PhaseBio Pharmaceuticals (PHAS.Q), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary disease, announced today that it has entered into an exclusive licensing agreement with Alfasigma S.p.A.
“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,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals.
Alfasigma is a privately owned specialty pharmaceutical company dedicated to commercializing medicines in Europe and other key markets. Established in 2015, Alfasigma is one of the top 5 pharmaceutical companies in Italy. Specializing in gastroenterology and vascular disease, the company hopes to become one of the leading specialty companies by 2025, providing better health and quality of life for patients, caregivers and healthcare providers.
According to PhaseBio’s latest announcement, Alfasigma will assist the Company in commercializing its bentracimab. Bentracimab refers to PhaseBio’s novel ticagrelor reversal agent used to treat or prevent major bleeding. Ticagrelor is a medication that is prescribed to prevent a serious or life-threatening heart attack or stroke. However, one of many side effects of ticagrelor is the possibility of serious or life-threatening bleeding. How pleasant. With this in mind, PhaseBio’s bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated potential in mitigating concerns regarding bleeding risks associated with ticagrelor.
Through this agreement, Alfasigma will help PhaseBio bring bentracimab to the European Union and European Economic Area, as well as the United Kingdom, Russia, Ukraine, and other countries within the Commonwealth of Independent States. Under the terms of the license agreement, 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.
“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,” said Pier Vincenzo Colli, Chief Executive Officer of Alfasigma.
Bentracimab is currently in late-stage clinical development in the REVERSE-IT trial. REVERSE-IT refers to PhaseBio’s Phase 3 trial designed to study the reversal of antiplatelet effects of ticagrelor with bentracimab in patients who present major or life-threatening bleeding or who require urgent surgery. The trial is enrolling patients faster that PhaseBio originally projected, and the Company now expects to complete enrollment of the first 100 patients in mid-2021, with a Biologics License Application (BLA) submission planned for mid-2022. For context, a BLA is a request for permission to introduce a biologic product into interstate commerce. 
PhaseBio’s share price opened at $4.10, up from a previous close of $3.95. The Company’s shares are down -0.25% and are currently trading at $3.94 as of 10:34AM ET. This indicates that there has been some change following the news.