UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 22, 2015
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-51820 |
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77-0567768 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
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Alexza Pharmaceuticals, Inc.
2091 Stierlin Court
Mountain View, California |
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94043 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (650) 944-7000
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Section 8 Other Events
Item 8.01. Other Events.
On January 22, 2015,
Alexza Pharmaceuticals, Inc. (Alexza or the Company) announced that it had initiated a Phase 2a study of AZ-002 (Staccato® alprazolam), which is being developed for the
management of epilepsy 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. The press
release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
Section 9 Financial
Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
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Description |
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99.1 |
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Press Release titled Alexza Pharmaceuticals Initiates Phase 2a Study of AZ-002 (Staccato® alprazolam) in Epilepsy Patients dated January 22, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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ALEXZA PHARMACEUTICALS, INC. |
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Date: January 22, 2015 |
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By: |
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/s/ Thomas B. King |
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Thomas B. King
President and Chief Executive Officer |
INDEX TO EXHIBITS
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Exhibit Number |
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Description |
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99.1 |
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Press Release titled Alexza Pharmaceuticals Initiates Phase 2a Study of AZ-002 (Staccato® alprazolam) in Epilepsy Patients dated January 22, 2015. |
Exhibit 99.1
NEWS RELEASE - for immediate release
Alexza Pharmaceuticals Initiates Phase 2a Study of AZ-002
(Staccato® alprazolam) in Epilepsy Patients
Mountain View, California - January 22, 2015 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today 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.
Our team has been working with some
of the leading opinion leaders in the field of epilepsy to finalize our development strategy for AZ-002, said James V. Cassella, PhD, Executive Vice President, Research and Development, and Chief Scientific Officer of Alexza. We
believe that AZ-002, if approved, could greatly benefit epilepsy patients who experience seizure emergencies like ARS.
Dr. Cassella continued,
In previous clinical studies where we have dosed more than 100 subjects, Staccato alprazolam demonstrated excellent dose-proportionality, exhibited a median Tmax (time to peak
plasma concentration) of 2 minutes, and was safe and well-tolerated.
Acute Repetitive Seizures (ARS)
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 patients 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. 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.
AZ-002 Study Design
Alexzas 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 150,0004 people with ARS in the United States, which could make AZ-002 eligible for orphan product status.
Alexza expects to announce results from this study in the first half of 2015. More information on this Phase 2a study can be found at
www.clinicaltrials.gov. Alexza owns full development and commercial rights to AZ-002.
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. Alexzas 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.
For more information, visit www.alexza.com.
ADASUVE is Alexzas 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 Alexzas commercial partner for ADASUVE in the United States. Grupo Ferrer Internacional SA is Alexzas commercial partner for ADASUVE in Europe, Latin
America, and the Commonwealth of Independent States countries.
ADASUVE® and Staccato® are registered trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
This press release contains forward-looking statements that involve significant risks and uncertainties. Any statement describing the Companys
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 our 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 Companys capital to support the Companys operations, and the Companys
ability to raise additional funds and the potential terms of such potential financings, whether the Companys financial resources will be sufficient to meet its business objectives and
operational requirements to manufacture ADASUVE and to develop AZ-002, results of studies and trials may not be predictive of the future clinical trial results of AZ-002 or other product candidates, the protection and market exclusivity provided by
the Companys intellectual property for its product candidates, including rights to AZ-002, and the impact of competitive products and technological changes. The Companys 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 Alexzas business are described in additional detail in the Companys Annual
Report on Form 10-K for the year ended December 31, 2013 and the Companys 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.
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CONTACT: |
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Ana Kapor Alexza Pharmaceuticals
Senior Director, Investor Relations and Corporate Communications
650.944.7906 akapor@alexza.com |
Reference:
1. |
Cereghino, JJ., 2007. Identification and treatment of acute repetitive seizures in children and adults |
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Boggs, J., 2004. Mortality Associated with Status Epilepticus |
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Dreifuss, Fritz E., 1998. Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures |