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): October 30, 2015

 

 

ALEXZA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-51820   77-0567768

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

Alexza Pharmaceuticals, Inc.

2091 Stierlin Court

Mountain View, California

   94043
(Address of principal executive offices)   (Zip Code)

Registrant’s 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 1 — Registrant’s Business and Operations

 

Item 1.02. Termination of a Material Definitive Agreement.

As further described in Item 8.01 below, Alexza Pharmaceuticals, Inc. (“Alexza”) has entered into negotiations with Teva Pharmaceuticals USA, Inc. (“Teva”), a subsidiary of Teva Pharmaceutical Industries Ltd., to terminate that certain License and Supply Agreement between Alexa and Teva dated May 7, 2013 (the “Teva Agreement”), as previously filed with the Securities and Exchange Commission (the “SEC”) with Alexza’s Quarterly Report on Form 10-Q/A on October 23, 2013. Under the terms of the Teva Agreement, Teva is responsible for all U.S. development and commercialization activities for ADASUVE® (loxapine) inhalation powder, including the U.S. post-approval clinical studies and any additional clinical trials for new indications. Teva also has the exclusive rights to commercialize ADASUVE in the U.S. and the co-exclusive rights (with Alexza and its affiliates) to manufacture the product. The definitive terms of this termination are still to be negotiated between the parties. The information provided below under Item 8.01 is incorporated into this Item 1.02 by reference.

Section 8 — Other Events

 

Item 8.01. Other Events.

On October 30, 2015, Alexza announced it plans to reacquire the U.S. rights for ADASUVE® (loxapine) inhalation powder from Teva with an estimated completion date of January 1, 2016. Alexza and Teva also plan to restructure the obligations under the outstanding note from Teva. The press release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.

Forward-Looking Statements

Statements in this Current Report on Form 8-K that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, Alexza’s plans to reacquire the U.S. rights for ADASUVE® (Staccato® loxapine) and Alexza’s plan to restructure its obligations under the outstanding note from Teva. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. For example, there are risks and uncertainties inherent in the process of negotiating the acquisition of the U.S. rights for ADASUVE from Teva and restructuring the obligations under the outstanding note from Teva. Alexza does not have a defined timeline for this process and is not confirming that the process will result in any specific action or transaction. All forward-looking statements are qualified in their entirety by this cautionary statement. Alexza is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this report as a result of new information, future events or otherwise.

Section 9 — Financial Statements and Exhibits

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number

   

Description

99.1    Press Release titled “Alexza Pharmaceuticals Announces Intent to Reacquire U.S. Rights for ADASUVE® (loxapine) inhalation powder” dated October 30, 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.

 

    ALEXZA PHARMACEUTICALS, INC.
Date: October 30, 2015      
    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 Pharmaceuticals Announces Intent to Reacquire U.S. Rights for ADASUVE® (loxapine) inhalation powder” dated October 30, 2015.


Exhibit 99.1

 

LOGO

NEWS RELEASE - for immediate release

Alexza Pharmaceuticals Announces Intent to Reacquire U.S. Rights

for ADASUVE® (loxapine) inhalation powder

Mountain View, California, October 30, 2015 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it plans to reacquire the U.S. rights for ADASUVE® (loxapine) inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., with an estimated target completion date of January 1, 2016. Alexza and Teva also plan to restructure the obligations under the outstanding note from Teva. Alexza and Teva are working on a transition agreement to continue product availability to patients and health care providers after the return of the rights to Alexza.

“ADASUVE is an effective product. There are considerable challenges in launching a hospital product, especially one as complex as ADASUVE. We appreciate the efforts that Teva has made to date and are looking forward to continuing to build the ADASUVE brand,” said Thomas B. King, Alexza President and CEO. “We remain confident in ADASUVE’s long-term commercial prospects and plan to work with Teva to effect a smooth transition. It is our intention to work diligently in 2016 to identify a new U.S. commercial partner for ADASUVE.”

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. Alexza’s products and development pipeline are based on the Staccato® system, a hand-held inhaler designed to deliver a pure drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. Active pipeline product candidates include AZ-002 (Staccato alprazolam) for the management of epilepsy in patients with acute repetitive seizures and AZ-007 (Staccato zaleplon) for the treatment of patients with middle of the night insomnia.

ADASUVE® is Alexza’s first commercial product and is currently available in 20 countries, 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 Alexza’s current commercial partner for ADASUVE in the United States. Grupo Ferrer Internacional SA is Alexza’s commercial partner for ADASUVE in Europe, Latin America, the Commonwealth of Independent States countries, the Middle East and North Africa countries, Korea, Philippines and Thailand.

ADASUVE® and Staccato® are registered trademarks of Alexza Pharmaceuticals, Inc. For more information about Alexza, the Staccato system technology or the Company’s development programs, please visit www.alexza.com.

 

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LOGO

 

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 of Alexza and its partners to effectively and profitably commercialize ADASUVE, Alexza’s ability to secure a new U.S. commercial partner for ADASUVE and the terms of any such partnership, estimated product revenues and royalties associated with the sale 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, 2014 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.

 

CONTACT:    Thomas B. King
   President and CEO
   +1 650 944 7900 (investors / media)
   investor.info@alexza.com

 

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