Alexza Announces Conference Call to Discuss Agreement with Teva to Market
ADASUVE® in the U.S.
Call Scheduled Today for 9:00 a.m. Eastern Time
MOUNTAIN VIEW, Calif., May 8, 2013
MOUNTAIN VIEW, Calif., May 8, 2013 /PRNewswire/ -- Alexza Pharmaceuticals,
Inc. (NASDAQ: ALXA) announced today that they have entered into an exclusive
U.S. license and supply agreement with Teva Pharmaceutical Industries Ltd
(NYSE: TEVA) for ADASUVE^® (Staccato^® loxapine). Alexza will be hosting a
conference call to discuss this transaction at 9:00 a.m. Eastern Time.
Conference Call Information
Analysts and investors can participate in the conference call by dialing
888-679-8018. International callers may access the live call by dialing
+1-617-213-4845. The reference number to enter the call is 57873523.
To access the conference call via the Internet, go to www.alexza.com, under
the "Investor Relations" link. Please join the call at least 15 minutes prior
to the start of the call to ensure time for any software downloads that may be
required. Interested parties may also pre-register to avoid pre-call delays
The replay of the conference call may be accessed via the Internet, at
www.alexza.com, or via telephone at 888-286-8010 for domestic callers or
+1-617-801-6888 for international callers. The reference number for the
replay of the call is 37072348. A replay of the call will be available for
two weeks following the event.
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, including agitation, acute repetitive
seizures and insomnia. Alexza's products are based on the Staccato^® system,
a hand-held inhaler that is designed to deliver a drug aerosol to the deep
lung, providing rapid systemic delivery and therapeutic onset, in a simple,
ADASUVE (Staccato loxapine), Alexza's first approved product, was approved by
the U.S. Food and Drug Administration in December 2012 and by the European
Medicines Agency in February 2013. Teva Pharmaceutical USA Inc. is Alexza's
commercial partner for ADASUVE in the U.S. Grupo Ferrer Internacional, S.A.
is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia
and the Commonwealth of Independent States countries.
For more information about Alexza, the Staccato system technology or the
Company's development programs, please visit www.alexza.com. For more
information about ADASUVE, please visit www.adasuve.com.
ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals,
ADASUVE Partial Prescribing Information (U.S.)
Please click here for Full Prescribing Information, including Boxed WARNINGS.
INDICATIONS AND USAGE
ADASUVE is a typical antipsychotic indicated for the acute treatment of
agitation associated with schizophrenia or bipolar I disorder in adults.
Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia
and one in bipolar I disorder.
Limitations of Use: ADASUVE must be administered only in an enrolled
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH
oADASUVE can cause bronchospasm that has the potential to lead to
respiratory distress and respiratory arrest
oADASUVE is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
oAdminister ADASUVE only in an enrolled healthcare facility that has
immediate access on-site to equipment and personnel trained to manage
acute bronchospasm, including advanced airway management (intubation and
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
oElderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. ADASUVE is not
approved for the treatment of patients with dementia-related psychosis
ADASUVE is contraindicated in patients with the following:
oCurrent diagnosis or history of asthma, chronic obstructive pulmonary
disease (COPD), or other lung disease associated with bronchospasm
oAcute respiratory signs / symptoms (e.g., wheezing)
oCurrent use of medications to treat airways disease, such as asthma or
oHistory of bronchospasm following ADASUVE treatment
oKnown hypersensitivity to loxapine and amoxapine
WARNINGS AND PRECAUTIONS:
oNeuroleptic Malignant Syndrome: May develop in patients treated with
antipsychotic drugs. Discontinue treatment
oHypotension and Syncope: Use with caution in patients with known
cardiovascular or cerebrovascular disease
oSeizure: Use with caution in patients with a history of seizures or with
conditions that lower the seizure threshold
oPotential for Cognitive and Motor Impairment: Use caution when driving or
oCerebrovascular Adverse Reactions: Increased incidence of stroke and
transient ischemic attack in elderly patients with dementia-related
psychosis treated with antipsychotic drugs
The most common adverse reactions (incidence ≥ 2% and greater than placebo) in
clinical studies in patients with agitation treated with ADASUVE were
dysgeusia, sedation, throat irritation.
Safe Harbor Statement
This news release and the planned conference call will contain 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, 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, 2012
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.
SOURCE Alexza Pharmaceuticals, Inc.
Contact: BCC Partners, Karen L. Bergman and Michelle Corral, +1-650-575-1509
or +1-415-794-8662, email@example.com or firstname.lastname@example.org
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