Portola Pharmaceuticals Announces Dr. Robert Califf Retires From the Board of Directors to Accept Position as Deputy Commissi...
26 Janvier 2015 - 5:52PM
Portola Pharmaceuticals (Nasdaq:PTLA) announced that Robert Califf,
M.D., has retired from Portola's Board of Directors. Dr. Califf has
accepted a position as the Deputy Commissioner for Medical Products
and Tobacco at the FDA, as announced today in a press release
issued by the agency. Dr. Califf was first elected to Portola's
Board of Directors in 2012.
"On behalf of the Company, I want to thank Rob for his
invaluable contribution in helping to advance Portola's
groundbreaking clinical trials program across our pipeline,
including the novel biomarker-based Phase 3 APEX study of
betrixaban," said Bill Lis, chief executive officer at Portola. "We
would like to congratulate Rob on his new leadership position at
the FDA, where we know he'll continue to have a major impact on the
field of medicine for the benefit of patients."
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 of its potentially life-saving
therapies. Portola's partnered program is focused on developing
selective Syk inhibitors for inflammatory conditions.
Betrixaban
Portola's wholly-owned, oral, once-daily Factor Xa inhibitor
betrixaban is being evaluated in the only biomarker-based Phase 3
study for hospital-to-home prophylaxis of venous thromboembolism
(VTE) in acute medically ill patients. Betrixaban's distinct
properties may have the potential to allow the agent to demonstrate
efficacy without the significant increase in the rate of major
bleeding that was seen in this patient population with other Factor
Xa inhibitors. If approved, betrixaban could be the first
anticoagulant for both hospital and post-discharge VTE prophylaxis
and the standard of care in this large market of more than 20
million patients in the G7 countries
alone.
Andexanet Alfa
Andexanet alfa, a recombinant modified human Factor Xa molecule,
has the potential to be a first-in-class antidote to reverse the
effects of Factor Xa inhibitors in patients who suffer a major
bleeding episode or who require emergency surgery. Andexanet alfa
has been designated as a breakthrough therapy by the FDA. Portola
has entered into Phase 3 clinical collaboration agreements with all
of the manufacturers of direct Factor Xa inhibitors –
Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer
HealthCare and Janssen Pharmaceuticals (XARELTO® [rivaroxaban]),
and Daiichi Sankyo (edoxaban) – while retaining all commercial
rights to andexanet alfa. The Company is currently evaluating
andexanet alfa in the Phase 3 ANNEXA™ (Andexanet Alfa a Novel
Antidote to the Anticoagulant Effects of fXA Inhibitors)
registration studies.
Cerdulatinib
Portola's product candidate in the area of hematologic cancer,
cerdulatinib, is an orally available molecule that uniquely
inhibits two validated tumor proliferation pathways – spleen
tyrosine kinase (Syk) and janus kinase (JAK). It is currently being
evaluated in a Phase 1/2 proof-of-concept study in patients with B
cell leukemias or lymphomas with a focus on genetically-defined
subtypes, as well as in patients who have failed therapy due to
relapse or acquired mutations.
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:
Portola's plans for future clinical studies, timing of clinical
study results, future regulatory filings, and the potential
efficacy, safety and activity of Portola's product candidates.
Risks that contribute to the uncertain nature of the
forward-looking statements include: the accuracy of Portola's
estimates regarding its ability to initiate and/or complete its
clinical trials; the success of Portola's clinical trials and the
demonstrated efficacy of Portola's product candidates thereunder;
the accuracy of Portola's estimates regarding its expenses and
capital requirements; Portola's ability to manufacture andexanet
alfa; regulatory developments in the United States and foreign
countries; Portola's ability to obtain and maintain intellectual
property protection for its product candidates; and the loss of 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 and most recent Quarterly Report on Form
10-Q. 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.
CONTACT: Investor Contact:
Alexandra Santos
Portola Pharmaceuticals
ir@portola.com
650.246.7239
Media Contact:
Joey Fleury
BrewLife
jfleury@brewlife.com
415.946.1090
Portola Pharmaceuticals (NASDAQ:PTLA)
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