Bristol Myers Squibb has obtained the exclusive global license for Prothena’s PRX019 and will pay Prothena, a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, $80 million.
The U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, in December 2023. Prothena plans to initiate the Phase 1 clinical trial for PRX019 by year-end 2024.
“Our collaboration agreement with Bristol Myers Squibb has now generated two clinical development programs, supporting both organizations’ commitments to advancing potential therapeutics to help treat neurodegenerative diseases. We are proud of this partnership and are excited that Bristol Myers Squibb has exercised their option for the exclusive global license for PRX019. With the IND in effect and our agreement with Bristol Myers Squibb in place, we’re well-positioned to initiate the Phase 1 clinical trial by year-end 2024,” said Gene Kinney, PhD, President and Chief Executive Officer at Prothena.
“At Prothena, we are continuing to leverage strategic partnerships to further advance our broad portfolio of product candidates to treat diseases caused by protein dysregulation. We believe that our portfolio has the potential to help the millions of patients suffering from these devastating diseases.”
“Our expanding research and development efforts in neuroscience demonstrate our commitment to tackling some of the most pressing areas of unmet medical need. Through our partnership with Prothena, we have identified and advanced PRX019 as a potential disease-modifying treatment option for patients suffering from neurodegenerative diseases,” said Richard Hargreaves, Senior Vice President and Head of Bristol Myers Squibb’s Neuroscience Thematic Research Center.
“PRX019 adds to our growing neuroscience pipeline, and we look forward to continuing its development as we strive to make a meaningful improvement on patients’ lives.”
As part of the PRX019 global license with Bristol Myers Squibb, Prothena will be eligible to receive additional development, regulatory, and sales milestone payments of up to $617.5 million. Prothena also will be eligible to receive tiered royalties on net sales.