Prothena Announces Bristol Myers Squibb Opt-in for Exclusive Global License for PRX019, the Second Program from Global Neuroscience Research and Development Collaboration
Prothena (NASDAQ: PRTA) announced that Bristol Myers Squibb has acquired an exclusive global license for PRX019, a potential treatment for neurodegenerative diseases, resulting in an $80 million payment to Prothena. The FDA cleared PRX019's investigational new drug application in December 2023, and Prothena plans to start a Phase 1 clinical trial by late 2024. The collaboration with Bristol Myers Squibb aims to advance PRX019 as part of Prothena's broader portfolio, with potential additional milestone payments totaling up to $617.5 million and tiered royalties on net sales.
- Prothena receives $80 million from Bristol Myers Squibb for PRX019's exclusive global license.
- FDA cleared the IND application for PRX019 in December 2023.
- Prothena plans to begin a Phase 1 clinical trial for PRX019 by the end of 2024.
- Potential additional milestone payments could total up to $617.5 million.
- Prothena will receive tiered royalties on net sales of PRX019.
- The target for PRX019 remains undisclosed, which may cause uncertainty.
- The Phase 1 clinical trial will not start until late 2024, leading to potential delays in development.
- Success of PRX019 is contingent on future clinical trial outcomes and regulatory approvals.
Insights
The acquisition of the exclusive global license for PRX019 by Bristol Myers Squibb for
However, investors should be aware that these milestone payments are contingent on successful development and commercialization, which carry inherent risks. Additionally, Prothena's ability to manage the clinical trial process efficiently and achieve FDA approval for PRX019 will be important in realizing these potential revenues.
PRX019 is positioned as a potential treatment for neurodegenerative diseases, an area with significant unmet medical needs. The global burden of diseases such as Alzheimer's and Parkinson's is substantial and any advancement in this field can be transformative for patients. The FDA's clearance of the investigational new drug application (IND) is a positive indicator of the drug's potential, though it’s still in early-stage development.
The planned initiation of Phase 1 clinical trials in 2024 will be the next critical step. Phase 1 trials primarily focus on assessing safety and dosing, so it will be important to monitor the results closely. Positive outcomes in this phase can build strong momentum for subsequent trials and partnerships.
The collaboration between Prothena and Bristol Myers Squibb illustrates a strategic alignment in the biopharmaceutical sector, particularly in the lucrative and high-stakes field of neuroscience. Given the competitive landscape, the partnership can provide Prothena with the necessary resources and expertise to bring PRX019 to market more efficiently. For Bristol Myers Squibb, this deal expands their neuroscience pipeline, enhancing their position in the market.
Investors should also consider the potential market size for neurodegenerative disease treatments, which is growing due to an aging population. Successful development of PRX019 could result in significant market penetration, especially if the drug proves to be a disease-modifying treatment, which is currently an area of high demand and limited options.
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Prothena to receive
$80 million - Prothena will initiate a Phase 1 clinical trial for PRX019 in 2024
The
“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
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential of PRX019; the timing for advancement of our PRX019 program, including initiation of a Phase 1 study by year-end 2024; and amounts we might receive under our collaboration with BMS. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2024, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240528521971/en/
Media
Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com
Investors
Mark Johnson, CFA, Vice President, Investor Relations
650-417-1974, mark.johnson@prothena.com
Source: Prothena Corporation plc
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