Prothena Announces Bristol Myers Squibb Opt-in for Exclusive Global License for PRX019, the Second Program from Global Neuroscience Research and Development Collaboration
May 28 2024 - 4:05PM
Business Wire
- Prothena to receive $80 million from Bristol Myers Squibb for
exclusive global license to PRX019, a potential treatment of
neurodegenerative diseases with an undisclosed target
- Prothena will initiate a Phase 1 clinical trial for PRX019 in
2024
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
biotechnology company with a robust pipeline of investigational
therapeutics built on protein dysregulation expertise, today
announced that Bristol Myers Squibb obtained the exclusive global
license for PRX019 and will pay Prothena $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.
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.
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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
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