Ipsen et Albireo today announced that it has entered into a definitive merger agreement under which Ipsen acquires Albireo, a leading innovator of bile acid modulators for the treatment of cholestatic liver disease in children and adults. The planned acquisition will therefore allow Ipsen to strengthen its portfolio of commercialized products and products in ‘R&D’ in Rare Diseases.
The lead drug in Albireo’s portfolio is Bylvay (odevixibat), a potent once-daily, non-systemic oral ileal bile acid transport inhibitor (IBATi). Bylvay was approved in 2021 in the United States for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PIHC), as well as in the European Union for the treatment of CIFP in patients aged three months and older at six months. Pruritus is one of the most important and problematic clinical manifestations of the disease, which often leads to a serious decrease in the quality of life of patients.
Bylvay benefits from orphan exclusivity for the approved indications for the treatment of CIFP in the United States and the European Union.
“We welcome the potential in the science assets and capabilities of the Albireo acquisition and believe this is a solid growth opportunity for Ipsen,” said David Loew, CEO of Ipsen. “Bylvay, which, in addition to being the first drug approved for the treatment of CIFP, has two other indications under investigation in rare liver conditions with high unmet need and will therefore strengthen our franchise. In addition, Bylvay and the new clinical bile and preclinical acid transport inhibitors from Albireo’s portfolio complement our portfolio in the treatment of liver disease.”
“An unwavering commitment to patients and science has always guided Albireo’s actions. It was this determination that drove us to develop Bylvay and gain its approval as the first drug dedicated to the treatment of CIFP,” said Ron Cooper, President and CEO of Albireo. “Our team’s talent has helped advance the first phase III studies for three different childhood liver diseases, as well as uncovering two promising new bile acid modulators into clinical stage. We are confident that Ipsen is well positioned to implement its capabilities commercial and global research and development efforts to help more patients with cholestatic liver disease gain access to these medicines and bring hope to families first.”
In addition to this primary indication, Albireo announced in December 2022 that several other regulatory approval applications have been submitted for Bylvay in the European Union and the United States for the treatment of Alagille syndrome (AGS). SAG is a rare genetic disorder that can affect multiple organ systems, including the liver, with sparse bile ducts preventing the flow of bile from the liver to the small intestine. The most disabling symptom of cholestasis in SAG is severe pruritus. In the phase III ASSERT study, treatment with Bylvay met its primary and secondary endpoints, was associated with statistically significant improvements in pruritus severity and reductions in serum bile acids (SBA) compared to placebo, and was well tolerated.
Additionally, Bylvay is in late stage development for biliary atresia (BVA). The drug is currently in a study, called BOLD. This is the first prospective double-blind Phase III clinical trial for the treatment of AVB, a rare liver disease in children that can lead to cirrhosis and liver failure and is the leading cause of liver transplantation in children. Orphan drug status has been granted in indications for the treatment of SAG and BVA in the United States and within the European Union.
As part of the transaction, Ipsen will also acquire clinical-stage asset A3907, a novel oral systemic inhibitor of the apical sodium-dependent bile acid transporter (ASBT) currently in development for adult cholestatic liver diseases, such as primary sclerosing cholangitis (PSC), which could complement Ipsen’s development programs. In addition to Bylvay and A3907, Albireo’s portfolio also includes the active A2342, an oral systemic inhibitor of sodium taurocholate cotransporter peptide (NTCP), under evaluation for viral and cholestatic diseases, which is progressing through studies aimed at to approve new drug trials.
Key financial data
The Albireo acquisition will immediately drive additional sales and strengthen Ipsen’s rare disease infrastructure. Albireo provided Bylvay’s $24 million sales forecast for full year 2022. ‘Ipsen through the end of 2024.
This is in line with Ipsen’s medium-term outlook regarding its strategic orientation to build a portfolio of high-value-added and sustainable ‘R&D’ products through external innovation. The group will present its annual goals for 2023 in February.
Transaction Details
Under the terms of the agreement and the proposed merger, Ipsen, through a wholly owned subsidiary, will launch a tender offer to acquire all outstanding shares of Albireo at a price of $42 per share in cash at closing of the transaction, for a total initial amount estimated at $952 million, plus a Guaranteed Value Certificate (CVG) per share. Each CVG will entitle its holder to a deferred cash payment of $10.00 per CVG, available subject to Bylvay’s U.S. Regulatory Authority (FDA) approval in the indication of biliary atresia on or before December 31, 2027 , allowing for a potential increase in patient numbers in the BOLD study.
The price of $42 per share represents a 104% premium over Albireo’s one-month volume weighted average price of $20.60 prior to the announcement of the transaction. The transaction will be financed entirely from Ipsen’s existing cash and credit lines. The members of Albireo’s board of directors unanimously approved the transaction and recommended that Albireo’s shareholders bring their shares to the tender offer.
The closing of the tender offer will be subject to the customary conditions, in particular the contribution of shares representing at least the majority of the total number of shares outstanding of Albireo, as well as compliance with the waiting period foreseen in the Hart-Scott – Rodino Antitrust Improvements agreement Act and obtain clearances from any governmental agency or under certain foreign antitrust laws and the expiration of any applicable waiting periods and other customary conditions. If the tender offer is successful, Ipsen would acquire all shares not acquired in the tender offer through a second merger transaction for the same amount that the depositor shareholders will receive under the tender offer. The transaction is expected to close by the end of the first quarter of 2023.
