SOUTH SAN FRANCISCO, Calif.,
March 18, 2020 /PRNewswire/ --
Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today
announced proactive steps the Company is taking in support of
public heath efforts to prevent furtherspread of coronavirus (or
COVID-19) around the globe.
As this global pandemic evolves rapidly, Portola's first priority is the health and
safety of employees, patients and healthcare providers. To align
with growing rigorous regulations at the global, federal and local
level around the COVID-19 global pandemic, we have taken proactive
steps to help hospitals focus efforts where they are needed most
right now, and to ensure the health and safety of our
employees.
Effective March 13, we suspended
face-to-face field activity and instituted a mandatory work from
home policy for all employees, including those in our South San Francisco and European headquarters.
San Francisco and six surrounding
counties have been asked to "Shelter in Place" until April 7, and we anticipate our offices being
closed until that order is lifted. For our staff around the globe,
we are monitoring local government recommendations and adapting
plans accordingly.
While the coronavirus pandemic has led to suspended
activities and business around the world, it will not stop
patients who take rivaroxaban or apixaban from
experiencing life-threatening bleeds. To address these enduring
needs, we are shifting to a virtual field force to continue
engaging customers with digital tools and remote meetings where
possible. Our plan to present and publish data throughout the year
remains intact. We were pleased to announce the latest results of
real-world data demonstrating Andexxa® [coagulation
factor Xa (recombinant), inactivated-zhzo], was associated with the
lowest rate of mortality in patients with multiple types of
Factor Xa inhibitor-related bleeds. These data will be presented at
the virtual American College of Cardiology's Annual Scientific
Session together with the World Congress of Cardiology (ACC.20/WCC)
later this month. We will be using virtual meetings to actively
share these data and continue our education efforts to establish
Andexxa as the standard of care for patients.
"These are unprecedented times that have changed all aspects of
our daily lives and the way in which we conduct business. Now more
than ever is the time for us to come together to support healthcare
professionals working on the front line to prevent the further
spread of coronavirus," said Scott
Garland, Portola's
president and chief executive officer. "We admire their dedication
and believe our actions will support efforts to address this public
health crisis."
Additionally, it is important that we are able to continue to
supply hospitals with Andexxa. We have adequate supply of this
important medicine on-hand for the next couple of years in
the United States and Europe. At this time, the global Andexxa
supply chain and distribution structure is intact for customers to
continue to use and re-order Andexxa.
Portola will continue
to closely monitor this global situation and work with
suppliers, distributors, customers, clinical trial collaborators
and our employees to adjust strategies as it evolves.
About ANDEXXA
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo)
is a recombinant modified human factor Xa (FXa) protein indicated
for patients treated with rivaroxaban or apixaban, when reversal of
anticoagulation is needed due to life-threatening or uncontrolled
bleeding.
Important Safety Information
The most frequently reported adverse reactions in clinical
trials in healthy subjects with Andexxa were mild or moderate
infusion-related reactions comprising symptoms such as flushing and
feeling hot (very common), and cough, dysgeusia, and dyspnea
(common). Amongst bleeding patients, commonly reported side effects
were ischemic stroke and pyrexia, with uncommon reported side
effects of cerebral infarction, cerebrovascular accident, transient
ischemic attack, acute myocardial infarction, cardiac arrest,
myocardial infarction, deep vein thrombosis, iliac artery
occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more
information, including Boxed Warning,
at www.Andexxa.com.
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 Portola's
development plans, and the potential benefits of Andexxa. 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 Andexxa for the indications
for which it is approved; the risk that the ongoing global COVID-19
pandemic may negatively affect our employees and business and our
ability to serve patients; our ability to continue to manufacture
our products and to expand approved manufacturing facilities; the
possibility of unfavorable results from additional clinical trials
or other studies involving Andexxa; our ability to grow our
commercial operations in the EU and generate product revenue within
projected timelines and budget; the risk that we may not obtain
additional regulatory approvals necessary to expand approved
indications for Andexxa; 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 product candidates; our ability to retain key scientific or
management personnel and general market conditions. 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. 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.®