FRANCE — Ipsen and Albireo have agreed to merge, with Ipsen acquiring Albireo, a rare disease company focused on the development of bile acid modulators for the treatment of pediatric and adult liver diseases.

The anticipated acquisition will enrich Ipsen’s Rare Disease portfolio and pipeline.

Bylvay, Albireo’s lead product, was approved by the FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis, and it is also approved in Europe for the treatment of progressive familial intrahepatic cholestasis (PFIC).

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.

Albireo was spun out of AstraZeneca in 2008 and is based in Boston, Massachusetts, with a subsidiary in Gothenburg, Sweden.

Ipsen will launch a tender offer to acquire all outstanding shares of Albireo for US$42.00 per share in cash, for an initial estimated aggregate consideration of US$952 million plus one contingent value right (CVR) per share, through a subsidiary.

Each CVR entitles the holder to US$10.00 in deferred cash payments if Bylvay is approved by the FDA in the Biliary Atresia indication by December 31, 2027. Albireo’s Board of Directors has approved the transaction.

Ipsen will also acquire Albireo’s clinical stage asset A3907, which is an oral systemic apical sodium-dependent bile acid transporter inhibitor in development for adult cholestatic liver disease.

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.

Ipsen said the acquisition of Albireo will provide immediate incremental sales and strengthen the company’s rare disease infrastructure. It is anticipated the transaction will close by end of Q1, 2023.

The company expects the acquisition to be dilutive to core operating income until the end of 2024. This is in line with Ipsen’s medium-term outlook regarding its strategic focus on building a high-value and sustainable pipeline through external innovation.

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