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alexza pharmaceuticals inc (ALXA) Details

Alexza Pharmaceuticals, Inc., a pharmaceutical company, focuses on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions worldwide. The company’s product candidates are based on a proprietary technology, the Staccato system, which vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Its lead product, ADASUVE (Staccato loxapine) inhalation powder for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The company’s product candidate in development, AZ-002 (Staccato alprazolam), is indicated for the treatment of acute repetitive seizures. It has strategic collaborations with Grupo Ferrer Internacional S.A. and Teva Pharmaceuticals USA, Inc. The company was formerly known as Alexza Molecular Delivery Corporation and changed its name to Alexza Pharmaceuticals, Inc. in July 2005. Alexza Pharmaceuticals, Inc. was incorporated in 2000 and is based in Mountain View, California.

90 Employees
Last Reported Date: 03/25/14
Founded in 2000

alexza pharmaceuticals inc (ALXA) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $526.0K
Compensation as of Fiscal Year 2013.

alexza pharmaceuticals inc (ALXA) Key Developments

Alexza Pharmaceuticals Inc. Announces Resignation of James V. Cassella as its Executive Vice President, Research and Development, and Chief Scientific Officer

Alexza Pharmaceuticals Inc. announced that James V. Cassella's employment with the company would be ending effective as of January 30, 2015. Dr. Cassella is currently the company's Executive Vice President, Research and Development, and Chief Scientific Officer. Cassella's resignation was not the result of any disagreement with the company on any matter relating to its operations, policies or practices, or regarding the general direction of the company.

Alexza Pharmaceuticals, Inc. Initiates Phase 2A Study of AZ-002 (Staccato® alprazolam) in Epilepsy Patients

Alexza Pharmaceuticals Inc. announced that it has initiated a Phase 2a study of AZ-002 (Staccato® alprazolam), which is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS). ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs. Epilepsy, a disorder of recurrent seizures, affects approximately 2.5 million Americans, making it the third most common neurological disorder in the United States. ARS refers to seizures that are serial, clustered or crescendo, and ones that are distinct from the patient's usual seizure pattern. Typically there is recovery between the seizures in the cluster1. Among the implications of ARS are concerns for patient safety. Seizure effects generally correlate directly with seizure duration. Prolonged or recurrent seizure activity persisting for 30 minutes or more may result in serious injury, health impacts or death. If left untreated, ARS has been reported to evolve into status epilepticus, a life-threatening condition in which the brain is in a state of persistent seizure which has a mortality rate of 3% in children and 26% in adults.2 Benzodiazepines are considered to be medications of first choice for the treatment of ARS. The most immediate treatment for out-of-hospital care and the only U.S. Food and Drug Administration-approved product for acute repetitive seizures is rectal diazepam gel. This treatment may produce central nervous system depression. Oral, buccal, and sublingual benzodiazepines (lorazepam, diazepam), which are not approved for patients with ARS, are sometimes used for treatment, but only if the risk of aspiration is not a concern and it is recognized that the absorption time will be increased. Nasal benzodiazepine products, available in some countries, are not yet available in the United States. Intravenous benzodiazepines are rapidly acting, but must be administered by a healthcare professional in a medical facility. The ability to treat a patient quickly is clinically imperative to avoid the epilepsy becoming status epilepticus or causing other serious complications3. Alexza believes that a product that can be administered easily in the home setting to effectively treat ARS may result in avoiding a trip to the hospital for treatment or diminish the use of the rectal formulation of diazepam. AZ-002 could be administered after the first seizure in a cluster, with the aim of preventing further seizures. The caregiver could provide dosing assistance between seizures. The product could also be used in a healthcare facility, thus avoiding the use of an IV or a rectal formulation of a benzodiazepine. Alexza's AZ-002 Phase 2a study is an in-clinic, randomized, placebo-controlled, double-blind evaluation of patients with epilepsy using the intermittent photo-stimulation model. The primary aim of this study is to assess the safety and the pharmacodynamic electroencephalographic effects of a single dose of AZ-002 at different dose strengths vs. placebo. Data from this clinical trial are expected to serve as the basis for dose selection in potential future efficacy and safety clinical studies and will be collected from three clinical trial sites. While there are not firm incidence and prevalence numbers in the literature, there are estimated to be about 150,000 people with ARS in the United States, which could make AZ-002 eligible for orphan product status.

Alexza Pharmaceuticals, Inc. Amends Commercial Manufacturing and Supply Agreement with Autoliv ASP Inc

Alexza Pharmaceuticals, Inc. announced that it amended its commercial Manufacturing and Supply Agreement with Autoliv ASP Inc. The amendment to the Supply Agreement between Alexza and Autoliv, signed on December 12, 2014, updates certain terms of prior agreements between the companies. The Amendment states that the letter of termination received by Alexza in October 2013 is null, and that the parties are extending the agreement through 2018. In addition, Alexza has the right to engage a second source supplier and implement a manufacturing line transfer from Autoliv to manufacture and supply the chemical heat packages to Alexza or its licensees.


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