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.
Copyright Business Wire 2013