MOUNTAIN VIEW, Calif.,
Oct. 9, 2014 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today provided
an update on the U.S. commercial progress with ADASUVE®
(loxapine) inhalation powder (Staccato® loxapine).
Teva Pharmaceutical Industries Ltd. is Alexza's commercial partner
for ADASUVE in the United States.
Teva and Alexza announced the commencement of the U.S. launch
of ADASUVE in March 2014.
"During the third quarter, we shipped 32,278 units of ADASUVE to
Teva, completing the initial product inventory stocking of ADASUVE
for the U.S. markets. Initial product sales will be sourced
from this inventory stocking," said Robert
A. Lippe, Executive Vice President and Chief Operations
Officer of Alexza. "We do not expect to ship any additional
product to Teva until early 2015. As the U.S. distribution
channel inventory is depleted by product sales, we plan to continue
product shipments to address product demand and sales."
"It is early in the U.S. ADASUVE launch. All hospital
products go through the required processes for a product to be
stocked in the hospital and then used by physicians," said
Thomas B. King, President and CEO of
Alexza. "These processes are no different for ADASUVE.
With five quarters of EU sales experience and two quarters of U.S.
sales experience, we and our commercial partners are seeing what we
view as positive progress in the important measures of the product
launch process."
Alexza provided the following additional updates on ADASUVE in
the U.S.:
- Alexza shipped 32,278 units in the third quarter, completing
the ADASUVE initial product inventory stocking. Total shipments to
Teva have been 83,404 units to date, in order to fill the
distribution network from which to stock hospital pharmacies and
support sales.
- Alexza is seeing early launch trends in measureable activities
on a monthly basis that are similar to those observed early in the
European launches. Alexza anticipates a similar uptake trajectory
in the U.S., characterized by steady growth in the number of
hospitals stocking ADASUVE, which then results in increasing levels
of product sales as a result of product use at each individual
hospital.
- Alexza has completed manufacturing process validation for an
increased production batch size of 10,000 units. The successful
completion of these activities allows for greater flexibility in
the production scheduling and planning for U.S. ADASUVE production,
and is part of the continued work on longer-term reduction of cost
of goods for ADASUVE.
- Teva is responsible for U.S. post-approval clinical studies.
ADASUVE is being studied in a non-randomized, open-label,
multicenter Phase 1 study to assess the safety and pharmacokinetics
of the product at doses of 2.5, 5, or 10 mg in children and
adolescents. This study has been initiated. Additional information
about this clinical trial can be found at clinicaltrials.gov.
About Teva - Alexza Agreement
Teva licensed the U.S. commercial rights to ADASUVE in May 2013 from Alexza. Under the terms of
the license and supply agreement, Teva is responsible for all U.S.
commercial and clinical activities for ADASUVE, including U.S.
post-approval clinical studies. Alexza is responsible for
manufacturing and supplying ADASUVE to Teva for commercial sales
and clinical trials. Alexza is eligible to receive tiered
royalty payments based on net commercial sales of ADASUVE, as well
as certain milestone payments, based upon successful completion of
the ADASUVE post-approval studies in the U.S and the achievement of
net sales targets.
About ADASUVE (Staccato® loxapine)
ADASUVE is the first and only inhalation therapy for the acute
treatment of agitation associated with schizophrenia or bipolar I
disorder in adults. The US marketing authorization for
ADASUVE requires that patients are screened and monitored for
respiratory events as part of the risk and mitigation
strategy. It also requires that ADASUVE be administered only
in a hospital setting under the supervision of a healthcare
professional. In the United
States, approximately 2.4 million adults have schizophrenia
and approximately 5.7 million adults have bipolar disorder.
More than 90% of patients with schizophrenia or bipolar disorder
will experience agitation in their lifetimes1. For
the full prescribing information including boxed warnings for the
U.S., please visit www.adasuve.com.
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.
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 and it has been
approved for sale by the U.S. Food and Drug
Administration, the European Commission and in Guatemala and Chile. 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 for 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.
1 Alexza - data on file.
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SOURCE Alexza Pharmaceuticals, Inc.