Portola Pharmaceuticals Enters into $50 Million Loan Agreement with Bristol-Myers Squibb and Pfizer for Continued Development...
December 19 2016 - 8:00AM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced it has
signed a $50 million loan agreement with Bristol-Myers Squibb
Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) that provides
additional funding toward development and clinical studies of
AndexXa™ (andexanet alfa), an investigational compound that is a
potential antidote for Factor Xa inhibitors.
“This agreement reflects the commitment and support of the
andexanet alfa program by our long-standing partners BMS and Pfizer
and helps Portola to continue moving rapidly toward our goal of
gaining regulatory approval in 2017,” said Tao Fu, chief commercial
and business officer of Portola. “We are committed to working with
the FDA to bring AndexXa to market as patients currently have no
approved antidote available to reverse Factor Xa inhibitors.”
Under the terms of the agreement, Bristol-Myers Squibb and
Pfizer will each loan Portola $25 million. The principal and
interest will be repaid primarily through royalties on AndexXa
commercial sales. No shares, warrants, options or other equity
components were or will be issued in connection with the loan. The
non-secured loan does not involve any transfer of patent ownership
or licenses.
AndexXa, a U.S. Food and Drug Administration (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 due
to life-threatening or uncontrolled bleeding. On August 17,
2016, Portola received a Complete Response Letter from
the FDA regarding its Biologics License Application for
AndexXa. Portola expects to resubmit the BLA in 2017.
Portola previously entered into two separate clinical
collaboration agreements with Bristol-Myers Squibb and Pfizer to
support Phase 2 and registrational studies of andexanet alfa in the
United States and Europe. Bristol-Myers Squibb and Pfizer also have
a collaboration agreement with Portola to develop and commercialize
andexanet alfa in Japan. Portola retains all rights, including full
commercial and financial rights, for andexanet alfa outside of
Japan.
About AndexXa 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.
AndexXa is currently being evaluated in the ongoing Phase 3b/4
ANNEXA™-4 study in patients with Factor Xa inhibitor-associated
acute major bleeding. Results of a preliminary analysis of interim
data were presented in a Late-Breaking Science Hot Line session at
the European Society of Cardiology 2016 Congress and
published simultaneously online by The New England Journal of
Medicine.
In the EU, the European Medicines Agency (EMA) is reviewing the
Marketing Authorization Application for andexanet alfa for reversal
of Factor Xa inhibition in patients experiencing a life-threatening
or uncontrolled bleed and for patients requiring urgent or
emergency surgery. A decision is expected in 2017.
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 the timing of
our development efforts for andexanet alfa and the projected need
for a Factor Xa inhibitor antidote. Risks that contribute to the
uncertain nature of the forward-looking statements include the risk
that our data fail to demonstrate safety and efficacy of andexanet
alfa to the satisfaction of the FDA or similar regulatory
authorities outside the United States, such as the EMA, and the
risks that we will not successfully manufacture andexanet alfa on a
commercial scale or be able to obtain the capital needed 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 November 7, 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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