(ALXA) Diario Medico Names ADASUVE® in its “Best Ideas of 2014”

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Dec. 11, 2014  — Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A. (Ferrer) announced today that the Spanish-based publication Diario Medico included ADASUVE^® (Staccato^® loxapine) in its “Best Ideas of 2014” awards.  The Best Ideas awards by Diario Medico acknowledge the daily work of persons, institutions or enterprises that contributed to the improvement of medicine, healthcare, and public health during the previous year.  Ferrer is Alexza’s commercial partner for ADASUVE in the European Union, Latin America, and the Commonwealth of Independent States countries.

“This award recognizes the innovation that is ADASUVE and its contribution to the improvement in the quality of life of the patients suffering from bipolar disorder and schizophrenia,” said Antoni Villaro, Chief Operating Officer of Ferrer.  “We continue to hear from doctors and nurses who are using ADASUVE that they are impressed with ADASUVE’s strong efficacy and rapid onset as well as its potential to change the practice in treating these patients.”

“The Diario Medico Best Idea award exemplifies the vision of our founder, Dr. Alejandro Zaffaroni.  He believed we could improve patient therapies with our Staccato^® technology, where drugs are quickly vaporized to deliver alternative therapeutic options for a variety of acute and intermittent conditions,” said Thomas B. King, President and Chief Executive Officer of Alexza Pharmaceuticals.  “We believe ADASUVE’s combination of an effective drug in our Staccato system can be a model for changing other suboptimal standard-of-care regimens.  Our primary focus in the near term remains supporting the global commercialization of ADASUVE, and we also look forward to building on the success of this first approved product and developing other product candidates in the coming years.”

About Staccato^®
Staccato technology is a novel form of inhaled drug delivery that is uniquely suited for conditions requiring speed of therapeutic effect, reliable dosing, and ease of use.  Staccato system single-dose device houses a heat package comprising a stainless steel substrate, which is coated with excipient-free drug – the system requires no excipients or pharmaceutical stabilizers.  With a single breath by the patient, the system rapidly actuates to form a drug aerosol of consistent sized particles between one and three microns.  At this size, the particles are rapidly absorbed in the deep lung, ensuring rapid uptake in the bloodstream and rapid onset of pharmacological effect.

About ADASUVE (Staccato loxapine)
ADASUVE combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic medicinal product.  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 EU 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.

Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder¹.  Agitation is a common symptom for these patients², characterized by feelings of distress, anxiety, and loss of control.

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, is based on the Staccato technology, and has been approved for sale by the U.S. Food and Drug Administration, the European Commission, and in several Latin American countries.

Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., 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.   Wittchen H.U., et al., 2011. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21, 655-679.

2.   Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation).