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Alexza Pharmaceuticals,
Inc.
today announced that the company's commercial partner
Grupo Ferrer Internacional, S.A. has initiated sales of ADASUVE^® inhalation
powder, pre-dispensed (Staccato^® Loxapine) in the European Union ("EU").
ADASUVE is now available in Germany. The first sale and shipment of product
by Ferrer triggers a $1.25 million milestone payment to Alexza, pursuant to
the Company's collaboration agreement with Ferrer.
"This launch represents the first commercial sale of ADASUVE in the world, and
marks the culmination of many years of dedicated effort and rigorous clinical
development. I am incredibly proud of the efforts by the Alexza team and our
partner Ferrer in bringing ADASUVE to physicians in the EU for use in their
treatment of agitated patients with schizophrenia or bipolar disorder," said
Thomas B. King, President and CEO of Alexza. "The initial launch of ADASUVE
in Germany, followed by Ferrer's planned commercial roll out across the EU, is
a key milestone for Alexza."
Alexza received marketing authorization for ADASUVE from the European
Commission in February 2013. ADASUVE is the first inhalation therapy for the
rapid control of mild-to-moderate agitation in adult patients with
schizophrenia or bipolar disorder authorized to be placed on the market in the
EU. The 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 also be available
for treatment of possible severe respiratory side-effects, such as
bronchospasm.
"Alexza and Ferrer's effective cooperation has enabled a product launch of
ADASUVE in an admirably short time following the EU approval in February
2013," said Antoni Villaro, Chief Operating Officer of Ferrer. "ADASUVE is an
important strategic product for Ferrer and we are excited to be introducing
ADASUVE to the EU psychiatric and hospital treatment community."
Under the terms of the collaboration agreement between Alexza and Ferrer,
which was announced in October 2011, Alexza is the exclusive supplier of
ADASUVE, responsible for all aspects of manufacture of the product. Alexza
began manufacturing launch quantities of the product for the EU in the second
quarter of 2013 at its Mountain View, California facility. The commercial
product was shipped to Ferrer in June 2013, and Ferrer completed EU product
quality control release and final packaging in preparation for the planned
third quarter launch. Ferrer is expected to launch ADASUVE in additional EU
countries before year-end and will continue the EU launch into 2014.
Alexza and Ferrer estimate that as many as 8 million adults in the EU alone
suffer from schizophrenia or bipolar disorder^1. Agitation is a common
symptom for these patients^2, characterized by feelings of distress, anxiety
and loss of control.
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