Ipsen Expands Rare Disease Franchise with Acquisition of Albireo

Ipsen entered into a definitive agreement to acquire Albireo, a developer of bile-acid modulators to treat pediatric and adult rare liver diseases, a move designed to expand its portfolio and pipeline of rare disease therapies, for $952 million and up to $227 million in contingent value rights.

Photo: David Loew, CEO of Ipsen

Under the terms of the agreement, Ipsen, through a fully-owned subsidiary, will initiate a tender offer to acquire all outstanding shares of Albireo at a price of $42.00 per share in cash at the closing of the transaction plus one contingent value right (CVR) per share. Each CVR will entitle its holder to deferred cash payments of $10.00 per CVR payable upon the U.S. Food and Drug Administration approval of Bylvay in the biliary atresia indication at the latest by 31 December 2027, allowing for a potential increase in the number of patients in the BOLD study.

The $42.00 per-share cash consideration represents a premium of 104 percent compared to Albireo’s 1-month volume-weighted average price of $20.60 preceding announcement of the transaction. The transaction will be fully financed by Ipsen’s existing cash and lines of credit. The board of Albireo has unanimously approved the transaction and recommended that the stockholders of Albireo tender their shares in the tender offer.

The closing of the tender offer will be subject to customary conditions. Upon the successful completion of the tender offer, Ipsen would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close by end of Q1, 2023.

The acquisition of Albireo will provide immediate incremental sales and strengthen Ipsen’s rare disease infrastructure. Albireo guided for total Bylvay revenues of $24 million for 2022. Given the level of ongoing R&D expenses, the transaction is expected to be dilutive to Ipsen’s core operating income until the end of 2024. The company is expected to provide guidance for 2023 in February.

Albireo’s Bylvay is a once-daily, oral, non-systemic ileal bile acid transport inhibitor (IBATi). The FDA approved Bylvay in 2021 the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC), and in the European Union for the treatment of PFIC in patients aged six months or older. Pruritus is one of the most prominent and problematic manifestations of the disease, often resulting in severely diminished quality of life. Bylvay has orphan exclusivity for the approved indications in PFIC in the United States and European Union.

In addition to this lead indication, Albireo announced in December 2022 that supplementary regulatory filings have been made for Bylvay in the EU and the U.S. for Alagille syndrome (ALGS). ALGS is a rare, genetic disorder that can affect multiple organ systems, including the liver, with a paucity of bile ducts preventing bile flow from the liver to the small intestine. The most debilitating symptom of ALGS is severe pruritus. In the phase 3 ASSERT trial, treatment with Bylvay met both primary and secondary endpoints and was associated with statistically significant improvements in pruritus severity and reductions in serum bile acid levels compared to placebo, and was well tolerated.

Bylvay is also in late-stage development for biliary atresia (BA). It is currently being investigated in the BOLD study, the first, prospective double-blind, phase 3 clinical trial in BA, a rare, pediatric liver disease that can result in cirrhosis and liver failure and is the leading cause of liver transplantation among children. Orphan drug designations have been granted in both ALGS and BA indications in the United States and European Union.

“We believe this is a compelling growth opportunity for Ipsen.” said David Loew, CEO of 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.”