Teva and Alexza Announce Teva's License to Market ADASUVE® in the U.S.

    Teva and Alexza Announce Teva's License to Market ADASUVE® in the U.S.

Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute
treatment of agitation associated with schizophrenia and bipolar disorder

PR Newswire

NORTH WALES, Pa. and MOUNTAIN VIEW, Calif., May 8, 2013

NORTH WALES, Pa. andMOUNTAIN VIEW, Calif., May 8, 2013 /PRNewswire/ --Teva
Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd
(NYSE: TEVA), and Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today
that the companies have entered into an exclusive U.S. license and supply
agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute
treatment of agitation associated with schizophrenia or bipolar I disorder in
adults. Teva will be responsible for all U.S. commercial and clinical
activities for ADASUVE, including U.S. post-approval clinical studies, and has
gained rights to conduct additional clinical trials of ADASUVE for potential
new indications in neurological disorders. Alexza will be responsible for
manufacturing and supplying ADASUVE to Teva for commercial sales and clinical

"Approximately 4 to 5 million patients with bipolar I disorder or
schizophrenia in the U.S. experience and seek treatment for agitation
episodes," stated Larry Downey, President, North America Specialty Medicines.
"This agreement reflects our business development strategy to pursue
opportunities in our core therapeutic areas where we can apply our expertise
and experience to enhance treatment options for patients. ADASUVE is a
compelling addition to our U.S. Specialty Medicines portfolio, and we look
forward to working with Alexza as we commercialize this important treatment

"Teva brings an established commercial presence in hospital and psychiatric
markets. ADASUVE is approved to address agitation episodes in the
hospital-setting, providing a fast-acting, non-coercive treatment option to
patients with schizophrenia and bipolar I disorder," said Thomas B. King,
Alexza President and CEO. "Teva has considerable strength and market presence
with the Teva Select Brands group, and we are confident of their ability to
deliver commercial success for this important new product."

Under the terms of the license and supply agreement, Alexza will receive an
upfront cash payment of $40 million and is eligible to receive up to $195
million in additional milestone payments, based upon successful completion of
the ADASUVE post-approval studies in the U.S. and achieving net sales targets.
In addition, Teva will make tiered, royalty payments based on net commercial
sales of ADASUVE.

Teva also will make available up to $25 million to Alexza via a five-year
convertible note and agreement to lend, which Alexza may access to support its
ADASUVE activities. Alexza may prepay up to 50 percent of the outstanding
amount at any time prior to maturity. Teva may convert, at maturity, all or a
portion of the then outstanding amount under the note into equity of Alexza.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic drugs as
well as innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading generic
drug maker, with a global product portfolio of more than 1,000 molecules and a
direct presence in about 60 countries. Teva's branded businesses focus on
CNS, oncology, pain, respiratory and women's health therapeutic areas as well
as biologics. Teva currently employs approximately 46,000 people around the
world and reached $20.3 billion in net revenues in 2012.

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,
non-invasive manner.

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 For more
information about ADASUVE, please visit

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.


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
healthcare facility.




  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
    mechanical ventilation)

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


  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
    operating machinery
  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.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:

This release contains forward-looking statements, which express the current
beliefs and expectations of management. Such statements are based on
management's current beliefs and expectations and involve a number of known
and unknown risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to: our ability to develop and
commercialize additional pharmaceutical products, competition for our
innovative products, especially Copaxone^® (including competition from
innovative orally-administered alternatives, as well as from potential
purported generic equivalents), competition for our generic products
(including from other pharmaceutical companies and as a result of increased
governmental pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our innovative R&D
efforts, the effectiveness of our patents and other protections for innovative
products, decreasing opportunities to obtain U.S. market exclusivity for
significant new generic products, our ability to identify, consummate and
successfully integrate acquisitions, the effects of increased leverage as a
result of recent acquisitions, the extent to which any manufacturing or
quality control problems damage our reputation for high quality production and
require costly remediation, our potential exposure to product liability claims
to the extent not covered by insurance, increased government scrutiny in both
the U.S. and Europe of our agreements with brand companies, potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation, including that relating to the generic version
of Protonix^®, our exposure to currency fluctuations and restrictions as well
as credit risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with complex
Medicare and Medicaid reporting and payment obligations, governmental
investigations into sales and marketing practices (particularly for our
specialty pharmaceutical products), uncertainties surrounding the legislative
and regulatory pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, major hostilities or acts of terrorism on our
significant worldwide operations, interruptions in our supply chain or
problems with our information technology systems that adversely affect our
complex manufacturing processes, any failure to retain key personnel or to
attract additional executive and managerial talent, the impact of continuing
consolidation of our distributors and customers, variations in patent laws
that may adversely affect our ability to manufacture our products in the most
efficient manner, potentially significant impairments of intangible assets and
goodwill, potential increases in tax liabilities, the termination or
expiration of governmental programs or tax benefits, environmental risks and
other factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31, 2012 and in our other filings with the U.S. Securities
and Exchange Commission. Forward-looking statements speak only as of the date
on which they are made and the Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new information,
future events or otherwise.

Alexza's 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: Teva IR Contacts, Kevin C. Mannix,, (215)
591-8912; Teva PR Contacts, Denise Bradley,,
(215) 591-8974; Alexza IR/PR Contacts, Karen L. Bergman or Michelle Corral,,, (650) 575-1509, (415)
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