The Italian Alfasigma puts a biotechnological drug into the pipeline. Thanks to an exclusive licensing agreement signed with the American PhaseBio, a biopharmaceutical company focused on the development and marketing of new therapies for cardiopulmonary diseases, the Bologna-based company acquires the rights to market bentracimab in 49 countries between Europe and other key markets. The experimental product is a human monoclonal antibody fragment that counteracts the antiplatelet effects of the antiplatelet ticagrelor, explains a note.
The agreement – it says – 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. Under the terms of the agreement, PhaseBio will receive an upfront payment of $ 20 million; may receive $ 35 million upon obtaining certain pre-market regulatory approvals, and up to $ 190 million upon achieving certain sales milestones, as well as certain tiered royalties on net sales.
The US company will be responsible for developing bentracimab and obtaining approval from the European Medicines Agency EMA and the UK Medicines and Health Products Regulatory Agency, Mhra. Subsequently, the marketing authorization will be assigned to Alfasigma. The latter will be responsible for obtaining approval in other territories not covered by Ema or Mhra authorizations, and for obtaining and maintaining the necessary approvals to market and sell the product, including price negotiations and post-market commitments. marketing.
Bentracimab is currently at an advanced stage of clinical development in the Reverse-It study, a phase 3 trial designed to investigate the reversal of the antiplatelet effects of ticagrelor with bentracimab in patients with uncontrolled or life-threatening major bleeding. , or requiring urgent surgery or invasive procedures. In Phase 1 and 2 studies, bentracimab demonstrated the potential to provide life-saving therapeutic benefits through immediate and prolonged reversal of ticagrelor antiplatelet activity, potentially alleviating concerns about bleeding risks associated with the use of the antiplatelet agent. Additionally, in a translational study, bentracimab achieved an equivalent reversal of brand name ticagrelor and multiple generics of ticagrelor.
“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 exploit our experience in key markets in Europe and Asia “, says Pier Vincenzo Colli, CEO of Alfasigma. “The needs of people with hospital diseases are one of our main focuses – he underlines – It is essential to understand the still unmet needs of patients and clinicians and, as in the case of bentracimab, commit ourselves to respond in the best possible way”.
“The signing of this commercialization agreement with our new partner, Alfasigma, is a very important opportunity for PhaseBio,” says Jonathan P. Mow, CEO of PhaseBio Pharmaceuticals – Alfasigma brings deep regional experience in the hospital environment, which will contribute unlocking 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. ”