MOUNTAIN VIEW, Calif.,
Dec. 16, 2014 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced
that it amended its commercial Manufacturing and Supply Agreement
("Supply Agreement") with Autoliv ASP Inc., the North American
subsidiary of Sweden-based Autoliv
Inc. Autoliv manufactures chemical heat packages, a key
component of Alexza's single-dose Staccato® system,
including Alexza's commercial product ADASUVE (Staccato
loxapine).
The amendment to the Supply Agreement between Alexza and
Autoliv, signed on December 12, 2014,
updates certain terms of prior agreements between the
companies. The Amendment states that the letter of
termination received by Alexza in October
2013 is null, and that the parties are extending the
agreement through 2018. In addition, Alexza has the right to
engage a second source supplier and implement a manufacturing line
transfer from Autoliv to manufacture and supply the chemical heat
packages to Alexza or its licensees.
"The amended agreement extends our ongoing partnership with
Autoliv, providing us with continued supply of this key component,
while enabling Alexza the flexibility to engage another supplier as
an alternate source of supply for heat packages," said
Robert A. Lippe, Executive Vice President, Operations and
Chief Operations Officer of Alexza. "We appreciate and value
Autoliv's operational excellence, cost efficiency, and
technological capabilities in manufacturing and scaled
production. We look forward to continuing to work with
Autoliv as it supplies heat packages in support of the expanding
global launch of ADASUVE."
Autoliv Agreement and Amendments
In November 2007, Alexza entered
into a Manufacturing and Supply Agreement with Autoliv, relating to
the commercial supply of chemical heat packages that can be
incorporated into Alexza's Staccato single-dose
device.
In June 2010 and February 2011, Alexza amended certain of the
terms of its Manufacturing and Supply Agreement with Autoliv.
Subject to certain exceptions, Autoliv agreed to manufacture,
assemble, and test the chemical heat packages solely for Alexza in
conformance with Alexza's specifications. In October 2013, Autoliv notified Alexza of its
intent to terminate the Manufacturing and Supply Agreement,
effective October 2016. Under
the terms of the new amendment to the Manufacturing and Supply
Agreement, Alexza and Autoliv agreed that, subject to certain
provisions, Autoliv will continue to provide heat packages, a key
component of ADASUVE, to Alexza to support the product uptake
in new and already launched markets.
About Staccato®
Staccato technology is a novel form of inhaled drug
delivery that is uniquely suited for conditions requiring speed of
therapeutic effect, reliable dosing, and ease of use.
Staccato system single-dose device houses a heat package
comprising a stainless steel substrate, which is coated with
excipient-free drug – the system requires no excipients or
pharmaceutical stabilizers. With a single breath by the
patient, the system rapidly actuates to form a drug aerosol of
consistent sized particles between one and three microns. At
this size, the particles are rapidly absorbed in the deep lung,
ensuring rapid uptake in the bloodstream and rapid onset of
pharmacological effect.
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 several Latin American countries.
Teva Pharmaceuticals USA, Inc.,
a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza's
commercial partner for ADASUVE in the U.S. Grupo Ferrer Internacional, S.A. (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, manufacturing, 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.
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SOURCE Alexza Pharmaceuticals, Inc.