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): December 9, 2013

  

ADVAXIS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   00028489   02-0563870
(State or other jurisdiction of
incorporation)
  (Commission File
Number)
  (IRS Employer Identification
No.)

 

305 College Road East
Princeton, New Jersey
  08540
(Address of principal executive offices)   (Zip Code)

 

Registrant's telephone number, including area code: (609) 452-9813

 

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):

 

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On December 9, 2013, Advaxis, Inc. (the “Company”) and Global BioPharma, Inc., a corporation organized under the laws of the Republic of China, (“GBP”) entered into an Exclusive License and Technology Transfer Agreement (the “Agreement”).

 

Pursuant to the Agreement, the Company granted GBP an exclusive license (with a right to sublicense) to certain technology, know-how, trade secrets, proprietary information and patents relating to (i) the prevention and treatment of Human Papillomavirus (“HPV”) associated diseases; (ii) pharmaceutical products containing ADXS-HPV, an immunotherapy that is designed to target cells that have been transformed into dysplastic and malignant tissues by HPV, as the active ingredient; and (iii) ADXS-HPV. Under the license grant, GBP has the right to develop, manufacture, have manufactured, import, use and commercialize certain pharmaceutical products indicated for HPV-associated diseases in the following territories: (i) all countries and territories in the continent of Africa except for Algeria, Egypt, Eritrea, Kenya, Libya, Morocco, Sudan, Tunisia, and Western Sahara; (ii) all countries and territories in the continent of Asia except for Armenia, Bahrain, Bangladesh, Bhutan, Burma, India, Iran, Iraq, Jordan, Kuwait, Lebanon, Malaysia, Maldives, Nepal, Oman, Pakistan, Qatar, Saudi Arabia, Sri Lanka, Syria, United Arab Emirates and Yemen; and (iii) Azerbaijan, Belarus, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan (collectively, the “Territory”).

 

In connection with the execution of the Agreement, the Company shall receive an annual license fee. This annual license fee expires on the year that GBP commences royalty payments. The Company shall also receive (i) event-based milestone payments and (ii) royalties in the single to double digits based on certain net sales of pharmaceutical product(s) that (a) includes ADXS-HPV as the active ingredient or (b) uses or embodies the licensed technology, in each case, for use in connection with all present and future indications related to HPV-associated diseases (“Product(s)”) in the Territory. According to the Agreement, the annual license fees referenced above will be creditable against any future royalty payments until all such annual license fees previously paid by GBP have been fully credited against the royalty payments. In addition, GBP will make an investment in Advaxis by purchasing from the Company a specified number of shares of its common stock at market price. GBP will also have an option to purchase certain additional shares of Advaxis stock from the Company at a 150% premium to the stock price on the effective date of the Agreement.

 

Additionally, GBP, at its cost, shall provide up to one third of the patients, but not more than 150 patients, needed for the Company’s U.S. registrational study relating to invasive cervical cancer.

 

Pursuant to the terms of the Agreement, GBP will be responsible for developing the Product in the Territory at its own costs. In consideration of the development expenses to be incurred by GBP in the Territory, the Company will pay GBP a cross royalty at a rate of significantly less than one percent relating to the Company’s U.S. sales of Products during the royalty term.

 

GBP will seek and maintain regulatory approval of Products in the Territory. As per the terms of the Agreement, the Company will initially conduct the manufacturing, packaging, labeling, release testing, and stability testing for laboratory and clinical supplies required for obtaining regulatory approval in the Territory for each such Product. GBP will pay for all of the Company’s costs associated with clinical and commercial supplies of the Product, provided that these costs do not exceed a budget agreed to by the Company and GBP.

 

Pursuant to the Agreement, GBP is obligated to, at its cost, develop manufacturing capabilities so that it may act as a primary or secondary source of finished product manufacturing for the Company outside of the Territory. The Company will transition the manufacturing, packaging, labeling, release testing, and stability testing for laboratory and clinical supplies required for obtaining regulatory approval in the Territory to GBP as soon as reasonably practicable.

 

 
 

 

The Agreement expires on the date of expiration of all royalty and other payment obligations under the Agreement, unless earlier terminated upon the mutual written agreement of the Parties or in accordance with various termination provisions set forth therein. The term associated with royalty payments expires upon the later of twenty (20) years from the Agreement’s effective date or the expiration of the last valid patent claim covering a Product.

 

Item 7.01 Regulation FD Disclosure.

 

On December 9, 2013, the Company issued a press release announcing the Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The information contained in Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Exhibit No.   Description
99.1   Press Release dated December 9, 2013.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ADVAXIS, INC.
     
  By:   /s/ Daniel J. O’Connor
      Name: Daniel J. O’Connor
      Title: Chief Executive Officer

Date: December 13, 2013

 

 

 

 

 

 

 

 

 

 

 

 

 

Advaxis signs exclusive licensing agreement for development and commercialization of adxs-hpv in asia

 

License funded by one of the largest Taiwanese pharmaceutical companies

 

Princeton, NJ – December 9, 2013 – Advaxis, Inc., (NASDAQ: ADXS), a leader in developing the next generation of cancer immunotherapies, announced that it has entered into an exclusive licensing agreement for the development and commercialization of ADXS-HPV with Global BioPharma, Inc. (GBP), a Taiwanese based biotech company funded by a group of investors led by Taiwan Biotech Co., Ltd (TBC). TBC is one of the top five pharmaceutical companies in Taiwan and formed GBP solely to focus on the development and commercialization of ADXS-HPV for the treatment of human papillomavirus (HPV)-associated diseases. The GBP territory covers over 4 billion people with over 200,000 annual diagnoses of cervical cancer, accounting for roughly 40% of the world’s cases, according to WHO statistics.

