Ipsen has completed the acquisition of Albireo Pharma, an innovator in bile-acid modulators to treat rare liver conditions.
The acquisition enriches Ipsen’s Rare Disease portfolio, with promising therapeutics for pediatric and adult rare cholestatic-liver diseases, innovative pipeline potential, as well as scientific and commercial capabilities.
Pursuant to the transaction, Ipsen acquires all the issued and outstanding shares at a price of $42.00 per share in cash (for an initial estimated aggregate consideration of $952 million) plus one non-transferable contingent value right (CVR) of $10.00 per share.
“The acquisition of Albireo will greatly strengthen our portfolio in rare diseases,” said David Loew, Chief Executive Officer of Ipsen. “I am excited to welcome new colleagues to Ipsen, who led the innovation on the development of novel bile acid modulators, like Bylvay, to treat rare liver diseases in children and adults. With Ipsen’s global presence, together we will be able to bring the full potential of the approved medicines to patients around the world.”
Lead medicine, Bylvay, is a potent once-daily ileal bile acid transport inhibitor (IBATi) that received regulatory approvals in 2021 in the U.S. for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC) and in the E.U. for the treatment of PFIC in patients aged six months or older.
In addition to the lead indication, Bylvay was accepted for Priority Review by the U.S. FDA for pediatric and adult Alagille syndrome (ALGS) in February 2023 with a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023. A variation seeking authorization for ALGS was also submitted to the EMA in 2022, which has been validated for review.
In a third indication, the rare pediatric cholestatic liver disease, biliary atresia (BA), Bylvay is in late-stage development with the Phase III BOLD (Biliary atresia and the use of Odevixibat in treating Liver Disease) trial. This is the first, prospective, double-blind clinical trial in this patient population. Bylvay has orphan exclusivity for the approved indications in PFIC in the U.S. and E.U., and orphan drug designations have been granted in both ALGS and BA indications in the U.S. and E.U.
As part of the transaction, Ipsen has also acquired A3907 and A2342, two clinical-stage assets in Albireo’s pipeline. A3907 is a novel oral systemic apical sodium-dependent bile-acid transporter inhibitor currently in Phase II clinical development for primary sclerosing cholangitis (PSC). A2342 is an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor being evaluated for viral and cholestatic diseases in a Phase I trial.