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): May 3, 2012
ALEXZA PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
000-51820 |
77-0567768 | ||
(State or other jurisdiction | (Commission | (IRS Employer | ||
of incorporation) | File Number) | Identification No.) |
Alexza Pharmaceuticals, Inc. 2091 Stierlin Court Mountain View, California |
94043 | |
(Address of principal executive offices) | (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):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | 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 May 3, 2012, Alexza Pharmaceuticals, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application (NDA) for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg. 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. |
Exhibit Number |
Description | |
99.1 | Press Release titled Alexza Receives Complete Response Letter for ADASUVE NDA, dated May 3, 2012. |
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.
ALEXZA PHARMACEUTICALS, INC. | ||||||
Date: May 3, 2012 | By: | /s/ Thomas B. King | ||||
Thomas B. King | ||||||
President and Chief Executive Officer |
INDEX TO EXHIBITS
Exhibit Number |
Description | |
99.1 | Press Release titled Alexza Receives Complete Response Letter for ADASUVE NDA, dated May 3, 2012. |
Exhibit 99.1
NEWS RELEASEfor immediate release
Alexza Receives Complete Response Letter for ADASUVE NDA
Complete Response Letter Outlines Manufacturing Deficiencies
Conference Call Scheduled for Tomorrow at 8:00 a.m. Eastern Time, May 4, 2012
Mountain View, CaliforniaMay 3, 2012Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg. The CRL was issued by FDAs Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
In the CRL, the FDA noted, During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved. Alexza believes the deficiencies are medical device specific and readily addressable. Alexza plans to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical. Alexza looks forward to working to resolve the remaining issues in a timely manner.
There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL. With respect to the ADASUVE Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the action letter has been submitted. The CRL also contained comments on Alexzas draft product labeling. Alexza believes that there is substantial agreement between Alexza and the FDA on the REMS and product labeling.
Conference Call Information8:00 a.m. Eastern Time on May 4, 2012
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=PG7Q7BCVY.
To access the live conference call via phone, dial 888-679-8040. International callers may access the live call by dialing +1-617-213-4851. The reference number to enter the call is 19038430.
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The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via phone 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 44033163. A replay of the call will be available for two weeks following the event.
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. Alexzas technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)
ADASUVE (Staccato loxapine) is Alexzas lead program, which is being developed for the acute treatment of agitation in adults with schizophrenia or bipolar disorder. Alexza completed and announced positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA in December 2009. In October 2010, the Company received a CRL from the FDA regarding the application. The Company completed an end-of-review meeting with the FDA in December 2010, a REMS guidance meeting with the FDA in April 2011, and the ADASUVE NDA was resubmitted in August 2011. In December 2011, the ADASUVE NDA was the subject of an advisory committee meeting. In January 2012, Alexza received notice of a 90-day extension of the PDUFA goal date, from February 4, 2012 to May 4, 2012. In May 2012, Alexza received a second CRL outlining manufacturing deficiencies.
In October 2011, the Company established a commercial partnership for ADASUVE with Grupo Ferrer Internacional, S.A. Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and is Alexzas partner in the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Alexza filed its ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in October 2011.
For more information about Alexza, the Staccato system technology or the Companys development programs, please visit www.alexza.com.
Safe Harbor Statement
This news release and the planned conference call will contain 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 potential of the Company to adequately address the issues
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in the recently received CRL, the timing of the Companys response to the CRL, the timing and prospects for regulatory approval to market ADASUVE in the U.S., the timing and prospects for regulatory approval to market ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries and the adequacy of the Companys capital to support the Companys operations, the Companys ability to raise additional funds and the potential terms of such potential financings. 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, 2011 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.
CONTACT: |
Thomas B. King President and CEO 650.944.7634 tking@alexza.com |
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