MOUNTAIN VIEW, Calif. and
BARCELONA, Spain, Oct. 27, 2014 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A. (Ferrer)
announced today that they have amended their agreement for
ADASUVE® (Staccato® loxapine). Ferrer
is Alexza's commercial partner for ADASUVE in the European Union,
Latin America and the Commonwealth
of Independent States countries (the Ferrer Territory). Ferrer and
Alexza have agreed that Ferrer will purchase 2 million shares of
Alexza common stock for $4.00 per
share, thereby becoming the Company's largest shareholder. The
purchase represents a combination of new investment and
consideration for the elimination of certain future potential
milestone payments under the agreement.
"Ferrer and Alexza's collaboration has been focused on building
the market for ADASUVE in our territory and a lasting relationship
between the companies," said Jordi
Ramentol, Chief Executive Officer of Ferrer. "The expansion
of our relationship with Alexza with this strategic investment
demonstrates our belief in ADASUVE as a highly valuable therapy,
something we also hear from physicians and patients who have had
experience with this product. We are pleased to continue our work
together to build ADASUVE into a global brand."
"We have been very pleased with Ferrer's commitment and progress
in bringing ADASUVE to patients since the first country launch in
Germany in the summer of 2013. In
addition to ADASUVE now being available in nine EU countries,
Ferrer has secured three ADASUVE approvals in Latin America," said Thomas B. King, Alexza's President and CEO. "We
continue to see momentum in the uptake of ADASUVE and consistently
hear from physicians about the clinical benefits that ADASUVE can
convey to the patients they treat."
King concluded, "We are excited Ferrer is making this strategic
investment in Alexza, which reinforces Ferrer's commitment to
ADASUVE as an important new therapeutic and to the long-standing
collaboration between our two companies."
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, is based on the
Staccato technology, and has been approved for sale by the
U.S. Food and Drug Administration, the European Commission,
and in Chile, Costa Rica and 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:
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.