Portola Pharmaceuticals Announces Results of CHMP Oral Explanations for Andexanet Alfa and Betrixaban
20 Février 2018 - 10:47PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has communicated a positive trend
vote on the Marketing Authorisation Application (MAA) for andexanet
alfa, a Factor Xa-inhibitor reversal agent, and a negative trend
vote for betrixaban, an oral, once-daily Factor Xa inhibitor.
Portola will host a webcast and conference call
on Tuesday, February 20, 2018 at 5:00 p.m. ET (2:00 p.m. PT) to
provide additional details on the regulatory status of both
products in Europe.
Andexanet Alfa
“We are very pleased with the favorable outcome
of the oral explanation for andexanet alfa, and remain confident in
our path forward to approval,” said Bill Lis, chief executive
officer of Portola. “The Committee has requested additional data,
which could delay the CHMP opinion until the fourth quarter, but we
will be working with the CHMP in the coming weeks to further
clarify their request and the impact on timing. In the meantime, we
look forward to presenting important new data from the ANNEXA-4
trial during a late-breaker session at next month’s American
College of Cardiology meeting.”
Portola is seeking conditional approval for
andexanet alfa for the reversal of the anticoagulant effects of the
Factor Xa inhibitors apixaban and rivaroxaban in patients
experiencing uncontrolled or life-threatening bleeding.
Andexanet alfa is also currently under review by
the U.S. Food and Drug Administration (FDA) with an anticipated
action date of May 4, 2018. New interim data from the Company’s
ongoing Phase 3b/4 trial of andexanet alfa (ANNEXA-4) will be
presented on Monday, March 12, 2018 during a Late-Breaking Clinical
Trial Session at the American College of Cardiology’s 67th
Annual Scientific Session & Expo (ACC.18).
Betrixaban
The CHMP communicated a negative trend vote for
betrixaban for the prevention of venous thromboembolism (VTE) in
adult patients hospitalized for an acute medical illness with risk
factors for VTE. A negative trend vote means it is unlikely that
the CHMP will adopt a positive opinion on the Company’s MAA at the
formal CHMP decision vote scheduled for March 2018, and that
additional steps would be needed to gain marketing approval in
Europe.
The CHMP’s position is that betrixaban efficacy
is acknowledged in the APEX trial, but uncertainties remain
regarding a positive benefit risk, which is not supported by a
second confirmatory study, biological plausibility for betrixaban
in another approved indication or external support within the class
from other Factor Xa inhibitors, which are not approved for the
acute medically ill population.
The FDA approved betrixaban in June 2017 under
the trade name Bevyxxa®.
“We are disappointed with the Committee’s
interpretation on betrixaban given the unmet medical need, the
clinically meaningful outcomes of the APEX trial and the broad
label we received to treat acute medically ill patients in the
U.S.,” said Lis. “We are considering our next steps in Europe. In
the meantime, we remain focused on the U.S. launch of Bevyxxa. As
the first and only anticoagulant approved as a single-drug regimen
from hospital admission to home (35-42 days) to prevent major
thromboembolic events related to VTE, Bevyxxa has the potential to
have a major public health impact on millions of patients in the
U.S. and beyond.”
Conference Call DetailsThe live
conference call, scheduled for Tuesday, February 20, 2018 at 5:00
p.m. ET, can be accessed by phone by calling (844) 452-6828 from
the United States and Canada, or 1 (765) 507-2588 internationally,
and using the passcode 2966018. The webcast can be accessed live on
the Investor Relations section of the Company's website
at http://investors.portola.com. It will be archived for 30
days following the call.
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’s first medicine Bevyxxa® (betrixaban), an oral,
once-daily Factor Xa inhibitor, was approved by the U.S. Food
and Drug Administration in June 2017. The company is also
working to advance two clinical programs for 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 http://www.portola.com and
follow the Company on Twitter @Portola_Pharma.
Forward-Looking StatementsThis
announcement contains forward-looking statements, including
statements relating to Portola Pharmaceuticals’ expectations
regarding the regulatory status of betrixaban and andexanet alfa.
These statements are subject to significant risks and
uncertainties, and actual results could differ materially from
those projected. These risks and uncertainties include,
without limitation, risks and uncertainties related to the
regulatory process for betrixaban and andexanet alfa in
Europe. Risks and uncertainties relating to Portola
Pharmaceuticals and its business can be found in the “Risk
Factors” section of Portola Pharmaceuticals’ Quarterly Report on
Form 10-Q for the third quarter of 2017, which was filed with
the SEC on November 9, 2017. Portola
Pharmaceuticals cautions investors not to place undue reliance
on the forward-looking statements contained in this release.
Portola Pharmaceuticals undertakes no duty or obligation to
update any forward-looking statements contained in this release as
a result of new information, future events or changes in Portola
Pharmaceuticals’ expectations.
Investor Contact:
Cara Miller
Portola
PharmaceuticalsIR@portola.com
Media
Contact:
Laurie Masonson W2O Group
lmasonson@w2ogroup.com
Portola Pharmaceuticals (NASDAQ:PTLA)
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