Portola Pharmaceuticals Announces Collaboration With Ora, Inc. for Syk-selective Inhibitor (PRT2761) in Ophthalmic Diseases
05 Mai 2015 - 2:01PM
Portola Pharmaceuticals (Nasdaq:PTLA) today announced a
collaboration with Ora, Inc. for the development of Portola's
highly selective Syk inhibitor, PRT2761, in ophthalmic diseases.
The inhibition of Syk may more completely prevent activation of
mast cells in ocular allergy and, therefore, a Syk inhibitor could
represent a promising therapeutic option.
"This collaboration for PRT2761 is part of a strategy that
allows us to advance early-stage compounds outside of our key focus
on thrombosis and hematologic cancer with innovative companies that
have the expertise and resources to develop these agents to
proof-of-concept. This collaboration provides us with the
flexibility and optionality to build significant pipeline value,"
said William Lis, chief executive officer of Portola. "Once we
achieve proof-of-concept with this asset, we will make a decision
on the potential value of the program and our interest in further
developing it."
"Portola's highly specific Syk inhibitor PRT2761 has the
potential to deliver rapid onset of action and comprehensive
treatment of both signs and symptoms of ocular allergy, including
redness, inflammation, swelling and itching," said Stuart B.
Abelson, president and chief executive officer of Ora. "We are
impressed by its properties and preclinical data, which
demonstrated activity in reducing conjunctival redness and
swelling, a key clinical sign of allergic conjunctivitis that is
not adequately treated by existing therapies."
Ora has a solid track record of successfully identifying and
developing technologies to advance the standard of care of allergic
eye disease. Over the past 30 years, Ora's preclinical and clinical
Ora-CAC™ models have demonstrated their utility in translation and
reproducibility leading to 20 ocular allergy drug approvals. Under
the collaboration agreement, Ora will lead the clinical development
of PRT2671, and the companies will share in the development
expenses until proof-of-concept is established. Portola retains
decision making oversight of the program.
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 programs are 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, an FDA-designated breakthrough therapy, is a
recombinant protein designed to reverse the anticoagulant effect in
patients treated with an oral or injectable Factor Xa inhibitor.
Andexanet alfa has the potential to be a first-in-class antidote
for anticoagulated patients who suffer a major bleeding episode or
require emergency surgery. Portola has entered into Phase 3
clinical collaboration agreements with all of the manufacturers of
direct Factor Xa inhibitors while retaining all commercial rights
to andexanet alfa. The Company is currently evaluating andexanet
alfa in the Phase 3 and Phase 4 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 1/2a 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.
About Ora, Inc.
Ora, Inc. is a global, full-service ophthalmic clinical research
and product development firm. Over the past 30 years, it has helped
clients earn 39 FDA approvals. Ora supports a wide array of
organizations, from start-ups to global pharmaceutical and device
companies, to efficiently and successfully bring their new products
from concept to market. Ora's pre-clinical and clinical models,
unique methodologies and regulatory strategies have been refined
and proven across thousands of projects both in the US and
internationally. Ora brings together the world's most extensive and
experienced network of ophthalmic experts and R&D professionals
in order to maximize the value of new product initiatives. For
additional information, please visit http://oraclinical.com.
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 for PRT2761, the
potential indications, efficacy, safety and activity of PRT2761,
and the potential market and indications for its other 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, which was filed on March 2, 2015. 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:
Michele Mantynen
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Joey Fleury
BrewLife
jfleury@brewlife.com
Portola Pharmaceuticals (NASDAQ:PTLA)
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