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): June 18, 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))

 

 

 

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Section 1 – Registrant’s Business and Operations

 

Item 1.01.

Entry into a Material Definitive Agreement.

Teva Amendment

On June 17, 2015, Alexza Pharmaceuticals, Inc. (the “Company”) and Teva Pharmaceuticals USA, Inc. (“Teva”) entered into (a) Amendment No. 1 (the “Teva Amendment”) to License and Supply Agreement dated May 7, 2013 (the “Teva Agreement”); and (b) an Amended and Restated Convertible Promissory Note (the “Amended Note”) that amends and restates the Convertible Promissory Note dated May 7, 2013. The Teva Amendment provides for the suspension of certain of Teva’s commercialization diligence obligations set forth in the Teva Agreement during a period in which the Company’s manufacturing obligations for the ADASUVE product in the United States are also suspended.

The Teva Amendment provides for, among other matters: (i) suspension of the Company’s obligation to manufacture ADASUVE product for Teva prior to July 1, 2017 (the “Suspension Period”), with reinstatement if Teva submits a purchase order after July 1, 2017 and before December 31, 2017; (ii) a right for Teva to manufacture ADASUVE product itself; (iii) provides for the other party to reasonably consent to an assignment of the Teva Agreement to a third party; (iii) suspends certain commercialization obligations of Teva during the Suspension Period; (iv) provides the Company the right to increase the loan amount under the Amended Note for reimbursement of the Company’s manufacturing facility rent through the Suspension Period, up to a maximum of $1,675,000; (v) provides for consent by Teva, under certain conditions, to the sale of all of the Company’s ADASUVE manufacturing facility assets and any assignment of manufacturing rights and obligations by the Company to a third party; and (vi) if the Company has assigned, sublicensed, subcontracted, delegated or otherwise transferred its manufacturing rights to a third party, further provides for a right of first offer to Teva with respect to the sale of the Company’s ADASUVE manufacturing facility assets.

The Amended Note provides for (i) increase in the principal amounts available to the Company under the Amended Note for reimbursed manufacturing facility rent through the Suspension Period, up to a maximum of $1,675,000; (ii) extension of the maturity date of principal amounts outstanding under the Amended Note from May 7, 2018 plus the number of days in Suspension Period; (iii) suspends interest on outstanding principal amounts during the Suspension Period; and (iv) allows for prepayment by the Company of all outstanding facility rental reimbursement amounts borrowed by the Company.

Ferrer Amendment

On June 17, 2015, the Company and Grupo Ferrer Internacional, S.A. (“Ferrer”) entered into a Fourth Amendment to Collaboration, License and Supply Agreement (the “Ferrer Amendment”), which amends that certain Collaboration, License and Supply Agreement (the “Ferrer Agreement”) dated October 5, 2011, as amended, to provide for an adjustment to the Company’s manufacturing obligations; a grant of an option for Ferrer to manufacture Staccato Products (defined as those that deliver an active pharmaceutical ingredient by a hand-held, fixed-dosage device relying on the Company’s proprietary technology) for the Company in the Ferrer territory; an expansion of Ferrer’s territory to include additional Middle Eastern, Asian and Latin American countries; amends certain milestones related to first commercial sale in certain markets; and transfers certain specified clinical trials and the Company’s Marketing Authorization Application in the European Union and related regulatory responsibilities and expenses for Staccato loxapine (ADASUVE) to Ferrer.

Specifically, from the period July 1, 2015 through the first purchase order of Staccato loxapine (ADASUVE) from Ferrer on or after December 31, 2016, the Company is relieved of its obligation to manufacture such product for Ferrer and the Company is relieved of its obligation to maintain its current manufacturing facility in compliance with cGMP or other applicable laws during this period. The Company retains the right to assign its manufacturing obligations to a third party, subject to the prior written consent of Ferrer, not to be unreasonably withheld.

In addition, through December 31, 2015 Ferrer has an option to make the decision to manufacture Staccato loxapine (ADASUVE) in its territory as well as for use by Alexza in territories other than the U.S., Canada, China, Hong Kong, Taiwan and Macao. During the term of the Ferrer Agreement, Ferrer has the right to develop and commercialize certain Staccato Products in addition to Staccato loxapine (ADASUVE) on a project-specific basis in the Ferrer territory, in consideration of a royalty in low double digits on net sales to the Company if the Company and Ferrer agree upon such project.

