Ipsen and Albireo declared today that they have signed a binding merger agreement under which Ipsen would buy Albireo, a pioneer in the development of bile-acid modulators for the treatment of cholestatic liver disorders in both children and adults. The upcoming acquisition will improve Ipsen’s pipeline and portfolio for rare diseases.
Bylvay® (odevixibat), a powerful, once-daily, oral, non-systemic ileal bile acid transport inhibitor, is the main drug in Albireo’s pipeline (IBATi). In the U.S. and the E.U., Bylvay was approved in 2021 for the treatment of pruritus in individuals with progressive familial intrahepatic cholestasis (PFIC) who are three months of age or older, as well as for the treatment of PFIC in patients who are six months of age or older. One of the most noticeable and troubling symptoms of the illness, pruritus frequently has a profoundly negative impact on quality of life. In the U.S. and the E.U., Bylvay has orphan exclusivity for the PFIC approved indications.
“We are excited about the potential of Albireo’s assets and scientific expertise, which we gain through this acquisition, and we believe this is a compelling growth opportunity for Ipsen.” “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved. Additionally, Bylvay and the clinical and preclinical novel bile acid transport inhibitors in Albireo’s portfolio complement our own pipeline in liver disease.”
David Loew, Chief Executive Officer of Ipsen
“Unwavering dedication to patients and commitment to science have always been the north star for Albireo. This focus has driven us to develop and gain approval for Bylvay as the first drug treatment for PFIC”, “Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators. We believe that Ipsen is well positioned to apply its global R&D and commercial capabilities to make these medicines available to more cholestatic liver disease patients and accelerate the mission of providing hope for families. ”
Ron Cooper, President and Chief Executive Officer of Albireo
Albireo stated in December 2022 that additional regulatory files had been submitted for Bylvay in the E.U. and the U.S. for Alagille syndrome in addition to this primary indication (ALGS). Due to a lack of bile ducts, ALGS is a rare genetic illness that can affect several organ systems, including the liver. Bile flow from the liver to the small intestine is thus prevented. Severe itching and pruritis are ALGS’s most distressing symptoms. Bylvay therapy was well tolerated and met both primary and secondary objectives in the Phase III ASSERT trial. It was also related with statistically significant reductions in blood bile acid levels and improvements in pruritus severity when compared to placebo.
Furthermore, Bylvay, a treatment for biliary atresia, is in late-stage development (BA). The BOLD research, the first prospective double-blind Phase III clinical trial in BA, a rare juvenile liver disease that can develop cirrhosis and liver failure and is the most common reason for liver transplantation in children, is currently looking into it. Both ALGS and BA indications have received orphan drug designations from the US and EU.
A3907, a novel oral systemic sodium-dependent bile acid transporter (ASBT) inhibitor being developed for adult cholestatic liver diseases like primary sclerosing cholangitis (PSC), will also be acquired by Ipsen as part of the transaction. This asset could complement Ipsen’s current development programes. Along with Bylvay and A3907, Albireo’s pipeline also consists of A2342, an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor that is advancing in IND-enabling trials and is being tested for viral and cholestatic disorders.