Alfasigma has
entered into an exclusive licencing with PhaseBio Pharmaceuticals,
Inc. (Nasdaq: PHAS), for the commercialisation of bentracimab in 49 countries
between Europe and other key markets. PhaseBio is
a biopharmaceutical company focused on the development and commercialisation 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,
showed an immediate and prolonged reversal of the antiplatelet effects of
Brilinta® / Brilique® (ticagrelor).
Under the terms of the licencing
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 US company will be responsible for
developing bentracimab and obtaining approval from the European Medicines
Agency (EMA) and the Medicines and Healthcare products Regulatory Agency
(MHRA). Subsequently, the marketing authorisation 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 be committed to respond to
the best of our possibilities. In addition to being proud to be able to address
a relevant population of patients, we are confident that we are bringing an
important and valuable medicine to the Alfasigma specialist product portfolio”, said Pier
Vincenzo Colli, CEO of Alfasigma. “This
agreement marks another important step in our journey to consolidate Alfasigma
among the main specialty companies on an international level, 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 commercialisation agreement with our
new partner, Alfasigma, is a very important opportunity for PhaseBio", said Jonathan
P. Mow, CEO of PhaseBio Pharmaceuticals. “Alfasigma brings a 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 pivotal 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."
Colli concludes: "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,
multi-centre, open-label, prospective single-arm study, designed to investigate
the reversal of the antiplatelet effects of ticagrelor with bentracimab both in
patients with uncontrolled or life-threatening major bleeding and in those
requiring urgent surgery or the application of invasive procedures. Previously,
bentracimab was studied in phase 1 and phase 2 clinical trials and demonstrated
the potential to provide life-saving therapeutic benefits through the immediate
and prolonged reversal of ticagrelor antiplatelet activity, potentially
alleviating the concerns connected to the 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.