Pursuant to the Ferrer Amendment, Ferrer additionally agreed to become the sponsor and be responsible for the costs associated with the Staccato loxapine (ADASUVE) post-authorization safety study, drug utilization study and the Phase 3 clinical trial for adolescents. The potential milestones payable to the Company upon first commercial sale in each of Russia, Turkey or Brazil shall no longer be payable pursuant to the Ferrer Agreement. Effective upon the Ferrer Amendment, the Ferrer territory includes the following

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countries: European Union, Croatia, Serbia, Bosnia and Herzegovina, Montenegro, Macedonia, Albania, Andorra, Liechtenstein, San Marino, Vaticano, Switzerland, Norway, Iceland, Argentina, Armenia, Azerbaijan, Belarus, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Georgia, Guatemala, Honduras, Kazakhstan, Kyrgyzstan, Mexico, Moldova, Nicaragua, Panama, Paraguay, Peru, Russia, Tajikistan, Turkey, Turkmenistan, Venezuela, Ukraine, Uruguay, Uzbekistan, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Yemen, United Arab Emirates, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, Republic of Korea, Philippines and Thailand.

The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Teva Amendment and the Ferrer Amendment. The omitted material will be included in the request for confidential treatment.

On June 18, 2015, the Company issued a press release describing the Teva Amendment, the Amended Note and the Ferrer Amendment. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Section 9 - Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit Number		Description
99.1		Press Release entitled “Alexza Amends ADASUVE® Commercial Partnership Agreements” dated June 18, 2015.

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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: June 18, 2015
				By:		/s/ Thomas B. King
						Thomas B. King
						President and Chief Executive Officer

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INDEX TO EXHIBITS

 

Exhibit Number		Description
99.1		Press Release entitled “Alexza Amends ADASUVE® Commercial Partnership Agreements” dated June 18, 2015.

Exhibit 99.1

 

NEWS RELEASE - for immediate release

Alexza Amends ADASUVE^® Commercial Partnership Agreements

Ferrer to Assume Additional Financial, Clinical, Regulatory and Commercial Responsibilities

Teva Note Maturity Extended with no Interest Accrual for Specified Period of Time

Mountain View, California - June 18, 2015 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that it has updated and amended its ADASUVE^® (Staccato^® loxapine) commercial partnerships with Grupo Ferrer Internacional, S.A. (Ferrer) and Teva Pharmaceutical Industries Ltd. (Teva). Ferrer is Alexza’s commercial partner for ADASUVE in the European Union, Latin America, the Commonwealth of Independent States and other countries in Europe. Teva is Alexza’s commercial partner for ADASUVE in the United States.

As previously announced in May 2015, Alexza analyzed various initiatives that could reduce manufacturing costs, including supply chain requirements, to make global production more efficient and cost-effective. As a result of this analysis, Alexza plans to complete ADASUVE commercial production for Ferrer and Teva pending orders in the third quarter of 2015, and then will suspend ADASUVE commercial production operations. The primary goal of this action is to reduce Alexza’s underutilized manufacturing capacity, overhead expenses and related costs, while fulfilling the supply requirements of its commercial partners.

In connection with the modification to the manufacturing obligations by Alexza, which also included evaluation of internal and possible external (third party) manufacturing capabilities or alternatives, the companies have updated and amended their commercial partnerships.

“The comprehensive amendments we have completed allow for continued commercialization of ADASUVE while providing flexibility to reflect market learnings during the launch of the product,” said Thomas B. King, President and CEO of Alexza Pharmaceuticals. “We believe the sales during the global launch of ADASUVE do not reflect the clinical benefits ADASUVE can convey to patients, and we remain confident in ADASUVE’s long-term commercial prospects. Early feedback from physicians and patients corroborate the positive clinical profile we observed with ADASUVE during its clinical development.”

King continued, “We believe we are making solid decisions regarding how to run our business for the future and are making strategic changes to our business model. Amending our agreements with Ferrer and Teva will allow us to reduce the costs of producing ADASUVE and eliminate the costs associated with some of the EU post-approval commitments, with the overall goal of substantially reducing our cash burn rate.”

