Portola Pharmaceuticals Enters Into Licensing Agreements for Investigational Agent Andexanet Alfa in Japan Worth Up to $120 M...
01 Février 2016 - 12:55PM
Portola Pharmaceuticals (NASDAQ:PTLA), announced today that it has
licensed lead development and commercial rights to its
investigational agent andexanet alfa in Japan to Bristol-Myers
Squibb Company and Pfizer Inc. to be developed as an antidote for
apixaban and other Factor Xa inhibitors. Separately, Portola has
entered into a clinical collaboration agreement with Bayer
HealthCare to include its Factor Xa inhibitor rivaroxaban in this
clinical development program in Japan.
Three oral Factor Xa inhibitors are currently on the market in
Japan – Bristol-Myers Squibb and Pfizer’s apixaban, Bayer
HealthCare’s rivaroxaban, and Daiichi Sankyo’s edoxaban – but an
antidote is not yet approved. A universal antidote for Factor Xa
inhibitors is needed for certain patients in Japan, as the clinical
use of these novel oral anticoagulants is growing.
“These agreements allow Portola to expand the development and
commercialization of andexanet alfa into Japan, which is a new
country for us and the third largest market for Factor Xa
inhibitors after the United States and EU 5 countries,” said
William Lis, chief executive officer of Portola. “Bristol-Myers
Squibb, Pfizer and Bayer all have extensive infrastructure and
experience in Japan. With Bristol-Myers Squibb and Pfizer leading
development and commercialization activities and Bayer providing
support, the path forward for andexanet alfa as a Factor Xa
inhibitor antidote in Japan will be accelerated.”
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 in life-threatening or
uncontrolled bleeding or for emergency surgery/urgent procedures.
Portola retains full, worldwide commercial rights to andexanet alfa
outside of Japan.
Bristol-Myers Squibb and Pfizer Agreement
DetailsUnder the terms of the agreement with Bristol-Myers
Squibb and Pfizer, Portola will receive an upfront payment of $15
million and is eligible to receive potential regulatory and
sales-based milestone payments totaling $90 million, as well as
double-digit royalties based on andexanet alfa net sales in Japan.
Bristol-Myers Squibb and Pfizer will be responsible for all
development and regulatory activities for andexanet alfa in Japan
and for commercializing the drug in Japan, assuming it receives
regulatory approval from the Japanese Ministry of Health, Labor and
Welfare (MHLW).
Portola previously entered into two separate non-exclusive
clinical collaboration agreements with Bristol-Myers Squibb and
Pfizer to support Phase 2 and Phase 3 development of andexanet alfa
and apixaban in the United States and EU. Portola may receive
additional milestone payments under these agreements based on
developments in the United States and EU. Portola has completed a
Biologics License Application (BLA) submission with the FDA and is
awaiting acceptance for filing. The FDA assigned a PFUDA date of
August 17, 2016, under an Accelerated Approval pathway. Portola
plans to submit an EU application in 2017. Bristol- Myers Squibb
and Pfizer continue to provide development and regulatory guidance
to Portola for the andexanet alfa program in the United States and
the EU.
Bayer Agreement DetailsUnder the terms of the
Bayer Clinical Collaboration agreement, Portola will receive an
upfront payment of $5 million and is eligible to receive an
additional milestone payment based on Japanese MHLW approval of
andexanet alfa as an antidote for rivaroxaban. Bayer will provide
technical support as well as fund clinical studies of andexanet
alfa with rivaroxaban in Japan. Bayer will receive no commercial
rights under this agreement.
Portola previously entered into two separate non-exclusive
clinical collaboration agreements with Bayer HealthCare and its
development partner, Janssen Pharmaceuticals, Inc. to support Phase
2 and Phase 3 studies of andexanet alfa and rivaroxaban in the
United States and Europe. Portola may receive additional milestone
payments under these agreements based on developments in the United
States and EU.
About the Need for a Factor Xa Inhibitor
AntidoteCommensurate 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. Currently, use of the Factor Xa inhibitor class
in Japan is substantial and growing. Based on data from IMS Health,
in the 12 months ending September 2015, sales of novel oral
anticoagulants in Japan were more than $800 million. There is an
unmet need for an antidote for some patients.
About Andexanet AlfaAndexanet 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.
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 wholly-owned programs using novel biomarker and genetic
approaches that may increase the likelihood of clinical, regulatory
and commercial success. These programs include betrixaban, an oral,
once-daily Factor Xa inhibitor being evaluated in the APEX Phase 3
study for prophylaxis of venous thromboembolism; 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.
Portola Forward-looking StatementsStatements
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:
potential payments that may be received by Portola under these
licensing agreements; the potential of these licensing arrangements
to accelerate the development and commercialization of andexanet
alfa in Japan; the potential of the availability of an antidote to
affect prescribing behavior for Factor Xa inhibitors; continued
receipt by Portola of development and regulatory support from our
collaboration partners; increasing use of Factor Xa inhibitors and
associated increase in patients requiring an antidote; andexanet
alfa’s potential to treat patients needing reversal of Factor Xa
anticoagulation effects, the projected number of patients that
could benefit from andexanet alfa; the potential for andexanet alfa
to become the first universal antidote for Factor Xa inhibitors;
our plans for pursuit of regulatory approval of andexanet alfa, and
the likelihood of clinical, regulatory and commercial success for
andexanet alfa and our other product candidates. Risks that
contribute to the uncertain nature of the forward-looking
statements include: our expectation that we will incur losses for
the foreseeable future and will need additional funds to finance
our operations; we enter into collaborations that place certain
aspects of the development of andexanet alfa out of our direct
control; the pace of enrollment in our clinical trials; the results
of our clinical trials related to the efficacy and safety of our
product candidates; the risk that regulatory approval of our
product candidates may not be received in a timely manner, or at
all; our potential inability to manufacture andexanet alfa and our
other product candidates on a commercial scale in a timely or
cost-efficient manner; the accuracy of estimates regarding our
expenses and capital requirements; our ability to successfully
build a hospital-based sales force and commercial infrastructure;
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 our most recent filings
with the Securities and Exchange Commission, including our Annual
Report on Form 10-K, which was filed on March 2, 2015, and
Quarterly Report on Form 10-Q for the third quarter of 2015, which
was filed on November 9, 2015. 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
Portola Pharmaceuticals (NASDAQ:PTLA)
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