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Biocon Signs Licensing Agreement with Advaxis for ADXS-HPV

January 31, 2014

Biocon, an Asian biotechnology company, and Advaxis, Inc., a company engaged in developing the next generation of cancer immunotherapies, announced 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, the companies noted in a release.

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," said 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 percent of women in general are estimated to harbor cervical HPV infection at a given time, and 82.5 percent 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 percent 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.

According to the companies, 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.

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