Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company
developing novel bile acid modulators, entered into an exclusive
licensing agreement with Jadeite Medicines, Inc. for the
development and commercialization of Bylvay (odevixibat) in Japan
for progressive familial intrahepatic cholestasis (PFIC), Alagille
syndrome (ALGS) and biliary atresia.
Under the terms of the agreement, Albireo will receive an
upfront payment of $15M and will be eligible to receive up to $120M
in milestones as well as double-digit royalties. Jadeite Medicines,
a biopharmaceutical platform company focused on developing global
innovative pharmaceutical products for Japan, will be responsible
for clinical development, regulatory approval and commercialization
of Bylvay in Japan, where there is significant market opportunity.
Jadeite Medicines is backed by CBC Group (www.cbridgecap.com), who
has partnered with the world’s top entrepreneurs and scientists
and, leveraging its unique “investor-operator” approach, has
empowered global leading healthcare companies to widen access to
affordable medical care, catalyze innovations and improve
efficiency in fulfilling unmet medical needs worldwide.
“This agreement exemplifies Albireo’s commitment to providing
global availability of Bylvay, particularly in areas like Japan
where high prevalence translates to a sizable number of patients
who currently have no approved treatment option. Jadeite Medicines
entrepreneurial, biotech approach makes them the right type of
partner to successfully commercialize Bylvay in Japan,” said Ron
Cooper, President and Chief Executive Officer of Albireo. “The
agreement allows for success of both companies, while strengthening
Albireo’s financial position with the $15M payment added to our
strong balance sheet.”
Bylvay is the first drug approved in Europe for the treatment of
all types of PFIC and in the U.S. for the treatment of pruritus in
all types of PFIC. A potent, non-systemic ileal bile acid transport
inhibitor (IBATi), Bylvay is administered as a once-daily capsule
or opened and sprinkled onto soft foods. Bylvay is currently being
evaluated in the ASSERT Phase 3 study for ALGS, the BOLD Phase 3
study for patients with biliary atresia and the ongoing PEDFIC 2
open-label trial in patients with PFIC.
“We are excited to partner with Albireo to accelerate delivery
of odevixibat to children living with rare liver diseases,
initially targeting PFIC, followed by potentially biliary atresia
and Alagille syndrome, which all represent significant unmet
medical needs in Japan,” said Eiichi Takahashi, M.D., Ph.D., Chief
Executive Officer of Jadeite Medicines. “This agreement reinforces
Jadeite’s commitment and vision to develop highly differentiated
and innovative medicines to improve the health and quality of life
of patients in Japan.”
“CBC remains steadfast in our commitment to widening access to
medical care globally, and Jadeite is our cornerstone in Japan, and
the partnership with Albireo represents important progress toward
that goal by expanding more cure options, initially for children
living with rare liver diseases in Japan,” said Sean Cao, Ph.D.,
Managing Director of CBC Group. “By leveraging our extensive
investor-operator experience in Asia, we will continue to partner
with the world’s top pharmaceutical companies and scientists and
identify opportunities to broaden global reach for patients with
unmet medical needs.”
About Bylvay
(odevixibat)Bylvay is the first drug approved in
the U.S. for the treatment of pruritus in patients 3 months of age
and older in all types of progressive familial intrahepatic
cholestasis (PFIC). The European Commission (EC) and UK Medicines
and Healthcare Products Regulatory Agency (MHRA) have also granted
marketing authorization of Bylvay for the treatment of PFIC in
patients aged 6 months or older. Bylvay is available for sale in
Germany and will be available for sale in other European countries
following pricing and reimbursement approval. A potent, once-daily,
non-systemic ileal bile acid transport inhibitor, Bylvay acts
locally in the small intestine. Bylvay 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.
About JadeiteJadeite Medicines is a
biopharmaceutical company focused on developing and commercializing
innovative pharmaceutical products that address critical unmet
medical needs for patients in Japan. The management team of Jadeite
Medicines has deep expertise and an extensive track record of
high-quality clinical development, regulatory affairs, CMC,
business development and operations in Japan and with leading
global pharmaceutical companies. Jadeite Medicines plans to build a
portfolio of global first-in-class or best-in-class molecules, many
of which are in late-stage clinical development. For more
information, please visit its website
at www.jadeitemedicines.co.jp.
About CBCCBC Group, Asia’s largest
healthcare-dedicated investment firm, commits to creating value and
integrating global resources. In partnering with the world’s top
entrepreneurs and scientists, our unique “investor-operator”
approach has empowered global leading healthcare companies to widen
access to affordable medical care, catalyze innovations, and
improve efficiency in fulfilling unmet medical needs worldwide.
Founded in 2014, CBC has a leading team of investment, industry and
portfolio management professionals headquartered in Singapore with
global offices in Shanghai, Beijing, Hong Kong and New York, and
presence in Boston, San Diego, San Francisco, and Tokyo. CBC
focuses on platform-building, buyout, credit and growth-focused
opportunities across multiple core areas within the healthcare
sector, including pharmaceutical and biotech, medical technology
and healthcare services. For more information, please visit
www.cbridgecap.com.
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 lead
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 it 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 and Japan; estimates of the number of patients impacted by
PFIC; expectations about Bylvay’s acceptance by healthcare
practitioners to treat PFIC patients; 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 once we have launched the product 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.com Lauren
Sneider,
857-300-1737, lauren.sneider@albireopharma.com
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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