Portola Pharmaceuticals Announces Presentation of Interim Results from Phase 3b/4 ANNEXA™-4 Study of AndexXa™ (andexanet ...
26 Août 2016 - 2:00PM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced that
interim results from its ongoing Phase 3b/4 ANNEXA™-4 trial of
AndexXa™ (andexanet alfa), a Factor Xa inhibitor antidote, will be
featured in an oral Late-Breaking Science Hot Line session at the
European Society of Cardiology (ESC) 2016 Congress, which will take
place from August 27–31 in Rome. The data also will be featured in
the ESC’s Hot Line – Preventive Strategies II press conference on
Tuesday, August 30, at 9:00 a.m. CEST.
Portola will host an investor event, which will be webcast, on
Tuesday, August 30, at 5:00 p.m. CEST, following the ANNEXA-4
interim results presentation at the ESC Congress. Members of
Portola’s senior management team, together with Dr. Stuart J.
Connolly, ANNEXA-4 Executive Committee chairman, and Dr. C. Michael
Gibson, ANNEXA-4 Executive Committee member, will present and
discuss the data.
Following are details of the oral presentation, which will
include additional data not available in the posted abstract.
Abstract Title: ANNEXA-4 – Andexanet alfa for
reversal of Factor Xa inhibitors in patients with acute major
bleedingPresenting Author: Stuart J. Connolly,
M.D., professor, Department of Medicine, Faculty of Health
Sciences, McMaster University, Hamilton, Ontario Session
Title: Hot Line Preventive Strategies,
2Presentation Date and Time: Tuesday, August 30,
2:18–2:36 p.m. CESTLocation: Fiera di Roma
Exhibition and Trade Centre, Rome – Main Auditorium
Investor Event Webcast Information
The investor event will take place from 5:00-6:00 p.m. CEST/11
a.m.-12 p.m. EDT on Tuesday, August 30, and will be simultaneously
webcast. To access the live and subsequently archived webcast, go
to the Investor Relations section of the company's website at
http://investors.portola.com. A replay will be available for 30
days following the live event.
About AndexXa AndexXa, 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.
A U.S. Food and Drug Administration (FDA)-designated
Breakthrough Therapy, AndexXa 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 (CRL) from the FDA regarding its Biologics License
Application (BLA) for AndexXa. The Company plans to meet with the
FDA as soon as possible in order to resolve the outstanding
questions in the CRL and determine appropriate next steps.
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 potential future regulatory
approval of andexanet alfa and patient populations that could
benefit from a Factor Xa inhibitor reversal agent. 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 such approval, 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
Current Report on 8-K filed on August 19, 2016, and 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
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024