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:

https://www.alfasigma.com.

SOURCE: Alfasigma