Portola Pharmaceuticals (Nasdaq:PTLA) today announced that it has
entered into a second clinical collaboration agreement with
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE)
to study Portola's investigational Factor Xa inhibitor reversal
agent, andexanet alfa* (PRT4445), with the oral Factor Xa inhibitor
Eliquis® (apixaban). The original agreement, announced in November
2012, covered the conduct of a Phase 2 proof-of-concept study.
Results of the Phase 2 study were presented at the 2013 Congress of
the International Society on Thrombosis and Haemostasis (ISTH) and
demonstrated andexanet alfa's ability to produce an immediate and
either temporary or sustained reversal of the anticoagulation
activity of Eliquis. The new clinical collaboration agreement will
be in effect through Phase 3 studies with Eliquis and any potential
U.S. and EU regulatory approval of andexanet alfa. The Phase 3
studies are expected to start in the first half of 2014.
Under this non-exclusive collaboration agreement, Portola will
receive an upfront payment and is eligible to receive additional
development and regulatory milestone payments. Bristol-Myers Squibb
and Pfizer will continue to provide development and regulatory
guidance for the program. Portola retains full, worldwide
commercial rights to andexanet alfa, which was designated as a
breakthrough therapy by the U.S. Food and Drug Administration (FDA)
in November 2013 and for which Portola is pursuing an Accelerated
Approval pathway.
"We are pleased to continue our collaboration with Bristol-Myers
Squibb and Pfizer, which has been instrumental in accelerating
andexanet alfa's development as a potential agent to reverse the
anticoagulation effect of Eliquis," said William Lis, chief
executive officer of Portola. "The FDA's recent designation of
andexanet alfa as a breakthrough therapy recognizes the medical
need for this antidote as well as its attributes, which distinguish
it from general procoagulant approaches. Andexanet alfa is the only
agent that has been shown to reverse the anticoagulation effect of
Factor Xa inhibitors in humans."
Currently, millions of patients are treated with Factor Xa
inhibitors for short-term use or chronic conditions, and the
anticoagulant market is expected to continue to grow with the
adoption of novel oral anticoagulants. Clinical trial results
suggest that, depending on their underlying medical condition,
annually between 1 and 4 percent of these patients will experience
uncontrolled bleeding, and an additional 1 percent will require
emergency surgery.i Currently, there is no antidote or reversal
agent approved for use against Factor Xa inhibitors. Leading
clinicians have identified, and the FDA has recognized, the lack of
an effective reversal agent for Factor Xa inhibitors as a
significant unmet medical need.
About Andexanet Alfa* Andexanet alfa is a
first-in-class recombinant, modified Factor Xa molecule being
developed as a direct reversal agent (antidote) for patients
receiving a Factor Xa inhibitor who suffer an uncontrolled bleeding
episode or who require emergency surgery. Andexanet alfa acts as a
Factor Xa decoy that targets and sequesters with high specificity
both direct and indirect Factor Xa inhibitors in the blood. Once
bound, the Factor Xa inhibitors are unable to bind to and inhibit
native Factor Xa, thus allowing for the restoration of normal
hemostatic processes.ii Through its mechanism of action, andexanet
alfa has the potential to act as a universal antidote and address
the direct cause of the patient's inhibited clotting activity
without being prothrombotic.
Portola has entered into clinical collaboration agreements with
all of the manufacturers of direct Factor Xa inhibitors, while
retaining all rights to the program.
Portola has completed and reported data from a Phase 2
proof-of-concept study of andexanet alfa and Eliquis. Results
showed that andexanet alfa produces immediate, dose-dependent and
well-tolerated reversal of anti-Factor Xa activity. The reversal
can be either temporary through the administration of an
intravenous bolus or sustained by the addition of an extended
infusion. This is critical in covering the multiple clinical
scenarios in which a reversal agent would be needed, which could
include patients suffering major uncontrolled bleeding from trauma
or those needing emergency surgery.
Portola has also reported data from a Phase 2 proof-of-concept
study of andexanet alfa and XARELTO® (rivaroxaban).
