MOUNTAIN VIEW, Calif.,
June 18, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced
that it has updated and amended its ADASUVE®
(Staccato® loxapine) commercial partnerships with
Grupo Ferrer Internacional, S.A.
(Ferrer) and Teva Pharmaceutical Industries Ltd. (Teva).
Ferrer is Alexza's commercial partner for ADASUVE in the European
Union, Latin America, the
Commonwealth of Independent States and other countries in
Europe. Teva is Alexza's commercial partner for ADASUVE in
the United States.
As previously announced in May
2015, Alexza analyzed various initiatives that could reduce
manufacturing costs, including supply chain requirements, to make
global production more efficient and cost-effective. As a
result of this analysis, Alexza plans to complete ADASUVE
commercial production for Ferrer and Teva pending orders in the
third quarter of 2015, and then will suspend ADASUVE commercial
production operations. The primary goal of this action is to
reduce Alexza's underutilized manufacturing capacity, overhead
expenses and related costs, while fulfilling the supply
requirements of its commercial partners.
In connection with the modification to the manufacturing
obligations by Alexza, which also included evaluation of internal
and possible external (third party) manufacturing capabilities or
alternatives, the companies have updated and amended their
commercial partnerships.
"The comprehensive amendments we have completed allow for
continued commercialization of ADASUVE while providing flexibility
to reflect market learnings during the launch of the product," said
Thomas B. King, President and CEO of
Alexza Pharmaceuticals. "We believe the sales during the
global launch of ADASUVE do not reflect the clinical benefits
ADASUVE can convey to patients, and we remain confident in
ADASUVE's long-term commercial prospects. Early feedback from
physicians and patients corroborate the positive clinical profile
we observed with ADASUVE during its clinical development."
King continued, "We believe we are making solid decisions
regarding how to run our business for the future and are making
strategic changes to our business model. Amending our
agreements with Ferrer and Teva will allow us to reduce the costs
of producing ADASUVE and eliminate the costs associated with some
of the EU post-approval commitments, with the overall goal of
substantially reducing our cash burn rate."
Ferrer and Alexza Agreement Amendment
- Alexza's Manufacturing Obligations: Alexza and Ferrer
have agreed to identify more suitable long-term solutions for
future ADASUVE manufacturing. Alexza's current ADASUVE
manufacturing obligations are to be suspended for a period of time.
During the manufacturing suspension period, Alexza and Ferrer will
evaluate internal and possible external (third party) manufacturing
capabilities.
- Ferrer's Right to Manufacture: Ferrer and Alexza have
agreed that Ferrer will have the option to manufacture ADASUVE at
its facilities. If Ferrer chooses to exercise its option, it will
be granted ADASUVE manufacturing rights for the Ferrer territories,
including an option to manufacture certain additional
Staccato products for the Ferrer territories.
- MAA Transfer to Ferrer: Alexza will transfer the EU
Marketing authorization for ADASUVE (MAA), to Ferrer. The MAA
transfer includes the responsibilities for the ongoing
post-approval clinical studies (the PASS and DUS studies), a future
Phase 3 study in adolescents, as well as ongoing pharmacovigilance
responsibilities.
- Milestone Payment Elimination: In consideration for
taking on additional responsibilities, the specific milestone
payments for first commercial sales in Russia, Brazil and Turkey have been eliminated.
- Territory and Technology Expansion: Ferrer will gain
ADASUVE registration and commercialization rights for Middle East and North Africa (MENA), Korea, Philippines, and Thailand territories. In addition, Ferrer will
have the option to develop and commercialize additional
Staccato products for the Ferrer territories, with certain
rights outside of the current Ferrer territory, in consideration
for royalties to Alexza.
Teva and Alexza Agreement Amendment
- Alexza's Manufacturing Obligations: Alexza and Teva have
agreed to identify more suitable long-term solutions for future
ADASUVE manufacturing. Alexza's current ADASUVE manufacturing
obligations are to be suspended for a period of time. During the
manufacturing suspension period, Alexza and Teva will evaluate
internal and possible external (third party) manufacturing
capabilities.
- Modification of Teva's Commercial Obligations: Alexza
and Teva have agreed to adjust certain of Teva's commercial
diligence obligations related to ADASUVE for a period of time. Teva
will continue to use commercially reasonable efforts to
commercialize ADASUVE in the U.S., be responsible for all related
regulatory and clinical activities, and will continue to be
responsible for royalties and milestone payments on the U.S. sales
of ADASUVE.
- Modification to Teva note: The maturity note will be
extended for a time equal to the duration of manufacturing
suspension period. No interest will accrue on the Teva note
during the manufacturing suspension period.
During the manufacturing suspension period Alexza plans to work
with its commercial partners to find the most efficient path for
future ADASUVE manufacturing and assure ADASUVE supplies for
current and new markets.
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.
ADASUVE is currently available in the
United States, sixteen EU member countries, one Latin
American country, and is also approved in eight countries in
Latin America.
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®, Alexza's first commercial product, is based
on the Staccato system 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, MENA, Korea, Philippines, and Thailand territories.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc. For more
information, 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 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:
- 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.