 

GBP plans to conduct registration trials with ADXS-HPV for the treatment of advanced cervical cancer and will explore the use of Advaxis’ lead product candidate in several other indications including lung, head and neck, and anal cancer.

 

GBP will pay Advaxis event-based financial milestones, an annual development fee, and annual net sales royalty payments in the high single to double digits. In addition, as an upfront payment, GBP will make an investment in Advaxis by purchasing from the Company shares of its common stock at market price. GBP will also have an option to purchase additional shares of Advaxis stock from the Company at a 150% premium to the stock price on the effective date of the agreement.

 

GBP will be responsible for all clinical development and commercialization costs in the GBP territory. In collaboration with Advaxis, GBP will also identify and pay the clinical trial costs for up to 150 patients with cervical cancer for enrollment in Advaxis’ U.S. and GBP’s Asia registrational programs for cervical cancer. GBP is committed to establishing manufacturing capabilities for its own territory and to serving as a secondary manufacturing source for Advaxis in the future. Under the terms of the agreement, Advaxis will exclusively license the rights to ADXS-HPV to GBP for the Asia, Africa, and former USSR territory, exclusive of India and certain other countries, for all HPV-associated indications. Advaxis will retain exclusive rights to ADXS-HPV for the rest of the world.

 

“The ADXS-HPV technology platform is groundbreaking,” commented George Ko, Chairman of Taiwan Biotech Co. and Global BioPharma. “We are looking forward to working with Advaxis which we believe is a company at the forefront of cancer immunotherapy research with the ability to treat patients with few options in countries where treatments are needed most.”

 

 
 

 

“This agreement is the first to be executed as part of Advaxis’ global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers,” commented Daniel J. O’Connor, President and CEO of Advaxis. “Funded by one of the largest Taiwanese pharmaceutical companies, this deal further validates Advaxis’ proprietary immunotherapy technology. It is impressive that a new company has been exclusively formed and funded by a team of seasoned biopharmaceutical professionals to develop and commercialize ADXS-HPV in Asia and other important markets. The GBP management team has extensive experience in research, clinical trials, CMC, manufacturing, and business development, and has set an aggressive strategy to conduct clinical trials and pursue commercialization for ADXS-HPV in its territory.”

 

About Taiwan Biotech Co., Ltd. and Global BioPharma, Inc.

 

Taiwan Biotech Co., Ltd. (TBC) is one of the top five pharmaceutical companies in Taiwan with annual domestic sales in excess of $100M in the healthcare sector. TBC engages in the research, development, manufacture, representation, and distribution of pharmaceutical drugs, medical devices, and active pharmaceutical ingredients. The company offers health care products, pharmaceutical drugs, antimicrobial agents, anti-diabetic agents, amino acids agents, external agents, syrups, ophthalmic agents, antibiotics, neuromuscular disorder drugs, and injections, as well as vitamin preparations. TBC currently has relationships with Teva (as a result of its acquisition of Cephalon), Taisho Pharmaceutical, Towa Pharmaceutical, PolyPeptide Laboratories, Sunward Pharmaceutical, and Besins Healthcare Ltd.

 

Global BioPharma, Inc. (GBP) is formed with a group of seasoned managers with extensive experiences in research, clinical trials, CMC, manufacturing, and business development with the financial supports of VCs and individuals led by TBC. GBP is dedicated to the development, manufacturing, and commercialization of ADXS-HPV for the treatment of HPV-associated diseases.

 

About Advaxis, Inc.

 

Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein(s) that is designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

 

ADXS-HPV is currently being evaluated in Phase 1 and 2 clinical trials for HPV-associated cancers: recurrent cervical cancer (completed Phase 2 study conducted in India), locally advanced cervical cancer (GOG/NCI U.S. study, Clinical Trials.gov Identifier NCT01266460), head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792, Mt. Sinai study, Clinical Trials.gov Identifier NCT02002182), and anal cancer (BrUOG U.S. study, Clinical Trials.gov Identifier NCT01671488). Advaxis has over 15 distinct immunotherapies in various stages of development, developed directly by Advaxis and through strategic collaborations with recognized centers of excellence such as: the University of Pennsylvania, the Georgia Regents University Cancer Center, Icahn School of Medicine at Mount Sinai, and others.

 

 

 
 

 

For more information please visit: www.advaxis.com

 

Forward-Looking Statements

 

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’ proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers; the terms and conditions of the license agreement with GBP, whether an event-based financial milestones under the agreement will be achieved and associated payments made, whether annual development fees will be paid, whether any product will be successfully developed and commercialized, whether any annual net sales royalty payments will be made, whether GBP will exercise its option to purchase additional shares of Advaxis common stock; whether GBP will successfully undertake all clinical development and commercialization in the GBP territory, whether GBP will identify and pay the clinical trial costs for up to 150 cervical cancer patients for enrollment in Advaxis’ U.S. registrational program for cervical cancer establish manufacturing capabilities to serve as a possible secondary manufacturing source for Advaxis in the future. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

 

Contact Information:

 

Lisa Caperelli

Senior Director of Investor Relations and Corporate Communications

Advaxis, Inc.

caperelli@advaxis.com

215.206.1822

 

SOURCE: Advaxis, Inc.

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