Alfasigma acquires the European license for bentracimab from PhaseBio

Alfasigma has entered into an exclusive licensing agreement with PhaseBio Pharmaceuticals, Inc., 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." 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 seeking to leverage our experience in key markets in Europe and Asia."

"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. "Alfasigma brings deep regional expertise in the hospital environment that will help unlock to 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."

Colli concludes: "Having a long experience in the therapeutic area and a consistent hospital presence, I think Alfasigma is really well positioned to bring bentracimab to clinicians and patients. The excellent harmony with PhaseBio will allow us to make bentracimab a global brand in Europe and in other key markets "

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.

About Bentracimab (PB2452)

Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, bentracimab demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor's antiplatelet activity, mitigating concerns regarding 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 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 may demonstrate substantial improvement over existing therapy. In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In both arms of the trial, bentracimab achieved immediate and sustained 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 observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. PhaseBio initiated the REVERSE-IT trial, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a Biologics License Application for bentracimab in both major bleeding and urgent surgery indications. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.

About PhaseBio

PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

PhaseBio is located in Malvern, PA, and San Diego, CA.

About Alfasigma

Privately owned, Alfasigma is an Italy based multinational pharmaceutical company, present in over 90 countries, through distributors and subsidiaries. The company employs a workforce of around 3,000 people, has in-house R&D capabilities, and several production plants. Alfasigma is known for its strong focus on Gastroenterology and Vascular.