Alexza Pharmaceuticals Announces the Launch of ADASUVE® (inhalation powder, loxapine) in Guatemala

MOUNTAIN VIEW, Calif., Aug. 8, 2014 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that ADASUVE^® inhalation powder, pre-dispensed (loxapine) is now available in Guatemala.  This approval represents the first ADASUVE approval in Latin America for Ferrer and Alexza.  Ferrer is Alexza's commercial partner for ADASUVE in the EU, Latin America and Commonwealth of Independent States countries.  

Ferrer introduced ADASUVE during a psychiatric medical meeting in Guatemala, hosted by Congreso National de Psiquiatria de Guatemala, held in Guatemala City, August 7 - 8, 2014.  During the meeting, Ferrer hosted a symposium on agitation, entitled "ADASUVE: una innovacion terapeutica en el tratamiento de la agitacion" or "ADASUVE: A therapeutic innovation in the treatment of agitation."

"Ferrer is making strong progress in securing approvals for ADASUVE," said Thomas B. King, President and CEO of Alexza.  "We are pleased with their progress, as the Guatemala approval represents Ferrer's first non-EU submission and approval of ADASUVE."

"Launching ADASUVE in the first Latin American country is an important milestone in our collaboration with Alexza and our commercial plan for ADASUVE," said Antoni Villaro, Chief Operating Officer of Ferrer.  "We believe ADASUVE provides an important new option for clinicians who treat patients with agitation associated with schizophrenia or bipolar disorder." 

ADASUVE is the first and only inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.  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 be available for treatment of possible severe respiratory side effects, such as bronchospasm.

Ferrer estimates that approximately 10 million adults in Latin America suffer from schizophrenia or bipolar disorder¹.  Agitation is a common symptom for these patients², characterized by feelings of distress, anxiety, and loss of control. 

Alexza Pharmaceuticals, Inc. and Ferrer are parties to the collaboration agreement for ADASUVE pursuant to which Alexza, as the exclusive supplier of ADASUVE, is responsible for all aspects of manufacture of the product.  Ferrer is expected to launch ADASUVE in additional EU and Latin American countries in 2014 and 2015.

About ADASUVE (Staccato^® loxapine)
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.

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 most recently in Guatemala.  Teva Pharmaceuticals USA, Inc. 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.

The authorization for ADASUVE in the EU differs from that in the United States, with respect to the indication statement, dose regimen, available dose strengths, and risk mitigation and management plans. For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU, please visit the EMA website.  For the full prescribing information including boxed warnings for the U.S., please visit www.adasuve.com. 

About Ferrer
Founded in 1959, Ferrer is a privately-held European R&D-based pharmaceutical company headquartered in Barcelona.  It is active in the pharmaceutical, health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States.  In total, Ferrer's human healthcare products are commercialized in more than 90 countries, through 27 international affiliates (including joint ventures) and 70 partners and distributors.

Ferrer carries out activities throughout the full pharmaceutical value chain, from R&D to international marketing, including fine chemical development and the manufacturing of both raw materials and finished pharmaceuticals.  Its research centers in Spain and Germany, and manufacturing sites in Europe and Latin America cover the pharmaceutical, diagnostics, vaccine, fine chemical, food and feed sectors.  For more information, visit www.ferrer.com.

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 most recently in Guatemala.  Teva Pharmaceuticals USA, Inc. 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 of Alexza and its partners, 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.

References:

1. Kohn R, Levav I, Caldas de Almeida JM, Vicente B, Andrade L, Caraveo-Anduaga JJ, Saxena S, Saraceno B. Los trastornos mentales en America Latina y el Caribe: asunto prioritario para la salud publica. Re Panam Salud Publica. 2005;18(4/5):229-40.
2. Alexza data on file (primary market research among caregivers of patients with schizophrenia and bipolar patients).

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SOURCE Alexza Pharmaceuticals, Inc.