MOUNTAIN VIEW, Calif.,
Feb. 24, 2016 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has
reacquired U.S. commercial rights for ADASUVE®
(loxapine) inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical
Industries Ltd. Alexza and Teva have also restructured the
obligations under the outstanding note from Teva. In
conjunction with the reacquisition of U.S. ADASUVE rights, Alexza
and Teva have completed a transition agreement, which is intended
to provide continued availability of ADASUVE by Alexza to patients
and health care providers.
Terms of the ADASUVE Product Reacquisition
- The ADASUVE NDA and related regulatory filings will be
transferred to Alexza. Alexza will assume responsibility for all
regulatory activities related to ADASUVE in the U.S.
- Responsibility for the ADASUVE U.S. Phase 4 study, product
pharmacovigilance, medical services, and REMS compliance will be
transferred to Alexza over the course of the next 90 days. Alexza
intends to continue these activities with the relationships and
agreements established by Teva.
- Teva will transfer to Alexza product inventory, promotional
materials, and other ADASUVE trade materials. Alexza will have the
ability to promote and distribute ADASUVE, under the currently
approved label and labeling for up to 12 months, including to
existing customers, subject to certain limitations.
- Alexza will take over responsibility for administering the
ongoing investigator sponsored studies and the directed research
grant.
Terms of the Teva Note Restructuring
- Alexza will issue approximately 2.17 million shares to Teva as
consideration for the reduction in the Teva note by $5 million of principal and forgiveness of all
accrued and unpaid interest. After the share issuance, Teva will
own approximately 9.9% of Alexza's outstanding common stock.
- The remaining Teva note balance will become payable in the
first calendar year following the calendar year in which the
aggregate annual net sales of ADASUVE and any other
Staccato-based products first reach $50 million in the U.S. After the U.S. sales
reach this threshold, the $20 million
note balance will be due and will be payable in four consecutive
annual payments of $5 million
each.
"We appreciate the efforts that Teva has made to date and are
looking forward to continuing to build the ADASUVE brand. We
remain confident in ADASUVE's long-term commercial prospects and
plan to continue to work with Teva to effect a smooth transition,"
said Thomas B. King, Alexza President and CEO. "Moving forward,
Alexza will have primary responsibility for the immediate
commercial aspects of ADASUVE and is working diligently 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. The product is approved
for sale by the U.S. Food and Drug Administration, the European
Commission and in several Latin American countries. 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
adequacy of the Company's capital to support the Company's
operations, the ability of Alexza and Ferrer 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, 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.