Portola Pharmaceuticals Announces Resubmission of Biologics License Application for AndexXa® (Andexanet Alfa)
03 Août 2017 - 10:13PM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced that on
August 3, 2017 it resubmitted its Biologics License Application
(BLA) to the Center for Biologics Evaluation and Research (CBER) of
the U.S. Food and Drug Administration (FDA) for AndexXa® (andexanet
alfa), a reversal agent for Factor Xa inhibitors. The resubmission
includes supplemental information primarily related to
manufacturing, as requested by the FDA in a complete response
letter (CRL) issued to Portola in August 2016.
AndexXa, an FDA-designated Breakthrough Therapy, is in
development for patients treated with a direct (apixaban,
rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa
inhibitor when reversal of anticoagulation is needed to address
uncontrolled or life-threatening bleeding. In the U.S., in 2016
approximately 90,000 patients treated with oral Factor Xa
inhibitors were admitted to the hospital due to bleeding. Including
patients taking the injectable Factor Xa inhibitor enoxaparin, it
is estimated that more than 150,000 U.S. patients could benefit
from an antidote annually. Currently, there are no approved Factor
Xa inhibitor antidotes.
About AndexXa®
(Andexanet Alfa) AndexXa®
(andexanet alfa), an investigational drug, is a modified human
Factor Xa molecule that acts as a decoy to target and sequester
with high specificity both oral and injectable Factor Xa inhibitors
in the blood. Once bound, the Factor Xa inhibitors are unable to
bind to and inhibit native Factor Xa, thus potentially allowing for
the restoration of normal hemostatic processes. AndexXa is the
first compound being studied as an antidote for Factor Xa
inhibitors that directly and specifically reverses anti-Factor Xa
activity – the anticoagulant mechanism of these agents.
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’s
first medicine Bevyxxa® (betrixaban), an oral,
once-daily Factor Xa inhibitor, was approved by the U.S. Food and
Drug Administration in June 2017. The company is also working to
advance two clinical programs for AndexXa®
(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 http://www.portola.com and follow the Company on Twitter
@Portola_Pharma.
Forward-looking StatementsStatements 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, AndexXa’s potential as a Factor Xa inhibitor antidote
and the projected response time of the FDA to the resubmission of
our BLA for AndexXa. Risks that contribute to the uncertain nature
of the forward-looking statements include: failure to
obtain FDA and/or EMA approval for AndexXa, regulatory
developments in the United States and foreign countries;
our potential inability to manufacture our product candidates on a
commercial scale in a timely or cost-efficient manner; our ability
to successfully build a hospital-based sales force and commercial
infrastructure; our ability to obtain and maintain intellectual
property protection for our product candidates; and our ability to
retain key scientific or management personnel. These and other
risks and uncertainties are described more fully in our most recent
filings with the Securities and Exchange Commission, including
our most recent quarterly report on Form 10-Q. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investors:
Mardi Dier, Chief Financial Officer
Portola Pharmaceuticals
mdier@portola.com
650.246.7236
Media:
Julie Normart
Pure Communications
jnormart@purecommunications.com
415.946.1087
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