Portola Pharmaceuticals Signs $150 Million Royalty Agreement with HealthCare Royalty Partners for Development and Commerciali...
03 Février 2017 - 2:00PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
it has signed a $150 million royalty agreement with HealthCare
Royalty Partners (HCR). Under the terms of the agreement, Portola
received $50 million at closing and may receive an additional $100
million upon U.S. Food and Drug Administration (FDA) approval of
AndexXaTM (andexanet alfa) in exchange for a tiered,
mid-single-digit royalty based on worldwide sales of the agent. The
agreement is subject to a maximum total royalty payment of 195
percent of the $150 million funded by HCR, at which time the
agreement would expire.
“We are looking forward to partnering with HCR on this
financing, which will provide us with capital to fund our
operations in a non-dilutive manner and successfully launch this
potentially life-saving agent for the benefit of tens of thousands
of patients,” said Bill Lis, chief executive officer of
Portola.
“We are very pleased to partner with Portola to help fund the
development and commercialization of andexanet alfa. Once approved,
it will be the first antidote available for the increasing number
of patients admitted to the hospital with a major bleeding episode
who currently have no options to reverse the effect of
anticoagulation,” said Dr. Warren Cooper, chief medical officer and
managing director at HCR.
Clarke Futch, managing partner and chairman of HCR’s Investment
Committee added, “This transaction provides capital to Portola to
further the development and commercialization of andexanet alfa,
which we believe will have a significant impact on the lives of
affected patients.”
Portola will use the proceeds for continued clinical and
regulatory activities and for planned development and
commercialization of andexanet alfa, an FDA-designated Breakthrough
Therapy. Andexanet alfa is in development as a potential antidote
for Factor Xa inhibitors. Portola received a Complete Response
Letter from the FDA regarding its Biologics License Application for
andexanet alfa in August 2016, and expects to resubmit the
application in the first half of 2017. In the EU, the European
Medicines Agency is reviewing the Marketing Authorization
Application for andexanet alfa.
About HealthCare Royalty PartnersHCR is a
private investment firm that purchases royalties and uses debt-like
structures to invest in commercial or near-commercial stage life
science assets. HCR has $3.4 billion in cumulative capital
commitments with offices in Stamford (CT), San Francisco and
Boston. Over the past decade, HCR's senior professionals have
completed more than 60 healthcare investments. For more
information, visit www.healthcareroyalty.com.
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 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 development of our product
candidates, our regulatory applications and estimated timelines
associated therewith. Risks that contribute to the uncertain nature
of the forward-looking statements include: failure to obtain
regulatory approval for one or more of our product candidates,
failure to achieve U.S. FDA approval in a timely and sufficient
manner to receive the additional $100 million in funding from HCR,
whether or not there will be sales of or royalties on andexanet
alfa, our belief that the funds will be sufficient to fund our
operations, our expectation that we will incur losses for the
foreseeable future and needs for additional funds to commercialize
one or more of our product candidates; the results of our clinical
trials related to the efficacy and safety of our product
candidates; our potential inability to manufacture our product
candidates on a commercial scale in a timely or cost-efficient
manner; the accuracy of our estimates regarding expenses and
capital requirements; 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 most recent quarterly report on Form 10-Q, which was
filed on November 7, 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
Pure Communications
jnormart@purecommunications.com
415.946.1087
Portola Pharmaceuticals (NASDAQ:PTLA)
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