MOUNTAIN VIEW, Calif., May 8, 2013 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today that they have entered into an exclusive U.S. license and supply agreement with Teva Pharmaceutical Industries Ltd (NYSE: TEVA) for ADASUVE ® (Staccato ® loxapine). Alexza will be hosting a conference call to discuss this transaction at 9:00 a.m. Eastern Time.
Conference Call InformationAnalysts and investors can participate in the conference call by dialing 888-679-8018. International callers may access the live call by dialing +1-617-213-4845. The reference number to enter the call is 57873523.
To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link. Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required. Interested parties may also pre-register to avoid pre-call delays at https://www.theconferencingservice.com/prereg/key.process?key=PP7TMEX97.
The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via telephone at 888-286-8010 for domestic callers or +1-617-801-6888 for international callers. The reference number for the replay of the call is 37072348. A replay of the call will be available for two weeks following the event.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, including agitation, acute repetitive seizures and insomnia. Alexza's products are based on the Staccato ® system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. ADASUVE ( Staccato loxapine), Alexza's first approved product, was approved by the U.S. Food and Drug Administration in December 2012 and by the European Medicines Agency in February 2013. Teva Pharmaceutical USA Inc. is Alexza's commercial partner for ADASUVE in the U.S. Grupo Ferrer Internacional, S.A. is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. 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. ADASUVE Partial Prescribing Information (U.S.) Please click here for Full Prescribing Information, including Boxed WARNINGS. INDICATIONS AND USAGE ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder. Limitations of Use: ADASUVE must be administered only in an enrolled healthcare facility. IMPORTANT SAFETY INFORMATION WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. Bronchospasm :
- ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
- ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
- Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation)
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis
- Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm
- Acute respiratory signs / symptoms (e.g., wheezing)
- Current use of medications to treat airways disease, such as asthma or COPD
- History of bronchospasm following ADASUVE treatment
- Known hypersensitivity to loxapine and amoxapine
- Neuroleptic Malignant Syndrome : May develop in patients treated with antipsychotic drugs. Discontinue treatment
- Hypotension and Syncope : Use with caution in patients with known cardiovascular or cerebrovascular disease
- Seizure : Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold
- Potential for Cognitive and Motor Impairment : Use caution when driving or operating machinery
- Cerebrovascular Adverse Reactions : Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs