MOUNTAIN VIEW, Calif.,
Oct. 30, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today
that it plans to reacquire the U.S. rights for ADASUVE®
(loxapine) inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical
Industries Ltd., with an estimated target completion date of
January 1, 2016. Alexza and
Teva also plan to restructure the obligations under the outstanding
note from Teva. Alexza and Teva are working on a transition
agreement to continue product availability to patients and health
care providers after the return of the rights to Alexza.
"ADASUVE is an effective product. There are considerable
challenges in launching a hospital product, especially one as
complex as ADASUVE. We appreciate the efforts that Teva has
made to date and are looking forward to continuing to build the
ADASUVE brand," said Thomas B. King,
Alexza President and CEO. "We
remain confident in ADASUVE's long-term commercial prospects and
plan to work with Teva to effect a smooth transition. It is
our intention to work diligently in 2016 to identify a new U.S.
commercial partner for ADASUVE."
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 is
currently available in 20 countries, 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 current 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 to effectively and profitably commercialize
ADASUVE, Alexza's ability to secure a new U.S. commercial partner
for ADASUVE and the terms of any such partnership, 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, 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.
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SOURCE Alexza Pharmaceuticals, Inc.