Albireo Pharma (ALBO) Announces Exclusive Licensing Agreement with Jadeite Medicines for Bylvay in Japan

October 12, 2021 8:32 AM EDT
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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 (, 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.”

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