- The stock price of PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) increased by over 10% pre-market. This is why it happened.
The stock price of PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) – a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases – increased by over 10% pre-market. Investors are responding positively to the company announcing that it has entered into an exclusive licensing agreement with Alfasigma S.p.A., a privately owned specialty pharmaceutical company focused on commercializing medicines in Europe and other key markets for the commercialization of bentracimab.
This agreement covers countries in the European Union and European Economic Area as well as the United Kingdom, Russia, Ukraine and other countries within the Commonwealth of Independent States. Bentracimab is known as a novel and human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta/Brilique (ticagrelor).
Under the terms of the license deal, PhaseBio will receive a $20 million upfront payment and will be eligible to receive up to $35 million in pre-revenue regulatory milestones and up to $190 million in payments contingent upon the achievement of certain sales milestones. PhaseBio is also going to receive tiered royalties on net sales with percentages starting in the low double digits and escalating up to the mid-twenties.
PhaseBio is going to be responsible for developing bentracimab and securing approval with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) after which marketing authorization will be assigned to Alfasigma. Alfasigma is going to be responsible for securing regulatory approval in other territories not covered by EMA or MHRA approvals and for obtaining and maintaining regulatory approvals necessary to market and sell the product, including pricing approvals and post-marketing commitments.
Bentracimab is currently in late-stage clinical development in the REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) trial. And 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 an invasive procedure. The company expects to complete enrollment of the first 100 patients in the REVERSE-IT trial in mid-2021 and is targeting to submit its Biologics License Application (BLA) for bentracimab in mid-2022 although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. So far, nearly all of the patients enrolled have required urgent surgery or an invasive procedure.
Previously, bentracimab was 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. And additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics.
“The signing of this commercialization agreement with our new partner, Alfasigma, is a truly momentous occasion for PhaseBio. Alfasigma brings deep regional expertise in the hospital environment that we believe will help unlock the value of the global bentracimab brand while enabling PhaseBio to invest in the commercial infrastructure necessary to successfully launch the product in the United States. By establishing bentracimab in key markets where a significant proportion 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 excited to have found a collaborator who shares our enthusiasm for the potential of bentracimab to address critical unmet needs and look forward to a long and mutually-beneficial relationship.”
— Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals
“This agreement marks another important milestone in our journey to establish Alfasigma as a major international specialty company, and a partner of choice for companies seeking to leverage our expertise in key markets across Europe. The unmet need for bentracimab is clear: we are proud to serve these patients and bring this valuable medicine into the Alfasigma family of specialty products. As one of the leading European-based specialty pharmaceutical companies with a hospital presence and a core focus in the vascular therapeutic area and other cardio-metabolic diseases, Alfasigma is well positioned to commercialize bentracimab. We share a high degree of enthusiasm with PhaseBio as we look forward to building the global bentracimab brand across Europe and other key markets.”
— Pier Vincenzo Colli, Chief Executive Officer of Alfasigma
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.