm of current treatment. This
paradigm change requires time and substantial, sustained efforts to
achieve significant business. We are determined to bring
ADASUVE to the patients that could benefit from it," said
Antoni Villaro, Chief Operating
Officer of Ferrer. "As part of our global partnership, we
have recently provided financing to Alexza through a short-term
loan as the Company goes through strategic evaluation of its
business. We remain strong, long-term supporters of Alexza
and of ADASUVE."
"Ferrer is leading the way in penetrating the target markets in
its territory and bringing ADASUVE to fill the unmet need for
patients and their families. We remain confident in ADASUVE's
long-term commercial prospects," said Thomas B. King, President and CEO of Alexza
Pharmaceuticals. "We are aware there are considerable
challenges in launching a hospital product, especially one as
unique and novel as ADASUVE. We continue to be impressed with
the hard work and progress Ferrer is making on the commercial
front, as well as on the clinical development and regulatory
fronts. This work is focused on evaluating markets and
real-world use of the product, with the goals of implementing
appropriate changes and potential label expansions that would allow
product availability in expanded markets."
Since the last reported European and Latin America update in September 2014, Ferrer has made the following
progress:
- ADASUVE is now available in 283 hospital settings in the EU,
compared to approximately 160 hospitals one year ago, an increase
of 77%.
- ADASUVE has experienced continued sustained growth in product
sales. Unit sales during the first half of 2015 were more
than 6 times the number of ADASUVE units sold in the first half of
2014.
- Alexza and Ferrer continue to receive strong and consistent
feedback from healthcare professionals across all countries in
Europe. Countries with routine use of ADASUVE include
Germany, Romania, Sweden, Norway, Finland, Denmark and Spain. The rest of the EU
countries, where ADASUVE is commercially available, are in the
process of listing the product in the hospital formularies, and
gaining initial trial and use with patients in hospitals in these
countries.
- ADASUVE is commercially available in 15 countries in
Europe and three countries in
Latin America, compared to a total
of eight countries a year ago. During the next six months,
Ferrer expects to launch ADASUVE in additional European countries
including the United Kingdom,
Italy, Netherlands and Bulgaria. ADASUVE
registration activities are ongoing for Brazil, Mexico and Turkey.
- Ferrer recently met with the EU regulatory authorities to
explore the potential modification of the ADASUVE label in
Europe to allow the use of the
product in the outpatient setting.
- In the past year, there have been five publications in
peer-reviewed journals addressing both clinical experience with
ADASUVE and the pharmacoeconomics of using ADASUVE, highlighting
the costs and burden of established habits of dealing with agitated
patients. In addition, 20 reports covering clinical
experiences with ADASUVE have been presented at different
congresses (International, European and regional within
Europe). Reported clinical
experience with ADASUVE continue to demonstrate the positive
outcomes in terms of safety and efficacy, as well as the
convenience of ADASUVE administration for both patients and health
care professionals.
- During the second and third quarters of 2015, Alexza and Ferrer
successfully conducted three GMP inspections of the Alexza
manufacturing facility that provides ADASUVE for countries within
the Ferrer Territory, including inspections by EMA (EU), ANVISA
(Brazil) and TITCK (Turkey). These inspections are part of
the ongoing regulatory review processes for ADASUVE.
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 in the EU, including the Summary of
Product Characteristics and Patient Information Leaflet approved in
the EU, please visit the EMA website.
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, please 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 and development pipeline are based on the
Staccato® system, a hand-held inhaler designed to
deliver a pure drug aerosol to the deep lung, providing rapid
systemic delivery and therapeutic onset, in a simple, non-invasive
manner. Active pipeline product candidates include AZ-002
(Staccato alprazolam) for the management of epilepsy in
patients with acute repetitive seizures and AZ-007 (Staccato
zaleplon) for the treatment of patients with middle of the night
insomnia.
ADASUVE® is Alexza's first commercial product and has
been approved for sale by the U.S. Food and Drug Administration,
the European Commission and in several Latin American
countries. Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical
Industries Ltd., is Alexza's commercial partner for ADASUVE in the
United States. Grupo Ferrer Internacional SA is Alexza's
commercial partner for ADASUVE in Europe, Latin
America, the Commonwealth of Independent States countries,
the Middle East and North Africa countries, Korea, Philippines and Thailand.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc. For more
information about Alexza, the Staccato system technology or
the Company's development programs, please visit
www.alexza.com.
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 anticipated
commercial launch of ADASUVE in any domestic or international
market or the outcome of any registration activities related
thereto, 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,
2014 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 (95% have agitation) and bipolar
patients (87% have agitation).
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SOURCE Alexza Pharmaceuticals, Inc.