Key Partnerships

Earlier this week we announced that we secured our second key strategic partnership by entering into an agreement for the co-development and commercialization of ADXS-HPV for the treatment of cervical cancer in women in India and other emerging markets.  This is a huge accomplishment for the Advaxis team and our fight against cervical cancer.

Our goal is to have our treatments be widely available to those who need it most and this is where Biocon’s true value as a partner is clear. As the dominant biopharmaceutical company in India, Biocon has a proven track record of successfully interacting with Indian regulatory agencies to gain approval for its own products and on behalf of its partners. They also have a powerful commercial sales force and distribution strengths to establish a high level of post-approval success. Biocon’s validation and scientific support, supplemented by their regulatory experience and sales network, will be valuable as they prepare to seek approval and commercialization of ADXS-HPV to address the dire need that cervical cancer has created in India.

How do we define India as a population that is in dire need? Research, primarily through the World Health Organization (WHO), shows that cervical cancer is the leading cause of cancer deaths in Indian women killing more than 70,000 women every year. Many patients do not respond to existing chemotherapeutic agents which exhibit severe side effects, limiting a patient’s compliance to therapy. Like Biocon, we believe there is a a large unmet need among this population and our immunotherapy could serve as an effective and safe alternative to standard therapy in patients with recurrent or refractory cervical cancer.

Under the terms of this deal, we will supply our immunotherapy, ADXS-HPV, to Biocon and Biocon will be required to purchase ADXS-HPV exclusively from us at a specified contract price. Upon commercialization of ADXS-HPV in India, we will receive a double-digit percentage of the net sales. This has the potential to generate tens of millions of dollars in revenue to Advaxis over the lifetime of the agreement.

Our global commercialization strategy is to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers. In December, we granted an exclusive license to Global Biopharma for the development and commercialization of ADXS-HPV in Asia. Through our partnership with Biocon, we intend to expand our global presence by potentially bringing our immunotherapy to the 70,000 women that are losing their lives to cervical cancer in India every year.

Thank you for taking the time to read this blog, I look forward to continuing to share updates.

Warmest regards,

Dan O’Connor

 

  • DhDHoora

    January 26, 2014 - 8:17 pm

    Thanks Dan.

    Can you add some color as to the process and timelines for regulatory approval of ADXS-HPV in India and Asia? Many of us are familiar with the FDA rat race — but are international regulatory bodies as inflexible and the FDA? Seems that with ADXS-HPV possibly being a drug of last resort, it would receive some kind of fast track status. Might this be the case?

    All the very best and keep up the good work!
    Don

Dan joined Advaxis in January 2013 as Senior Vice President, Chief Legal and Business Development Officer, was promoted to Executive Vice President in May 2013, and was appointed President and Chief Executive Officer of Advaxis in August 2013.

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