Bentracimab is a novel, monoclonal antibody fragment that reverses the antiplatelet activity of ticagrelor, an antiplatelet medicine marketed by AstraZeneca as Brilinta, prescribed for patients who survived a heart attack or stroke, or with coronary artery disease (CAD)
France-based specialty pharmaceutical company SERB Pharmaceuticals has acquired US-based drug development company, SFJ Pharmaceuticals’ exclusive US rights to bentracimab.
Bentracimab is a novel, monoclonal antibody fragment that works to reverse the antiplatelet activity of ticagrelor, an antiplatelet medicine marketed by AstraZeneca as Brilinta.
Ticagrelor is prescribed for patients who survived a heart attack or stroke, or who have acute coronary syndromes or coronary artery disease (CAD).
If approved by the FDA, bentracimab would allow the patients to benefit from the antithrombotic effect of ticagrelor, prevents vascular events and reduces risk of death.
Also, the drug will provide physicians with a way to control bleeding in rare emergency situations such as surgery or a major bleeding event.
SFJ will be responsible for the ongoing clinical trials of bentracimab and will work together with SERB to file a regulatory application with the US FDA, which is expected later this year.
SERB Pharmaceuticals executive chairman Jeremie Urbain said: “The acquisition of bentracimab marks a significant step in our strategy to grow through investment in innovative, biologic products for critical care conditions and leverages our existing commercial and technical capabilities.
“We’re excited to partner with SFJ, recognized leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.”
SFJ provides at-risk funding and the global clinical development management services, necessary for regulatory submission, to pharmaceutical and biotechnology companies.
According to a prespecified interim analysis of the ongoing Phase 3 REVERSE-IT clinical trial, bentracimab has immediately and sustainably reversed the antiplatelet effects of ticagrelor.
Also, the drug was generally well tolerated, with only minimal adverse events reported.
In 2019, bentracimab has been granted the US FDA Breakthrough Therapy Designation, which advances the development and review of drugs that improves current treatment.
Leopoldo Zambeletti served as advisor to SFJ, while Evercore served as advisor to SERB, on this transaction.
SFJ chief executive officer Robert DeBenedetto said: “We are pleased to partner with Jeremie and the entire SERB team on this important step to help advance bentracimab to patients.
“Bentracimab has recognized potential benefits and we have confidence that SFJ in collaboration with SERB will be able to expeditiously and efficiently see bentracimab through the approvals process by the US FDA.”