Alfasigma has entered into an exclusive licensing agreement with PhaseBio Pharmaceuticals for the commercialization of bentracimab in 49 countries across Europe and other key markets.
PhaseBio is a biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases.
The agreement covers the countries of the European Union and the European Economic Area, as well as the United Kingdom, Russia, Ukraine and other countries of the Commonwealth of Independent States.
Bentracimab is a new human monoclonal antibody fragment which in previous clinical studies has shown an immediate and prolonged reversal of the antiplatelet effects of Brilinta / Brilique (ticagrelor).
Under the terms of the licensing agreement, PhaseBio will receive an upfront payment of $20 million and may receive $35 million upon obtaining certain pre-revenue regulatory approvals and up to $190 million upon achieving certain sales milestones. in addition to certain tiered royalties on net sales.
The American company will be responsible for developing bentracimab and obtaining approval from the European Medicines Agency (EMA) and the Medicines and Health Products Regulatory Agency (MHRA). Subsequently, the marketing authorization will be assigned to Alfasigma.
Alfasigma will be responsible for obtaining regulatory approval in other territories not covered by the EMA or MHRA approvals and for obtaining and maintaining the regulatory approvals necessary to market and sell the product, including price negotiations and post-marketing commitments.
"The needs of people with hospital diseases are one of our main focuses. It is essential to understand the unmet needs of patients and clinicians and, as in the case of bentracimab, to strive to respond better. In addition to being proud to be able to serve a relevant patient population, we are sure to bring an important and valuable medicine into the Alfasigma specialist product portfolio ", said Pier Vincenzo Colli, Chief Executive Officer of Alfasigma."
"The signing of this commercialization agreement with our new partner, Alfasigma, is a truly momentous occasion for PhaseBio," said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals.
Bentracimab is currently in late-stage clinical development in the REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) trial. REVERSE-IT is a Phase 3, multi-center, open-label, prospective single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.
Previously, bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug.
Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics. ■