Alfasigma Acquires the European Llicense for Bentracimab from PhaseBio
PR90193
BOLOGNA, Italy, June 22, 2021 /PRNewswire=KYODO JBN/--
-- The agreement covers the countries of the European Union, the European
Economic Area, the United Kingdom, Ukraine, Russia and the CIS
-- Bentracimab is a human monoclonal antibody fragment to counteract the
antiplatelet effects of ticagrelor
-- After the recent acquisition of Lumeblue(R), Alfasigma's pipeline is
enriched with a biotechnological drug
Alfasigma has entered into an exclusive licensing agreement with PhaseBio
Pharmaceuticals, Inc. (Nasdaq: PHAS), for the commercialization of bentracimab
in 49 countries across Europe and other key markets.
Logo - https://mma.prnewswire.com/media/1325576/Alfasigma_Logo.jpg
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(R) / Brilique(R) (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(R). 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. ( http://www.phasebio.com/ ) 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.
For more information, please visit: www.phasebio.com, and follow Twitter
@PhaseBio and LinkedIn (
https://www.linkedin.com/company/phasebio-pharmaceuticals/ ).
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.
More information is available at the corporate website:
SOURCE: Alfasigma
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