CBC-backed Jadeite Medicines Announces Exclusive Licensing Agreement with Albireo Pharma to Develop and Promote Odevixibat in Japan
PR92219
TOKYO, Oct. 12, 2021 /PRNewswire=KYODO JBN/ --
- Agreement to accelerate the development and commercialization of odevixibat
in Japan, a significant market for PFIC, Alagille syndrome and biliary atresia
- Bylvay™ (odevixibat) approved in U.S., EU and UK with global prescriptions
already generated
- CBC continues its momentum to address significant unmet medical needs in Asia
Jadeite Medicines Inc. ("Jadeite"), a biopharmaceutical company that is backed
by Singapore's CBC Group ("CBC") and committed to addressing critical unmet
medical needs for patients in Japan, today entered into an exclusive licensing
agreement with Albireo Pharma, Inc. (Nasdaq: ALBO) for the development and
commercialization of 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
US$15 million and will be eligible to receive up to US$120 million in milestone
payments, as well as double-digit royalties. Jadeite will be responsible for
clinical development, regulatory approval and commercialization of odevixibat
in Japan, where there is significant market opportunity. Jadeite is backed by
CBC( http://www.cbridgecap.com/ ), which partners with the world's top
entrepreneurs and scientists and leverages its unique "investor-operator"
approach to empower global leading healthcare companies to widen access to
affordable medical care, catalyze innovations and improve efficiency in
fulfilling unmet medical needs worldwide.
"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."
"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's 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, and we look forward to further collaboration
with Jadeite."
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 Alagille
syndrome, the BOLD Phase 3 study for patients with biliary atresia and the
ongoing PEDFIC 2 open-label trial for patients with PFIC.
"CBC remains steadfast in our commitment to widening access to medical care
globally, and Jadeite is our cornerstone in Japan. The partnership with Albireo
represents important progress toward that goal by expanding more treatment
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."
CBC, founded in 2014, is Asia's largest healthcare-dedicated investment firm,
with US$4.6 billion AUM. Its portfolio has gained momentum in recent years by
incubating cutting-edge biopharmaceutical companies in Asia and beyond. Jadeite
is the first company to be incubated by CBC in Japan, following the success of
its unique investor-operator approached in empowering Nasdaq-listed I-Mab
Biopharma and Hong Kong-listed Everest Medicines.
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 in the ASSERT Phase 3 study for
Alagille syndrome.
About Albireo
Albireo 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 of A2342 moving ahead 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.
About Jadeite
Jadeite 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 an extensive track record of high-quality clinical development and deep
expertise in regulatory affairs, CMC, business development and operations, both
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 www.jadeitemedicines.co.jp.
About CBC
CBC Group, Asia's largest healthcare-dedicated investment firm, is committed to
creating value and integrating global resources. Partnering with the world's
top entrepreneurs and scientists, 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. Founded in 2014, CBC has a leading team of investment,
industry and portfolio management professionals headquartered in Singapore with
offices in Shanghai, Beijing, Hong Kong and New York, and presences 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.
SOURCE CBC Group
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