Under the terms of the agreement, Teva will assume responsibility for regulatory registration in Israel, provide financial support for local development, and will commercialize the product in the region. Specific financial terms were not disclosed, but the agreement allows for significant royalty payments to Galena Biopharma on future sales.
Kaplan Medical Center department of oncology head Dr. Noa Efrat and an investigator for the trial in Israel said, "We are embarking on a very exciting and innovative venue for the adjuvant treatment of early breast cancer. In this study we are boosting the body's natural immune system to deal with possible residual cancer cells still present. The biological reasoning behind this treatment is sound. We hope that the results of this large randomized study will confirm the encouraging results seen in earlier studies using this agent,"
Galena Biopharma president and CEO Mark Ahn said, "This agreement is the first piece of our global commercialization strategy. Teva is a world-class pharmaceutical company and a major pharmaceutical company in Israel. We look forward to their valuable financial support towards our development goals in Israel, as well as market leadership for NeuVax commercialization in the region."
Israel will be the location of at least four clinical trial sites for the NeuVax Phase III trials.
According to the US National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually.
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