 

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Ferrer and Alexza Agreement Amendment

 

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Alexza’s Manufacturing Obligations: Alexza and Ferrer have agreed to identify more suitable long-term solutions for future ADASUVE manufacturing. Alexza’s current ADASUVE manufacturing obligations are to be suspended for a period of time. During the manufacturing suspension period, Alexza and Ferrer will evaluate internal and possible external (third party) manufacturing capabilities.

 

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Ferrer’s Right to Manufacture: Ferrer and Alexza have agreed that Ferrer will have the option to manufacture ADASUVE at its facilities. If Ferrer chooses to exercise its option, it will be granted ADASUVE manufacturing rights for the Ferrer territories, including an option to manufacture certain additional Staccato products for the Ferrer territories.

 

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MAA Transfer to Ferrer: Alexza will transfer the EU Marketing authorization for ADASUVE (MAA), to Ferrer. The MAA transfer includes the responsibilities for the ongoing post-approval clinical studies (the PASS and DUS studies), a future Phase 3 study in adolescents, as well as ongoing pharmacovigilance responsibilities.

 

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Milestone Payment Elimination: In consideration for taking on additional responsibilities, the specific milestone payments for first commercial sales in Russia, Brazil and Turkey have been eliminated.

 

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Territory and Technology Expansion: Ferrer will gain ADASUVE registration and commercialization rights for Middle East and North Africa (MENA), Korea, Philippines, and Thailand territories. In addition, Ferrer will have the option to develop and commercialize additional Staccato products for the Ferrer territories, with certain rights outside of the current Ferrer territory, in consideration for royalties to Alexza.

Teva and Alexza Agreement Amendment

 

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Alexza’s Manufacturing Obligations: Alexza and Teva have agreed to identify more suitable long-term solutions for future ADASUVE manufacturing. Alexza’s current ADASUVE manufacturing obligations are to be suspended for a period of time. During the manufacturing suspension period, Alexza and Teva will evaluate internal and possible external (third party) manufacturing capabilities.

 

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Modification of Teva’s Commercial Obligations: Alexza and Teva have agreed to adjust certain of Teva’s commercial diligence obligations related to ADASUVE for a period of time. Teva will continue to use commercially reasonable efforts to commercialize ADASUVE in the U.S., be responsible for all related regulatory and clinical activities, and will continue to be responsible for royalties and milestone payments on the U.S. sales of ADASUVE.

 

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Modification to Teva note: The maturity note will be extended for a time equal to the duration of manufacturing suspension period. No interest will accrue on the Teva note during the manufacturing suspension period.

 

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During the manufacturing suspension period Alexza plans to work with its commercial partners to find the most efficient path for future ADASUVE manufacturing and assure ADASUVE supplies for current and new markets.

About ADASUVE (Staccato loxapine)

ADASUVE is the first and only inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The EU marketing authorization for ADASUVE requires that patients receive regular treatment immediately after administration of the product to control acute agitation symptoms. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side effects, such as bronchospasm.

Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder¹. Agitation is a common symptom for these patients², characterized by feelings of distress, anxiety and loss of control.

ADASUVE combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic medicinal product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in intravenous-like pharmacokinetics and rapid systemic effects.

The authorization for ADASUVE in the EU differs from that in the United States, with respect to the indication statement, dose regimen, available dose strengths, and risk mitigation and management plans. For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU, please visit the EMA website. For the full prescribing information including boxed warnings for the U.S., please visit www.adasuve.com.

ADASUVE is currently available in the United States, sixteen EU member countries, one Latin American country, and is also approved in eight countries in Latin America.

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 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.

ADASUVE^®, Alexza’s first commercial product, is based on the Staccato system 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 Alexza’s 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, MENA, Korea, Philippines, and Thailand territories.

 

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ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals, Inc. For more information, please visit www.alexza.com.

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, Teva and Ferrer, to effectively and profitably commercialize ADASUVE, 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.

 

References:

 

1.	Wittchen H.U., et al., 2011. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21, 655-679.

2.	Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation).

 

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