SOUTH SAN FRANCISCO, Calif.,
Aug. 6, 2019 /PRNewswire/
-- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA)
today announced the Company's first sales of Ondexxya®
(andexanet alfa) in Europe. These
sales mark the initiation of commercial access in Europe to Ondexxya – the first and only
reversal agent approved for adult patients treated with the Factor
Xa inhibitors rivaroxaban or apixaban when reversal of
anticoagulation is needed due to life-threatening or uncontrolled
bleeding.
Portola is executing a phased
launch of Ondexxya in Europe, with
an initial focus on Germany,
Austria, the United Kingdom, the
Netherlands, Sweden,
Denmark and Finland, where Factor Xa inhibitor use, and
related bleeds, are among the highest in Europe.
"The number of Europeans taking a Factor Xa inhibitor is nearly
double that of the U.S. and continues to grow at a significant
rate. The speed with which these first European orders were
received and the number of medical societies that have already
added Ondexxya to their guidelines speaks to the potential unmet
need and demand for Ondexxya," said Scott
Garland, Portola's
president and chief executive officer. "We are pleased to now be
providing European clinicians with this important new medicine and
to have the opportunity to impact hundreds of thousands of
lives."
"As the first and only Factor Xa reversal agent approved in
Europe to address life-threatening
bleeds associated with apixaban or rivaroxaban, Ondexxya represents
a significant step forward in patient care," said Gerwin Winter, senior vice president and
Portola's head of Europe. "We look forward to continuing
discussions with individual reimbursement authorities and further
expanding access to Ondexxya in Europe."
The worldwide use of Factor Xa inhibitors is rapidly growing
because of their efficacy and safety profile compared to warfarin
and enoxaparin in preventing and treating thromboembolic conditions
such as stroke, pulmonary embolism and venous thromboembolism
(VTE). This growth has come with a related increase in the
incidence of hospital admissions and deaths related to bleeding,
the major complication of anticoagulation. Prior to its approval in
Europe, international guidelines
from the American College of Chest Physicians (CHEST) and the
European Society of Cardiology (ESC) recommended Ondexxya for
first-line use based on its clinical attributes. Ondexxya is now
recognized in nine European medical society guidelines, including
the European Stroke Organisation.
The European Commission (EC) granted conditional Marketing
Authorization for Ondexxya in Europe in April
2019. It was approved by the U.S. Food and Drug
Administration (FDA) in May 2018 under the FDA's
Accelerated Approval pathway and is marketed by Portola in the U.S. under the trade name
Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo].
About Ondexxya
Ondexxya is a recombinant protein
specifically designed to bind to Factor Xa inhibitors and rapidly
reverse their anticoagulant effect. Ondexxya is a modified form of
the human Factor Xa molecule, an enzyme that helps blood clot. It
works by acting as a decoy for oral and injectable Factor Xa
inhibitors, which target and bind to Factor Xa. When Ondexxya
is given to a patient with Factor Xa inhibitor-related bleeding, it
binds to the Factor Xa inhibitor and prevents it from inhibiting
the activity of Factor Xa and reverses the anticoagulant effects of
the inhibitor.
Please refer to full SmPC for further information on side
effects reported with Ondexxya.
For additional Important Safety Information and Andexxa's full
Prescribing Information, please visit http://www.Andexxa.com.
IMPORTANT INFORMATION FOR ANDEXXA [coagulation factor Xa
(recombinant), inactivated-zhzo]
BOXED WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC
ARREST AND SUDDEN DEATHS
See full prescribing information for
complete boxed warning
Treatment with Andexxa has been associated with serious and
life‑threatening adverse events, including:
- Arterial and venous thromboembolic events
- Ischemic events, including myocardial infarction and
ischemic stroke
- Cardiac arrest
- Sudden deaths
Monitor for thromboembolic events and initiate
anticoagulation when medically appropriate. Monitor for symptoms
and signs that precede cardiac arrest and provide treatment as
needed.
About Portola Pharmaceuticals, Inc.
Portola
Pharmaceuticals is a global, commercial-stage biopharmaceutical
company focused on the discovery, development and commercialization
of novel therapeutics that could significantly advance the fields
of thrombosis and other hematologic conditions. The Company's first
two commercialized products are Andexxa [coagulation factor Xa
(recombinant), inactivated-zhzo], marketed in Europe as Ondexxya (andexanet alfa), and
Bevyxxa® (betrixaban). The company also is advancing
cerdulatinib, a SYK/JAK inhibitor being developed for the treatment
of hematologic cancers. Founded in 2003 in South San Francisco, California, Portola has operations in the United States and Europe.
Forward-Looking Statements
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 anticipated launch timing and strategy for
Ondexxya in Europe and potential
treatment benefits of Ondexxya. Risks that contribute to the
uncertain nature of the forward-looking statements include: the
risk that physicians, patients and payers may not see the benefits
of utilizing Ondexxya for the indications which it is approved; our
ability to continue to manufacture our products and to expand
approved manufacturing facilities; the possibility of unfavorable
results from additional clinical trials involving Ondexxya; the
risk that Portola may not obtain
additional regulatory approvals necessary to expand approved
indications for Ondexxya; our expectation that we will incur losses
for the foreseeable future and will need additional funds to
finance our operations; the accuracy of our estimates regarding
expenses and capital requirements; our ability to successfully
build a hospital-based sales force and commercial infrastructure;
our ability to obtain and maintain intellectual property protection
for our products and 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 annual report on Form 10-K and 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.
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SOURCE Portola Pharmaceuticals, Inc.®