Portola Pharmaceuticals Enters Into Clinical Collaboration Agreement with Daiichi Sankyo to Develop Andexanet Alfa with Edoxa...
04 Avril 2016 - 2:00PM
Portola Pharmaceuticals (NASDAQ:PTLA), announced today that it has
entered into a clinical collaboration agreement with Daiichi Sankyo
to develop andexanet alfa as an antidote for edoxaban, Daiichi
Sankyo’s Factor Xa inhibitor, in Japan.
Portola is developing andexanet alfa, a U.S. Food and Drug
Administration (FDA)-designated Breakthrough Therapy, for patients
treated with a direct or indirect Factor Xa inhibitor when reversal
of anticoagulation is needed, such as for life-threatening or
uncontrolled bleeding or emergency surgery and urgent
procedures.
Under the terms of the agreement with Daiichi Sankyo, Portola
will receive an upfront payment and is eligible to receive an
additional milestone payment based on Japanese Ministry of Health,
Labor and Welfare (MHLW) approval of andexanet alfa as an antidote
for edoxaban. Daiichi Sankyo will provide technical support and
fund all clinical studies of andexanet alfa with edoxaban in Japan.
Daiichi Sankyo will receive no commercial or financial rights under
this agreement.
This agreement follows recent agreements with Bristol-Myers
Squibb (BMS), Pfizer Inc. and Bayer Healthcare to develop and
commercialize andexanet alfa in Japan. Under those agreements, BMS
and Pfizer will be responsible for development, regulatory and
commercial activities for andexanet alfa in Japan. Bayer will fund
development of andexanet alfa as an antidote for rivaroxaban in
Japan. Under this new agreement with Daiichi Sankyo, edoxaban will
also be included in the andexanet alfa clinical development program
in Japan.
Portola previously entered into eight separate non-exclusive
clinical collaboration agreements with Daiichi Sankyo, BMS, Pfizer,
Bayer and Janssen to support Phase 2 and Phase 3 studies of
andexanet alfa and edoxaban in the United States, Europe and Japan.
Portola may receive additional payments under these agreements.
Portola retains all rights, including full commercial and financial
rights, for andexanet alfa outside of Japan.
About the Need for a Factor Xa Inhibitor
Antidote
Commensurate with the increase in use of Factor Xa inhibitors,
the number of hospital admissions due to bleeding associated with
these agents continues to grow. Annually, 1 to 4 percent of
patients treated with Factor Xa inhibitors may experience major
bleeding, and an additional 1 percent may require emergency
surgery.
In Japan, three oral Factor Xa inhibitors are currently on the
market – Daiichi Sankyo’s edoxaban, BMS and Pfizer’s apixaban, and
Bayer HealthCare’s rivaroxaban. Based on data from IMS Health, in
the 12 months ending September 2015, sales of these novel oral
anticoagulants in Japan exceeded $800 million. There is an unmet
need for an antidote for some patients.
About Andexanet Alfa
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 allowing for the
restoration of normal hemostatic processes. Andexanet alfa is the
only compound being studied as an antidote for Factor Xa inhibitors
that directly and specifically corrects anti-Factor Xa activity –
the anticoagulant mechanism of these agents.
Portola’s Biologics License Application (BLA) for andexanet alfa
was accepted for filing by the FDA’s Center for Biologics
Evaluation and Research (CBER) and assigned a Prescription Drug
User Fee Act (PDUFA) date of August 17, 2016.
The BLA was based on data from preclinical, Phase 1 and 2,
manufacturing and Phase 3 studies. The Phase 3 ANNEXA™ (Andexanet
Alfa a Novel Antidote to the Anticoagulant Effects of FXa
Inhibitors) studies evaluated the safety and efficacy of andexanet
alfa in reversing the anticoagulant activity of the Factor Xa
inhibitors rivaroxaban and apixaban in healthy volunteers. Results
of those studies were published by The New England Journal of
Medicine in November 2015. The BLA also included limited
adjudicated efficacy and safety data from initial patients enrolled
in the ongoing Phase 4 ANNEXA-4 study. Portola is currently
evaluating andexanet alfa in this global, single-arm, open-label
confirmatory study in patients receiving apixaban, rivaroxaban,
edoxaban or enoxaparin (a low molecular weight heparin and indirect
Factor Xa inhibitor) who present to the hospital with an acute
major bleed.
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 its three programs using novel biomarker and genetic
approaches that may increase the likelihood of clinical, regulatory
and commercial success of its potentially life-saving therapies.
These programs include betrixaban, an oral, once-daily Factor Xa
inhibitor; 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 Statement
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
clinical and commercial development plans for andexanet alfa in
Japan. Risks that contribute to the uncertain nature of the
forward-looking statements include: failure to obtain FDA approval
for one or more of our product candidates; our expectation that we
will incur losses for the foreseeable future and will need
additional funds to finance our operations; the results of our
clinical trials related to the efficacy and safety of our product
candidates; our potential inability to manufacture andexanet alfa
on a commercial scale in a timely or cost-efficient manner; the
accuracy of our estimates regarding expenses and capital
requirements; the ability of us and our partners to successfully
execute under our collaboration agreements; regulatory developments
in the United States and foreign countries; 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 Portola's most recent filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K,
which was filed on February 29, 2016. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Portola undertakes 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
Portola Pharmaceuticals (NASDAQ:PTLA)
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