Pier Vincenzo Colli, CEO of Alfasigma
Alfasigma has entered into an exclusive license agreement with PhaseBio Pharmaceuticals, Inc. for the marketing of bentracimab in 49 countries between 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 European Union and 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-market 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 with 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 illnesses 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 in the best possible way. relevant patient population, we are sure to bring an important and precious medicine to the Alfasigma specialist product portfolio “ he has declared Pier Vincenzo Colli, CEO of Alfasigma. “This agreement marks another important step in our journey to consolidate Alfasigma among the main specialty companies internationally, following the recent acquisition of Lumeblue.®. We are proud to have become a point of reference for several companies looking to leverage our experience in key markets in Europe and Asia“.
“The signing of this marketing agreement with our new partner, Alfasigma, is a really important opportunity for PhaseBio”, he has declared Jonathan P. Mow, CEO of PhaseBio Pharmaceuticals. Alfasigma brings deep regional experience to the hospital environment that will help unlock the value of the global bentracimab brand, while allowing PhaseBio to invest in the commercial infrastructure needed to successfully launch the product in the United States. By bringing bentracimab to key markets where a significant percentage of the global ticagrelor patient population resides, Alfasigma will play a critical role in our mission to change the way patients on antiplatelet therapy are managed. We are thrilled to have found a partner who shares our enthusiasm for the potential of bentracimab to address unmet critical needs and look forward to a long and mutually beneficial relationship. “
Concludes Colli: “Having a long experience in the therapeutic area and a consistent hospital presence, I think Alfasigma is really well positioned to make bentracimab available to clinicians and patients. The excellent harmony with PhaseBio will allow us to make bentracimab a global brand in Europe and other key markets “
Bentracimab is currently in an advanced stage of clinical development in the REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) study. REVERSE-IT is a Phase 3, multicentre, open-label, prospective single-arm study designed to investigate the reversal of the antiplatelet effects of ticagrelor with bentracimab in patients with uncontrolled or life-threatening major bleeding or requiring surgery urgent or invasive procedures. Previously, bentracimab was studied in phase 1 and phase 2 clinical trials and has shown the potential to provide lifesaving therapeutic benefits through immediate and prolonged reversal of ticagrelor antiplatelet activity, potentially alleviating concerns about bleeding risks. associated with the use of this antiplatelet drug. Additionally, in a translational study, bentracimab achieved an equivalent reversal of brand-name ticagrelor and multiple generics of ticagrelor.
About Bentracimab (PB2452)
Bentracimab is a new antigen-binding fragment of a recombinant human monoclonal antibody designed to reverse the antiplatelet activity of ticagrelor in situations of major bleeding and urgent surgery. In a Phase 1 clinical trial, bentracimab demonstrated the potential to provide life-saving therapeutic benefits through immediate and prolonged reversal of ticagrelor antiplatelet activity, alleviating concerns about the bleeding risks associated with the use of this antiplatelet drug. The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019. In April 2019, bentracimab received the breakthrough therapy designation from the Food and Drug Administration (FDA). Breakthrough Therapy designation may be granted by the FDA when preliminary clinical evidence indicates that the drug can demonstrate substantial improvement over existing therapy. In September 2019, PhaseBio completed a Phase 2a study in which bentracimab was studied in elderly and elderly subjects on dual antiplatelet therapy with ticagrelor and low-dose aspirin. In addition, the Phase 2a study investigated a bentracimab regimen for reversal of supratherapeutic doses of ticagrelor in younger healthy subjects. In both arms of the study, bentracimab achieved immediate and prolonged reversal of the antiplatelet effects of ticagrelor and was generally well tolerated, with only minor adverse events reported. These results are consistent with the results seen in younger healthy subjects treated with ticagrelor in the previously published Phase 1 study. PhaseBio initiated the REVERSE-IT study, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a biologic licensing application for bentracimab in both major bleeding indications and urgent surgery. There are currently no approved reversal agents for ticagrelor or other antiplatelet drugs.