JADEITE MEDICINES

Tokyo, Japan – January 31, 2024 – Jadeite Medicines Inc. (Jadeite Medicines), a clinical-stage biopharmaceutical company headquartered in Tokyo, Japan, today announced a definitive agreement with Albireo Pharma Inc, a wholly-owned subsidiary of Ipsen (Euronext: IPN: ADR: IPSEY), for the development and commercialization in Japan of odevixibat, a potent, non-systemic iBAT inhibitor being developed and commercialized by Ipsen in the U.S. and Europe. Both companies initially entered into an exclusive licensing agreement on October 12th 2021, for the development and commercialization of odevixibat in Japan.

Under the terms of this new agreement, Jadeite Medicines will receive an upfront payment and is eligible to receive milestone payments based upon the achievement of specified regulatory milestones. Ipsen will be responsible for commercialization and has an exclusive option to reacquire the Japanese rights to odevixibat. By entering this strategic collaboration with Ipsen, Jadeite Medicines aims to accelerate the availability and accessibility of odevixibat to Japanese patients.

Jadeite Medicines received Orphan Drug Designation for odevixibat in Progressive Familial Intrahepatic Cholestasis (PFIC) from the Ministry of Health, Labour and Welfare of Japan in May 2023, followed by the initiation of the Phase III trial in PFIC for patients in Japan. PFIC is a spectrum of autosomal recessive genetic disorders in which cholestasis may lead to end-stage liver disease, affecting young children with no approved treatment in Japan.

Commenting on the transaction, Eiichi Takahashi, President, and Chief Executive Officer of Jadeite Medicines, stated, “This strategic collaboration with Ipsen is a pivotal milestone for Jadeite Medicines. We believe that Ipsen’s strong expertise in rare liver diseases will significantly contribute to the successful commercialization of odevixibat. This partnership underscores our dedication to bringing innovative therapies to address critical unmet medical needs in Japan.”

About Bylvay® (odevixibat)
Bylvay (odevixibat) is a potent, non-systemic ileal bile-acid transport inhibitor (IBATi). It is approved in the U.S. for the treatment of pruritus in patients three months of age and older with PFIC, and for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille Syndrome (ALGS). Bylvay was launched in the U.S. in 2021, where it is supported by a program designed to assist with access to treatment and patient support. Bylvay is also approved in the E.U. for the treatment of PFIC in patients aged six months or older. It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, the U.K., France and Belgium. In a third indication, the rare paediatric cholestatic liver disease, biliary atresia, Bylvay is in late-stage development with the Phase III BOLD trial.

About Jadeite Medicines Inc.
Jadeite Medicines Inc. is a biopharmaceutical company established in 2020 to address the unmet medical needs of patients in Japan by introducing and developing innovative medicines from around the world. Jadeite Medicines team consists of highly experienced professionals in the field of clinical development, regulatory, CMC and business development. For more information, visit jadeitemedicines.co.jp.

About Ipsen
Ipsen is a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Ipsen’s pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Ipsen’s teams in more than 40 countries and our partnerships around the world enable Ipsen to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.