-- 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