The Phase 2 studies, which have included more than 80
volunteers, have shown that andexanet alfa is well tolerated, with
no thrombotic events, serious adverse events or antibodies to
Factor Xa or Factor X observed.
Additional Phase 2 proof-of-concept studies with the direct
Factor Xa inhibitors, betrixaban and SavaysaTM (edoxaban), and the
indirect Factor Xa inhibitor, enoxaparin, are either planned or
ongoing.
About Portola Pharmaceuticals, Inc. Portola
Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of novel therapeutics in the
areas of thrombosis and hematology.
Betrixaban Portola's wholly-owned lead compound, betrixaban, is
a novel, oral, once-daily Factor Xa inhibitor in Phase 3
development for extended-duration prophylaxis of venous
thromboembolism (VTE) in acute medically ill patients. Betrixaban's
properties may be uniquely suited to potentially demonstrate
efficacy without significantly increasing bleeding in this patient
population. Currently, there is no anticoagulant approved for
extended-duration VTE prophylaxis in acute medically ill patients.
Andexanet Alfa* Portola's second lead development candidate,
andexanet alfa (PRT4445), has the potential to be a first-in-class
universal antidote to directly reverse the effects of Factor Xa
inhibitors in patients who suffer an uncontrolled bleeding episode
or who require emergency surgery. Portola has entered into clinical
collaboration agreements with all of the manufacturers of direct
Factor Xa inhibitors, including Bristol-Myers Squibb and Pfizer
(Eliquis® [apixaban]), Bayer HealthCare and Janssen
Pharmaceuticals (XARELTO® [rivaroxaban]), and Daiichi Sankyo
(SavaysaTM [edoxaban]), while retaining all commercial rights to
the program. Andexanet alfa has been designated as a breakthrough
therapy by the U.S. Food and Drug Administration.
Cerdulatinib* (PRT2070) and PRT2607 Portola's third wholly-owned
product candidate, cerdulatinib (PRT2070), is an orally available
kinase inhibitor that uniquely inhibits two validated tumor
proliferation pathways -- spleen tyrosine kinase (Syk) and janus
kinase (JAK). It is currently being studied in patients with
leukemias or lymphomas with a focus on genetically-defined
subtypes, as well as in patients who have failed therapy due to
relapse or acquired mutations. Portola's fourth program is
partnered with Biogen Idec and is focused on the development of
PRT2607, a selective Syk inhibitor. For more information, visit
www.portola.com.
Forward-looking statement
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements
regarding: Portola's plans for future clinical studies and
pursuit of an Accelerated Approval process for andexanet alfa,
anticipated growth in the market for anticoagulants, and the
potential efficacy, safety and activity of andexanet alfa,
betrixaban and cerdulatinib. Risks that contribute to the uncertain
nature of the forward-looking statements include: the accuracy of
Portola's estimates regarding its ability to initiate and/or
complete its clinical trials; the success of Portola's clinical
trials and the demonstrated efficacy of Portola's product
candidates thereunder; the accuracy of Portola's estimates
regarding its expenses and capital requirements; regulatory
developments in the United States and foreign countries; Portola's
ability to obtain and maintain intellectual property protection for
its product candidates; and the loss of key scientific or
management personnel. These and other risks and uncertainties are
described more fully in Portola's most recent filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Portola undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
*Andexanet alfa and cerdulatinib are proposed International
Nonproprietary Names (pINN).
iRivaroxaban ROCKET (3.6% TIMI Major); Apixaban ARISTOTLE (2.1%
ISTH Major, 0.96 TIMI Major); Levi, Blood. 2008;111:4471-4476;
Circulation. 2012;126:343-348.
iiLu G, DeGuzman FR, Hollenbach SJ, Karbarz MJ, Abe K. A
specific antidote for reversal of anticoagulation by direct and
indirect inhibitors of coagulation factor Xa. Nature Medicine.
Published online March 3, 2013.
CONTACT: Investor Contact:
Alexandra Santos
Portola Pharmaceuticals
ir@portola.com
650.246.7239
Media Contact:
Joey Fleury
BrewLife
jfleury@brewlife.com
415.946.1090
Portola Pharmaceuticals (NASDAQ:PTLA)
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