Albireo Announces Royalty Monetization Agreement with HealthCare Royalty Partners for Elobixibat in Japan
January 03 2018 - 8:00AM
— Albireo subsidiary eligible to receive up to
$60 million under agreement —
Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced that subsidiary Elobix AB has entered
into an agreement with HealthCare Royalty Partners (HCR) to
monetize its royalty rights under its license agreement with EA
Pharma Co., Ltd. for elobixibat in the treatment of chronic
constipation in Japan. EA Pharma is a subsidiary of Eisai Co, Ltd.
“We believe the commitment shown through this agreement by
HealthCare Royalty Partners, a leading healthcare investment firm,
provides additional validation for the therapeutic promise of ileal
bile acid transporter (IBAT) inhibition. The transaction is
designed to provide significant nondilutive capital for Albireo if
elobixibat is approved in Japan, allowing us to further strengthen
our cash position as we focus on the development of our lead
product candidate A4250,” said Ron Cooper, President and Chief
Executive Officer of Albireo. “We expect to initiate a Phase 3
trial of A4250, an IBAT inhibitor, in patients with the orphan
pediatric cholestatic liver disease progressive familial
intrahepatic cholestasis (PFIC) by the spring of this year.”
Under the terms of the agreement with HCR, Albireo subsidiary
Elobix will receive $45 million if elobixibat is approved by the
Japanese Ministry of Health, Labour and Welfare (MHLW) and is
eligible to receive an additional $15 million upon achievement of a
specified sales milestone. In return, HCR obtains the right to
receive royalties and sales milestones for elobixibat in Japan that
may become payable by EA Pharma, up to a specified threshold. If
the specified threshold is reached, Elobix will again become
eligible to receive royalties and sales milestones for elobixibat
under the terms of its license agreement with EA Pharma. Elobix has
retained its right to receive a milestone payment from EA Pharma if
elobixibat is approved by the MHLW.
As previously announced, EA Pharma submitted a new drug
application for elobixibat to treat chronic constipation in Japan
in February 2017, following highly statistically significant
results from a Phase 3 clinical trial in Japan. If approved by the
MHLW, elobixibat would become the first IBAT inhibitor approved
anywhere in the world.
“HCR is pleased to invest in elobixibat, as it presents an
exciting opportunity to bring a novel, dual-activity therapy to
chronic constipation patients in Japan,” said John Urquhart,
Principal of HCR.
About Elobixibat Elobixibat is a
first-in-class product candidate to treat chronic idiopathic
constipation (or, in Japan, chronic
constipation). Elobixibat is an inhibitor of the ileal bile
acid transporter (IBAT, and also sometimes referred to as the
apical sodium-dependent bile acid transporter) in the terminal
ileum to increase secretion and motility in the large bowel without
negatively affecting important functions in the small intestine.
Elobixibat has been evaluated to date in more than 1,000 healthy
volunteers and chronic constipation patients worldwide. A new drug
application has been submitted to the Japanese Ministry of
Health, Labour and Welfare for elobixibat for the
treatment of chronic constipation in Japan.
About HealthCare Royalty Partners HCR 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 $3.5 billion in cumulative capital
commitments with offices in Stamford (CT), San Francisco, Boston
and London. For more information,
visit www.healthcareroyalty.com.
About AlbireoAlbireo Pharma is a clinical-stage
biopharmaceutical company focused through its operating subsidiary
on the development of novel bile acid modulators to treat orphan
pediatric liver diseases and other liver and gastrointestinal
diseases and disorders. Albireo’s clinical pipeline includes a
Phase 3 product candidate, a Phase 2 product candidate and a
product candidate for which an application for regulatory approval
has been submitted in Japan. Albireo was spun out from AstraZeneca
in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key
operating subsidiary is located in Gothenburg, Sweden. For more
information on Albireo, please visit www.albireopharma.com.
Forward-Looking StatementsThis 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: the timing for the
decision whether to approve the new drug application for elobixibat
in Japan; any payments that HealthCare Royalty Partners (HCR) or EA
Pharma may make to Albireo or its subsidiaries and the effect of
any such payments on Albireo’s cash position; the commercial
prospects for elobixibat in Japan; plans for A4250, including the
timing for initiation of the planned Phase 3 clinical trial in
patients with PFIC; 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 and uncertainties, including, but not limited to,
risks and uncertainties relating to: whether the new drug
application submitted by EA Pharma in Japan for elobixibat for the
treatment of chronic constipation in Japan will be approved and, if
so, when; if approved, the extent of market acceptance and
commercial success of elobixibat in Japan; the occurrence of any
event, change or other circumstances that could give rise to the
termination of the royalty monetization agreement with HCR without
payment to Albireo or its subsidiaries; whether the sales milestone
specified in the royalty monetization agreement with HCR for
elobixibat in Japan will be achieved; whether the threshold of
royalties and sales milestones for elobixibat in Japan specified in
the royalty monetization agreement with HCR after which Elobix
would again become eligible to receive royalties and sales
milestones for elobixibat under the terms of its license agreement
with EA Pharma will be achieved; the significant control that EA
Pharma has over the commercialization of elobixibat in Japan; the
timing for initiation of the planned Phase 3 trial of A4250 in
patients with PFIC; and whether changes made in the process of
finalizing the protocol for the planned Phase 3 trial of A4250 in
patients with PFIC result in a delay in its initiation. 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 and in other 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.
212-915-2568
Media Contact:Heather Anderson6
Degrees980-938-0260handerson@6degreespr.com
Source: Albireo Pharma, Inc.
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