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
chemotherapeutic agents.”
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 HPV strains.*
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 world.
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 Centre) 2010.
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. www.biocon.com
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
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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. 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.
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