PhaseBio Announces Financing and Co-Development Collaboration with SFJ Pharmaceuticals® for PB2452
January 10 2020 - 9:00AM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced a financing and co-development collaboration with
SFJ Pharmaceuticals to support the development of PB2452, a
reversal agent for the antiplatelet therapy ticagrelor. SFJ
Pharmaceuticals is a global drug development company backed by
Blackstone Life Sciences and Abingworth.
The collaboration between SFJ and PhaseBio will
support the global development of PB2452, which is designed to
reverse the antiplatelet activity of ticagrelor in major bleeding
and urgent surgery situations. Under the terms of the agreement,
SFJ has agreed to fund up to $120 million to support the
clinical development of PB2452 and to assume a central role in
global clinical development and regulatory activities for PB2452
outside the United States. SFJ will fund up to $90 million of
development expenses through the end of 2021 and up to an
additional $30 million based on PhaseBio meeting specific,
pre-defined clinical milestones for PB2452.
“This innovative collaboration with SFJ provides
PhaseBio with substantial funding to continue the rapid advancement
of our lead program, PB2452, and enables us to efficiently extend
our global reach,” said Jonathan P. Mow, Chief Executive Officer of
PhaseBio. “SFJ’s global drug development and regulatory expertise,
coupled with a track record of success in accelerating and
advancing late-stage development programs for large, multi-national
pharmaceutical companies, make it an ideal partner. The
collaboration provides PhaseBio with financial flexibility while
allowing us to retain full commercial rights and mitigate our
global development risk.”
Under the terms of the PB2452 agreement, PhaseBio
will pay SFJ a series of annual payments over seven to eight years
following receipt of regulatory approvals in the United States, the
European Union and either China or Japan, with the majority of
payments to SFJ due in years three to seven following each
respective regulatory approval. If PB2452 does not receive
regulatory approval in a specific territory, PhaseBio will not owe
any payments linked to that territory. In general, the amount to be
repaid by PhaseBio will not exceed five times the amount funded by
SFJ. PhaseBio will retain exclusive worldwide commercial rights to
PB2452.
“We are excited to be partnering with PhaseBio
under this novel co-development agreement,” said Bob
DeBenedetto, Chief Executive Officer of SFJ. “Based on the
clinical data generated to date and following an extensive
diligence process conducted in conjunction with our partners at
Blackstone Life Sciences and Abingworth, we believe that PB2452 has
great potential to address a significant unmet need. We look
forward to supporting its continued development and working closely
with the PhaseBio team.”
About PB2452
PB2452 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, PB2452
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 antiplatelet drugs. The Phase 1 clinical
trial of PB2452 in healthy volunteers was published in the New
England Journal of Medicine in March 2019.1 In April 2019, PB2452
received Breakthrough Therapy designation from the FDA.
Breakthrough Therapy designation may be granted by FDA when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapy. PhaseBio
plans to initiate a single pivotal Phase 3 clinical trial of PB2452
in the first quarter of 2020 to support a BLA for PB2452 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. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies to treat cardiopulmonary
diseases. The company’s lead development candidate is PB2452, a
novel reversal agent for the antiplatelet therapy ticagrelor.
PhaseBio is also leveraging its proprietary elastin-like
polypeptide (“ELP”) technology platform to develop therapies with
the potential for less-frequent dosing and improved
pharmacokinetics. PhaseBio’s second product candidate PB1046, which
is based on ELP, is a once-weekly vasoactive intestinal peptide
receptor agonist for the treatment of pulmonary arterial
hypertension.
PhaseBio is located in Malvern, PA and San Diego,
CA. For more information, please
visit www.phasebio.com.
About the SFJ Pharmaceuticals
Group
SFJ is a global drug development company, which
provides a unique and highly customized co-development partnering
model for the world's top pharmaceutical and biotechnology
companies. SFJ provides at-risk funding and the global clinical
development management and oversight necessary for regulatory
submission for some of the most promising drug development programs
of Pharmaceutical and Biotechnology companies. SFJ’s mission is to
leverage its financial strength and global team of pharmaceutical
development experts to accelerate the development of life-saving
and life-enhancing drugs for the benefit of physicians and the
patients they serve.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “anticipates,” “believes,”
“expects,” “intends,” “projects,” and “future” or similar
expressions are intended to identify forward-looking
statements.
Forward-looking statements include statements
concerning or implying the success of our collaboration with SFJ,
including whether we will receive all of the contemplated funding
under the co-development agreement, the conduct or timing of our
clinical trials, timelines for regulatory submissions, the
potential for PB2452 to receive regulatory approval from the FDA or
equivalent foreign regulatory agencies and whether, if approved,
PB2452 will be successfully distributed and marketed and
our research, development and regulatory plans for PB2452,
PB1046 and our ELP research programs. Forward-looking statements
are based on management's current expectations and are subject to
various risks and uncertainties that could cause actual results to
differ materially and adversely from those expressed or implied by
such forward-looking statements. Accordingly, these forward-looking
statements do not constitute guarantees of future performance, and
you are cautioned not to place undue reliance on these
forward-looking statements.
Risks regarding our business are described in
detail in our Securities and Exchange Commission filings,
including in our Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019. These forward-looking statements
speak only as of the date hereof, and PhaseBio
Pharmaceuticals, Inc. disclaims any obligation to update these
statements except as may be required by law.
1 Bhatt DL, Pollack CV, Weitz JI, et al.
Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N
Engl J Med 2019; 380:1825-1833
Investor Contact:John
SharpPhaseBio Pharmaceuticals, Inc. Chief Financial Officer(610)
981-6506john.sharp@phasebio.com
Media Contact:Gina Cestari6
Degrees(917) 797-7904gcestari@6degreespr.com
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