Bangalore, Karnataka, India and New Jersey, United States
Biocon Ltd., (BIOCON.BO), Asia's premier biotechnology company, and Advaxis,
Inc., (NASDAQ: ADXS), a leader in developing the next generation of cancer
immunotherapies, announced today that they have entered into an exclusive
licensing agreement for co-development and commercialization of ADXS-HPV, a
novel cancer immunotherapy for the treatment of human papillomavirus
(HPV)-associated cervical cancer in women, for India and key emerging markets.
As per the agreement, Biocon will also have access to Advaxis' innovative and
proprietary immunotherapy technology that can be leveraged for the development
of other novel therapeutics for various unmet medical needs.
Chairperson and Managing Director of Biocon, Kiran Mazumdar-Shaw said, “Biocon
is committed to finding solutions for women's health issues. This partnership
will enable us to develop ADXS–HPV a novel immunotherapy to combat cervical
cancer in women. It is a promising technology that has the ability to suppress
the tumor inside the micro-environment, and can be leveraged for developing
several other novel therapeutics to address various unmet medical needs of
patients in India and other emerging markets.”
“We are excited to partner with Biocon, one of the world's leading
biotechnology companies and the largest biotechnology company in India to bring
our innovative cancer immunotherapy for cervical cancer to women with few
alternatives,” commented Daniel J. O'Connor, Chief Executive Officer of
Advaxis. “This agreement gives us reach into key markets where the number of
patients with HPV-associated cancers is overwhelming.”
Dr. Abhijit Barve, President of Research & Development at Biocon said, “The
clinical data generated so far with ADXS-HPV look very encouraging in patients
with advanced metastatic disease who were resistant or refractory to existing
therapies. The clinical responses were comparable to prevalent chemotherapy
agents and this was achieved with very low incidence of adverse events. Hence
ADXS-HPV is likely to offer patients a safe and effective alternate to
Cervical cancer is one of the most frequent cancers in women in India. Over 366
million women of the age of over 15 years, are at a risk of developing cervical
cancer. It is estimated that every year over 134,000 women are diagnosed with
cervical cancer in India and nearly 73,000 die from this disease. Approximately
7.9% of women in general are estimated to harbor cervical HPV infection at a
given time, and 82.5% of invasive cervical cancers are attributed to high-risk
According to WHO, in 2008, there were over 530,000 new cases of cervical cancer
worldwide, 90% of these were reported in developing countries. While globally
there were over 300,000 deaths, the African region recorded over 50,000 deaths
and Asian countries reported over 150,000 deaths for the year.
ADXS-HPV has the potential to address this huge challenge in the developing
Under the terms of the agreement, Advaxis will provide exclusive
commercialization rights for ADXS-HPV to Biocon for India, and key emerging
markets for all HPV-associated cancers. Advaxis will manufacture and supply
ADXS-HPV to Biocon.
*Source: WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information
About Biocon Limited
Established in 1978, Biocon Limited, (BSE code: 532523, NSE Id: BIOCON, ISIN Id:
INE376G01013) is India's largest and Asia's leading biotechnology company with a
strategic focus on biopharmaceuticals and research services. It is a fully
integrated, innovation-driven biopharma enterprise offering affordable solutions
for chronic diseases to patient's worldwide. Biocon's robust product portfolio
includes the world's first Pichia-based recombinant human Insulin, INSUGEN(R),
Glargine, BASALOG®, India's first biologic BioMAb-EGFR ® for head and neck
cancer and world's first biosimilar trastuzumab, CANMAb™. It has also
successfully developed its second novel biologic Itolizumab, a 'first in class'
anti-CD6 monoclonal antibody, introduced as ALZUMAb™ for psoriasis in India.
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 to stimulate the immune
system to selectively target cancer cells while reducing tumor defenses.
ADXS-HPV, Advaxis' lead immunotherapy for the treatment of HPV-associated
cancers, has improved survival and objective tumor responses in patients with
recurrent cervical cancer. ADXS-HPV has Orphan Drug Status for both anal and
head and neck cancers. As part of its 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, Advaxis has granted an exclusive license for the development and
commercialization of ADXS-HPV in Asia.
ADXS-cHER2 is an immunotherapy for the treatment of HER2 overexpressing cancers
(such as breast, gastric, and other cancers in humans and for osteosarcoma in
canines). Advaxis' lead animal-health immunotherapy, ADXS-cHER2, has
demonstrated encouraging survival data in a Phase 1 trial in canine
osteosarcoma. These data provide the rationale to advance this same
immunotherapy into a Phase 1 clinical trial in women with HER2-positive breast
cancer. The Company is preparing to submit an IND for ADXS-cHER2 in breast
cancer in 2014.
Advaxis has created over 15 distinct immunotherapies based on its platform
either directly or through strategic collaborations with recognized centers of
excellence such as: the University of Pennsylvania, Brown University, the
Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount
Sinai, and others.
For more information please visit www.advaxis.com or connect with us on
Facebook, Twitter, Google+ and LinkedIn.
Certain statements in this release concerning our future growth prospects are
forward-looking statements, which are subject to a number of risks,
uncertainties and assumptions that could cause actual results to differ
materially from those contemplated in such forward-looking statements. Important
factors that could cause actual results to differ materially from our
expectations include, amongst others general economic and business conditions in
India, our ability to successfully implement our strategy, our research and
development efforts, our growth and expansion plans and technological changes,
changes in the value of the Rupee and other currency changes, changes in the
Indian and international interest rates, change in laws and regulations that
apply to the Indian and global biotechnology and pharmaceuticals industries,
increasing competition in and the conditions of the Indian biotechnology and
pharmaceuticals industries, changes in political conditions in India and changes
in the foreign exchange control regulations in India. Neither our company, our
directors, nor any of our affiliates, have any obligation to update or otherwise
revise any statements reflecting circumstances arising after this date or to
reflect the occurrence of underlying events, even if the underlying assumptions
do not come to fruition.
Media Contact Details
Seema Ahuja , Head-Corporate Communications , Biocon Media Contacts ,
+919972317792 , +91-80-28082222 , email@example.com
Saurabh Paliwal , Head Investor Relations , Biocon: Investors Contact ,
+919538380801 , firstname.lastname@example.org
Rumman Ahmed , Manager-Corporate Communications , Biocon Limited ,
+919845104173 , +91-80-28082223 , email@example.com
Lisa Caperelli , Advaxis, Inc , 215.206.1822 , firstname.lastname@example.org
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