Galena Biopharma (GALE) Enters NeuVax Commercialization Agreement w/ Teva (TEVA)
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Galena Biopharma, Inc. (Nasdaq: GALE) has signed an agreement with a subsidiary of Teva Pharmaceutical Industries Limited (NYSE: TEVA) for the commercialization of NeuVax™ (nelipepimut-S or E75) in Israel.
"This agreement is the first piece of our global commercialization strategy," said Mark Ahn, Ph.D., President and Chief Executive Officer, Galena Biopharma. "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."
Under the agreement, Teva Israel 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.
Israel will be the location of at least four clinical trial sites for the NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study.
"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," commented Dr. Noa Efrat (Ben-Baruch), M.D., Head Department of Oncology at Kaplan Medical Center, and an investigator for the trial in Israel.
"This agreement is the first piece of our global commercialization strategy," said Mark Ahn, Ph.D., President and Chief Executive Officer, Galena Biopharma. "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."
Under the agreement, Teva Israel 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.
Israel will be the location of at least four clinical trial sites for the NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study.
"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," commented Dr. Noa Efrat (Ben-Baruch), M.D., Head Department of Oncology at Kaplan Medical Center, and an investigator for the trial in Israel.
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