Rare Daily Staff

Albireo Pharma said it entered into an exclusive licensing agreement with Jadeite Medicines for the development and commercialization of Bylvay in Japan for progressive familial intrahepatic cholestasis, Alagille syndrome, and biliary atresia for $15 million in an upfront payment and potential milestones of up to $120 million.

Under the terms of the agreement, Jadeite Medicines will be responsible for clinical development, regulatory approval, and commercialization of Bylvay in Japan. Albireo will receive double-digit royalties in addition to the upfront payment and potential milestones.

“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 CEO of Albireo. “The agreement allows for success of both companies, while strengthening Albireo’s financial position.”

Bylvay is the first drug approved in Europe for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC) and in the United States for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor, 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.

Photo: Ron Cooper, President and CEO of Albireo

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