Portola Pharmaceuticals Announces FDA Grants Fast Track Designation to Betrixaban for Prevention of Blood Clots in Acute Medi...
13 Octobre 2015 - 2:00PM
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation to betrixaban for extended-duration prevention of
venous thromboembolism (VTE), or blood clots, in acute medically
ill patients (i.e., those who are hospitalized for serious medical
conditions, such as heart failure, stroke, infection and pulmonary
disease). Betrixaban is an investigational oral anticoagulant that
directly inhibits the activity of Factor Xa, an important validated
target in the blood coagulation pathway, to prevent
life-threatening thrombosis.
Portola is currently evaluating betrixaban in the global,
pivotal, 7,500-patient Phase 3 APEX (Acute Medically Ill VTE
Prevention with Extended Duration Betrixaban) Study for the
prevention of VTE in acute medically ill patients. The Company
expects to complete patient enrollment in APEX by the end of 2015
and report top-line data in the first quarter of 2016. If the trial
is successful, the Company expects to submit a New Drug Application
(NDA) later in 2016 under the Fast Track designation.
The FDA’s Fast Track process is designed to facilitate the
development and expedite the review of drugs used to treat serious
conditions and fill an unmet medical need. Fast Track designation
enables a company to have early and frequent communication with the
FDA throughout the drug development and review process, often
leading to earlier drug approval.
“FDA’s Fast Track designation of betrixaban recognizes the unmet
medical need in the prevention of VTE in acute medically ill
patients. Importantly, it raises public awareness of this
life-threatening condition in a large, underserved patient
population. Betrixaban has the potential to become the first
anticoagulant approved for extended-duration prevention of VTE,”
said John T. Curnutte, M.D., Ph.D., executive vice president,
research and development, for Portola. “We’re now focused on
completing the APEX trial and reporting results in early 2016.”
About the APEX Study
The Phase 3 APEX Study is evaluating the superiority of
extended-duration anticoagulation with oral betrixaban (for 35-42
days) compared with standard of care anticoagulation with
injectable enoxaparin (for up to 14 days) for the prevention of VTE
in acute medically ill patients. The study is being conducted at
450 clinical sites worldwide. APEX is using a biomarker-based trial
design to identify and enroll patients who are at highest risk of
VTE and most likely to benefit from betrixaban – specifically those
with an elevated level of D-dimer (a protein fragment present after
a blood clot has developed) and those over age 75. The APEX Study
is the only biomarker-based Phase 3 study for hospital-to-home
prophylaxis of VTE in acute medically ill patients. It is also the
only pivotal thrombosis trial evaluating a single anticoagulant for
VTE prophylaxis in both the in-hospital and post-discharge
settings.
About Betrixaban
Betrixaban is an investigational oral, Factor Xa inhibitor
anticoagulant. Betrixaban has distinct properties that may allow it
to demonstrate clinical benefit without the significant imbalance
in the risk of fatal bleeding seen with other agents in the class.
These include a 19-25-hour half-life for once-daily dosing; a low
peak-to-trough drug concentration ratio that minimizes
anticoagulant variability; low renal clearance; and no significant
CYP3A4 metabolism, which may reduce the risk of drug-drug
interactions.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company
developing product candidates that could significantly advance the
fields of thrombosis and other hematologic diseases. The Company is
advancing its three wholly-owned programs using novel biomarker and
genetic approaches that may increase the likelihood of clinical,
regulatory and commercial success of its potentially life-saving
therapies. These programs include betrixaban, an oral, once-daily
Factor Xa inhibitor being evaluated in the APEX Phase 3 study for
prophylaxis of venous thromboembolism (VTE); andexanet alfa, a
recombinant protein designed to reverse the anticoagulant effect in
patients treated with an oral or injectable Factor Xa inhibitor;
and cerdulatinib, a Syk/JAK inhibitor in development to treat
hematologic cancers. Portola's partnered program is focused on
developing selective Syk inhibitors for inflammatory conditions.
For more information, visit www.portola.com and follow the Company
on Twitter @Portola_Pharma.
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 the
potential advantages of Fast Track designation, timing of patient
enrollment in APEX and reporting of topline APEX results, the
potential for betrixaban to become the first oral anticoagulant
approved for both in-hospital and post-discharge prevention of VTE,
including properties of betrixaban that may allow it to demonstrate
a clinical benefit without the significant imbalance in the risk of
fatal bleeding seen with other agents in the class. 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 to the satisfaction of regulatory
authorities; the accuracy of Portola's estimates regarding its
expenses and capital requirements; Portola's ability to manufacture
andexanet alfa; 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,
including its Annual Report on Form 10-K, which was filed on March
2, 2015, and Quarterly Report on Form 10-Q, which was filed on
August 5, 2015. 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.
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
Portola Pharmaceuticals (NASDAQ:PTLA)
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