Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease
company developing novel bile acid modulators, today announced that
it has entered into a definitive agreement to sell its Priority
Review Voucher (PRV) for $105 million. The PRV was granted to
Albireo under a U.S. Food and Drug Administration (FDA) provision
that encourages the development of treatments for rare pediatric
diseases. The Company received the voucher with the approval of
Bylvay for the treatment of pruritus in all types of progressive
familial intrahepatic cholestasis (PFIC).
“The sale of the PRV provides Albireo with an important source
of non-dilutive capital and further strengthens our balance sheet.
The proceeds allow us to continue our mission to ensure that all
diagnosed children with PFIC in the U.S. and Europe will have
access to Bylvay, progress two additional Bylvay Phase 3 studies
and advance two new product candidates,” said Ron Cooper, President
and Chief Executive Officer of Albireo. “We are proud that Bylvay
is our first approved product and the first approved therapy for
patients with PFIC.”
Albireo will receive a payment of $105 million upon the closing
of the transaction, which is subject to customary closing
conditions and is expected to occur following expiration of the
applicable U.S. antitrust clearance requirements.
Jefferies LLC acted as financial advisor to Albireo on this
transaction and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
acted as legal advisor.
The net sales proceeds expected from this transaction are in
addition to the $186.3 million in cash, cash equivalents and
short-term investments Albireo reported as of June 30, 2021.
About the Rare Pediatric Disease Priority Review Voucher
ProgramThe program is intended to encourage development of
new drug and biological products for prevention and treatment of
certain rare pediatric diseases. A PRV may be issued to the sponsor
of a rare pediatric disease product application and would entitle
the holder to priority review of a single New Drug Application or
Biologics License Application, which reduces the target review time
and could lead to an expedited approval. The sponsor receives the
PRV upon approval of the rare pediatric disease product application
and it can be sold without limitation, subject to applicable FDA
requirements for filing and use.
About Bylvay
(odevixibat)Bylvay is the first drug treatment
approved in the U.S. for the treatment of pruritus in all types of
progressive familial intrahepatic cholestasis (PFIC). The European
Commission (EC) has also granted marketing authorization of Bylvay
for the treatment of PFIC, which will be available for sale in
Europe following pricing and reimbursement approval. A potent,
once-daily, non-systemic ileal bile acid transport inhibitor,
Bylvay acts locally in the small intestine. Bylvay does not require
refrigeration and can be taken as a capsule for older children, or
opened and sprinkled onto food, which are factors of key importance
for adherence in a pediatric patient population. The medicine can
only be obtained with a prescription and treatment should be
started and supervised by a doctor who has experience in the
management of PFIC. For more information about using Bylvay, see
the package leaflet or contact your doctor or pharmacist. For full
prescribing information, visit www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan exclusivity for its
approved PFIC indications, and orphan designations for the
treatment of Alagille syndrome, biliary atresia and primary biliary
cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2
open-label trial in patients with PFIC, in the BOLD Phase 3 study
for patients with biliary atresia and the ASSERT Phase 3 study for
Alagille syndrome. The ASSERT and BOLD studies remain on track to
report topline data in 2022 and 2024 respectively.
About AlbireoAlbireo Pharma is a rare disease
company focused on the development of novel bile acid modulators to
treat rare pediatric and adult liver diseases. Albireo’s product,
Bylvay, was approved by the U.S. FDA as the first drug for the
treatment of pruritus in all types of progressive familial
intrahepatic cholestasis (PFIC), and is also being developed to
treat other rare pediatric cholestatic liver diseases with Phase 3
trials in Alagille syndrome and biliary atresia, as well as an
Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has
been approved for the treatment of PFIC and has been submitted for
pricing and reimbursement approval. The Company has also initiated
a Phase 1 clinical trial for A3907 to advance development in adult
cholestatic liver disease, with IND-enabling studies moving ahead
with A2342 for viral and cholestatic liver disease. Albireo was
spun out from AstraZeneca in 2008 and is headquartered in Boston,
Massachusetts, with its key operating subsidiary in Gothenburg,
Sweden. The Boston Business Journal named Albireo one of the 2020
Best Places to Work in Massachusetts for the second consecutive
year. For more information on Albireo, please visit
www.albireopharma.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: Albireo’s commercialization
plans and expectations for commercializing Bylvay in the U.S. and
Europe; estimates of the number of patients impacted by PFIC;
expectations about Bylvay’s acceptance by healthcare practitioners
to treat PFIC patients; the timing of the closing of the sale of
Albireo’s Rare Pediatric Disease Priority Review Voucher; the plans
for, or progress, scope, cost, initiation, duration, enrollment,
results or timing for availability of results of, development of
Bylvay, A3907, A2342 or any other Albireo product candidate or
program; the pivotal trial for Bylvay in biliary atresia (BOLD),
and the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the
Phase 1 trial for A3907; 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
long-term open-label extension study for Bylvay in PFIC, and the
BOLD and ASSERT trials; discussions with the FDA or EMA regarding
our programs; the potential benefits or competitive position of
Bylvay or any other Albireo product candidate or program or the
commercial opportunity in any target indication; the potential
effects of Bylvay of the treatment of PFIC patients and its
potential to improve the current standard of care; the potential
benefits of an orphan drug designation; the length of time for
which Albireo’s cash resources are expected to be sufficient, and
the milestones and activities to be funded with those cash
resources; 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,” or the negative of these terms or other 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: there are no guarantees that Bylvay will be
commercially successful; we may encounter issues, delays or other
challenges in launching or commercializing Bylvay; whether Bylvay
receives adequate reimbursement from third-party payors; the degree
to which Bylvay receives acceptance from patients and physicians
for its approved indication; challenges associated with execution
of our sales activities, which in each case could limit the
potential of our product; results achieved in Bylvay in the
treatment of patients with PFIC may be different than observed in
clinical trials, and may vary among patients; other potential
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 Bylvay to date, including findings in
indications other than PFIC, will be predictive of results from
other clinical trials of Bylvay; 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 Bylvay, including BOLD and ASSERT, and the Phase 1 clinical
trial of A3907, and the outcomes of such trials; Albireo’s ability
to obtain coverage, pricing or reimbursement for approved products
in the United States or Europe; delays or other challenges in the
recruitment of patients for, or the conduct of, Company’s clinical
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.
Media Contact: Colleen
Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLauren
Sneider, 857-300-1737, lauren.sneider@albireopharma.com
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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