Portola Pharmaceuticals Supports “World Thrombosis Day” Campaign to Increase Awareness of Risks of Blood Clots
14 Octobre 2016 - 12:07AM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) is committed to raising
awareness of the incidence, risks and potentially life-threatening
complications of thrombosis (blood clots) and is serving as a
global partner for World Thrombosis Day, which is taking place
today.
According to the International Society on Thrombosis and
Haemostasis (ISTH), 1 in 4 people worldwide dies from conditions
related to thrombosis. In the United States alone, up to 900,000
people are affected by blood clots each year and about 100,000 of
them die – more than the total number of people who lose their
lives each year to AIDS, breast cancer and motor vehicle crashes
combined. Thrombosis is the underlying pathology of heart attack,
thromboembolic stroke and venous thromboembolism (VTE; a blood clot
that forms in a vein and breaks loose and travels in the
bloodstream) -- the top three cardiovascular killers. In many
cases, thrombosis is preventable.
Recent advances in the field of thrombosis have led to the
development of novel oral anticoagulants (NOACs) to prevent and
treat VTEs. NOACs are predominantly comprised of a class of drugs
called Factor Xa inhibitors, which are indicated to prevent stroke
and blood clots in people with atrial fibrillation; to treat and
prevent deep vein thrombosis (DVT) and pulmonary embolism (PE); and
to prevent DVT, which may lead to PE, following hip or knee
replacement surgery. In the United States, an estimated 2.5 million
people will be treated with a Factor Xa inhibitor this year. The
number of patients on Factor Xa inhibitors is currently growing at
a rapid rate of approximately 45 percent year-over-year.
Portola is unique in its dedication to helping patients with
issues related to thrombosis. It is addressing two significant
areas of unmet medical need with its two late-stage product
candidates: betrixaban, a Factor Xa inhibitor to prevent blood
clots in acute medically ill patients during hospitalization and
after discharge, and AndexXaTM (andexanet alfa), a Factor Xa
inhibitor antidote for patients with acute major
bleeding.
Patients hospitalized for serious, common medical conditions
(i.e., the acute medically ill) are at increased risk for VTE,
which is a major cause of morbidity, mortality and
re-hospitalization. An estimated 20 million acute medically ill
patients in the G7 countries are at risk of developing VTE, either
while in the hospital or following discharge. More than half of VTE
events among the acute medically ill occur after the patient is
discharged from the hospital. Despite the benefits provided by oral
Factor Xa inhibitors, none is currently FDA-approved or
guideline-recommended for prevention of VTE in acute medically ill
patients. Portola is addressing this growing, underserved patient
population with its investigational oral Factor Xa inhibitor
betrixaban. Betrixaban, an investigational agent, directly inhibits
the activity of Factor Xa, an important validated target in the
blood coagulation pathway, to prevent life-threatening thrombosis.
The Company has conducted a pivotal Phase 3 APEX Study of
betrixaban for the prevention of VTE in acute medically ill
patients in both the hospital and home setting, and published the
results in the New England Journal of Medicine. Portola expects to
submit a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for betrixaban before the end of the year.
While Factor Xa inhibitors are effective in preventing blood
clots, they can be associated with potentially life-threatening
acute major bleeding, including intracranial hemorrhage, in some
patients. As the use of Factor Xa inhibitors increases, the number
of patients hospitalized each year due to bleeding associated with
these agents continues to grow. At this time, no FDA-approved
antidote is available and no existing therapies have demonstrated
reversal of Factor Xa inhibitor activity or clinical efficacy and
safety. Portola is addressing this critical unmet need with its
investigational Factor Xa inhibitor antidote, AndexXa. 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. The Company
recently reported interim results from its Phase 3b/4 ANNEXA-4
study, which were published in the New England Journal of Medicine,
and expects to resubmit a Biologics License Application (BLA) for
AndexXa in 2017.
About the Need for an Oral Anticoagulant
for Extended-Duration Prevention of VTE in Acute Medically Ill
Patients Acute medically ill patients are
hospitalized for serious, common medical conditions, including
heart failure, stroke, infection and pulmonary disease. Because of
their underlying disorder or immobilization during hospitalization,
they are at increased risk of serious and potentially
life-threatening blood clots known as VTE. An estimated 20 million
acute medically ill patients in the G7 countries are at risk of
developing VTE, either while in the hospital or following
discharge. Each year, more than 1 million VTE events and 150,000
VTE-related deaths occur in acute medically ill patients in the G7
countries, despite the standard use of injectable enoxaparin and
other heparins in the hospital. More than half of VTE events occur
after the patient is discharged from the hospital. However, no
anticoagulant, including enoxaparin or any of the marketed oral
Factor Xa inhibitors, is approved for extended VTE prophylaxis in
the more than 24 million medically ill patients hospitalized in the
G7 countries annually.
About the Need for a Factor Xa Inhibitor
AntidoteAnnually, 1 to 4 percent of patients treated with
Factor Xa inhibitors may experience major bleeding, and an
additional 1 percent may require emergency surgery. Commensurate
with the increase in the use of Factor Xa inhibitors -- for stroke
prevention in atrial fibrillation; treatment and prevention of deep
vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT
following knee or hip replacement surgery -- the number of hospital
admissions due to bleeding associated with these agents continues
to grow. In the United States, more than 80,000 patients treated
with oral Factor Xa inhibitors were admitted to the hospital due to
bleeding during 2015. Including patients taking the injectable
Factor Xa inhibitor enoxaparin, it is estimated that more than
100,000 U.S. patients could benefit from an antidote annually.
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 three programs, including betrixaban, an
oral, once-daily Factor Xa inhibitor; 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 www.portola.com and follow the
Company on Twitter @Portola_Pharma.
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 development
of our product candidates and estimated timelines associated
therewith. Risks that contribute to the uncertain nature of the
forward-looking statements include the risk that we may be unable
to satisfy regulatory requirements for product approvals, and the
risk that the results from our APEX clinical trial may cause
betrixaban regulatory approval to be delayed, more costly or not be
obtained at all, we may be unable to manufacture andexanet alfa on
a commercial scale, and we will need additional capital to fund our
operations. 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, which was filed on August 9, 2016. 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.
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
415.946.1087
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