Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced it has agreed to terms with Hercules
Capital, Inc. (NYSE: HTGC) on a debt facility to provide up to $80
million of new capital, and will receive $15M under a restructured
royalty monetization agreement with HealthCare Royalty Partners
(HCR) for elobixibat in the treatment of chronic constipation in
Japan. Elobixibat, approved in Japan for the treatment of patients
with chronic constipation, is the first ileal bile acid transporter
(IBAT) inhibitor approved anywhere in the world.
“These funding arrangements with new and existing partners
provide the company additional flexibility and cash runway into the
beginning of 2022, past the planned approval and commercial launch
of odevixibat for the treatment of progressive familial
intrahepatic cholestasis,” said Ron Cooper, President and
Chief Executive Officer of Albireo. “This strengthened financial
foundation will also enable our continued growth as we deliver on
additional odevixibat pivotal trials, NASH clinical development and
pre-clinical programs.”
Under the updated terms of the agreement with HCR, the company
will receive an additional $15 million on top of the $45 million
royalty financing commitment HCR made in 2018 for royalty rights
based on sales for elobixibat in the treatment of chronic
constipation in Japan. In exchange, the company eliminated the cap
on HCR’s rights to receive royalties on sales in Japan and sales
milestones for elobixibat in certain other territories that may
become payable by the Company’s partner, EA Pharma Co., Ltd..
Elobixibat is marketed and sold in Japan under the trade name
GOOFICE.
“HCR’s additional investment reinforces our view that
elobixibat’s unique mechanism of action results in a differentiated
product that provides a meaningful benefit to patients in Japan”,
said John Urquhart, Managing Director of HCR.
Under the terms of the new agreement with Hercules Capital,
Albireo may access up to $80 million of new capital, with an
initial minimum of $10 million drawn down on a first available
tranche of $15M, and additional tranches based on regulatory and
other milestones.
“Hercules is pleased to be partnering with Albireo and
supporting its clinical efforts which are focused on the
development of novel treatments for orphan pediatric liver
diseases, and other liver and gastrointestinal diseases and
disorders. This structured debt investment represents a significant
commitment from Hercules, and it is consistent with our goal of
supporting innovative life sciences companies through all stages of
development," said Kristen Kosofsky, Senior Managing Director at
Hercules.
About AlbireoAlbireo Pharma is a clinical-stage
biopharmaceutical company focused on the development of novel bile
acid modulators to treat orphan pediatric liver diseases, and other
liver and gastrointestinal diseases and disorders. Albireo’s lead
product candidate, odevixibat, is being developed to treat rare
pediatric cholestatic liver diseases and is in Phase 3 development
in progressive familial intrahepatic cholestasis (PFIC) and biliary
atresia, with a third Phase 3 trial being planned in Alagille
syndrome. Albireo’s clinical pipeline also includes two Phase 2
product candidates. Elobixibat is in Phase 2 development in NAFLD
and NASH. Approved in Japan for the treatment of chronic
constipation, elobixibat is the first ileal bile acid transporter
(IBAT) inhibitor approved anywhere in the world.
Albireo was spun out from AstraZeneca in
2008. Albireo Pharma is located in Boston, Mass.,
and its key operating subsidiary is located in Gothenburg,
Sweden. The Boston Business Journal named Albireo one of
the 2019 Best Places to Work in Massachusetts. For more
information on Albireo, please
visit www.albireopharma.com.
About HCRHealthCare Royalty Partners (“HCR") is
a private investment firm that purchases royalties and uses
debt-like structures to invest in commercial or near-commercial
stage biopharmaceutical assets. HCR has $5.5 billion in cumulative
capital commitments with offices in Stamford (CT), San Francisco,
Boston and London. For more information, visit
www.healthcareroyalty.com.
Forward-Looking Statements This press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of
1995. Forward-looking statements include statements, other
than statements of historical fact, regarding, among other things:
the plans for, or progress, scope, cost, initiation, duration,
enrollment, results or timing for availability of results of,
development of odevixibat, elobixibat or any other Albireo product
candidate or program, including regarding expectations regarding
the impact of COVID-19 on our business and our ability to adapt our
approach as appropriate; the Phase 3 clinical program for
odevixibat in patients with PFIC, the pivotal trial for odevixibat
in biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, the Phase 2 clinical trial for elobixibat in
NAFLD/NASH, and another Phase 3 trial for elobixibat being
conducted by EA Pharma in Japan; the target indication(s) for
development or approval, the size, design, population, location,
conduct, cost, objective, enrollment, duration or endpoints of any
clinical trial, or the timing for initiation or completion of or
availability or reporting of results from any clinical trial,
including the Phase 3 PFIC trial for odevixibat, and the long-term
open-label extension study, the pivotal trial for odevixibat in
biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, or the Phase 2 trial for elobixibat in
NAFLD/NASH; the potential approval and commercialization of
odevixibat; discussions with the FDA or EMA regarding our programs;
the potential benefits or competitive position of odevixibat,
elobixibat, or any other Albireo product candidate or program or
the commercial opportunity in any target indication; the potential
benefits of an orphan drug designation; the period for which
Albireo’s cash resources will be sufficient to fund its operating
requirements (runway); or Albireo’s plans, expectations or future
operations, financial position, revenues, costs or
expenses. Albireo often uses words such as “anticipates,”
“believes,” “plans,” “expects,” “projects,” “future,” “intends,”
“may,” “will,” “should,” “could,” “estimates,” “predicts,”
“potential,” “planned,” “continue,” “guidance,” and similar
expressions to identify forward-looking statements. Actual results,
performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to: negative impacts of the COVID-19 pandemic,
including on manufacturing, supply, conduct or initiation of
clinical trials, or other aspects of our business; whether
favorable findings from clinical trials of odevixibat to date,
including findings in indications other than PFIC, will be
predictive of results from the trials comprising the Phase 3 PFIC
program or any other clinical trials of odevixibat; whether either
or both of the FDA and EMA will determine that the
primary endpoint for their respective evaluations and treatment
duration of the double-blind Phase 3 trial in patients with PFIC
are sufficient, even if the primary endpoint is met with
statistical significance, to support approval of odevixibat
in the United States or the European Union, to treat
PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise;
the outcome and interpretation by regulatory authorities of the
ongoing third-party study pooling and analyzing of long-term PFIC
patient data; the timing for initiation or completion of, or for
availability of data from, clinical trials of odevixibat, including
the trials comprising the Phase 3 PFIC program, the pivotal program
in biliary atresia or the planned pivotal program in Alagille
syndrome, and the outcomes of such trials; Albireo’s ability to
obtain coverage, pricing or reimbursement for approved products
in the United States or European Union; delays or
other challenges in the recruitment of patients for, or the conduct
of, the double-blind Phase 3 trial or other pivotal trials; and
Albireo’s critical accounting policies. These and other risks and
uncertainties that Albireo faces are described in greater detail
under the heading “Risk Factors” in Albireo’s most recent Annual
Report on Form 10-K or in subsequent filings that it makes with
the Securities and Exchange Commission. As a result of risks
and uncertainties that Albireo faces, the results or events
indicated by any forward-looking statement may not occur. Albireo
cautions you not to place undue reliance on any forward-looking
statement. In addition, any forward-looking statement in this press
release represents Albireo’s views only as of the date of this
press release and should not be relied upon as representing its
views as of any subsequent date. Albireo disclaims any obligation
to update any forward-looking statement, except as required by
applicable law.
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC, 617-430-7578Media Contact: Claire
LaCagnina, 6 Degrees, 315-765-1462, clacagnina@6degreespr.com
Source: Albireo Pharma, Inc.
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