With the ADASUVE NDA approval, Alexza also has several post-approval requirements, including a large observational clinical trial designed to gather patient safety data based on the real-world use of ADASUVE, as well as a clinical program addressing the safety and efficacy of ADASUVE in agitated adolescent patients.About Agitation Associated with Schizophrenia and Bipolar I DisorderAgitation is a serious medical problem that can present in a number of psychiatric disorders, including schizophrenia and bipolar I disorder. Of the estimated 3.2 million patients treated for schizophrenia or bipolar I disorder in the U.S. 3, about 90% suffer from agitation in their lifetime 4, due to the natural course of underlying disease or non-compliance with chronic medication. Patients average 11 to 12 episodes of agitation each year 5. Agitation episodes may escalate unpredictably and, in some cases, necessitate chemical or physical restraint to relieve the individual's distress and to protect care providers and others in close proximity. Rapid, effective and safe intervention is key to returning the agitated person to a less agitated state. About Alexza Pharmaceuticals, Inc.Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, is designed for rapid systemic drug delivery through deep lung inhalation. (Click here to see an animation of how the Staccato system works.) ADASUVE ® ( Staccato loxapine) is Alexza's lead therapeutic program. Grupo Ferrer Internacional, S.A is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Alexza filed its ADASUVE Marketing Authorization Application with the European Medicines Agency (EMA) in October 2011. In December 2012, Alexza received a positive opinion from the EMA's Committee for Medicinal Products for Human Use recommending the approval of ADASUVE in the European Union for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. The European Commission is now expected to grant marketing authorization for ADASUVE in all 27 European Union Member States, plus Iceland, Lichtenstein and Norway. A decision is expected from the European Commission in the first quarter of 2013. For more information about Alexza, the Staccato system technology or the Company's development programs, please visit www.alexza.com. For more information about ADASUVE, please visit www.adasuve.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 for Alexza to effectively and profitably commercialize ADASUVE in the US, the impact and risks of the ADASUVE post-marketing studies and Risk Evaluation and Mitigation Strategy (REMs) on the commercialization 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, 2011 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:
- Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8.
- Kwentus J, Riesenberg RA, Marandi M, Manning RA, Allen MH, Fishman RS, Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord. 2012 Feb;14(1):31-40.
- Alexza data on file (Calculation: from NIMH prevalence; Saha 2005; Merikangas K. Lifetime and 12-month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007. 64(5):543-552.)
- Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation))
- Alexza data on file (primary market research among caregivers of patients with schizophrenia (have an average of 12 agitation episodes per year) and bipolar patients (have an average of 11 agitation episodes per year))