The acquisition will see Ipsen buyout ClementiaPharmaceuticals and its late-stage clinical asset palovarotene, an investigational retinoic acid receptor gamma selective agonist.
Under the terms of the agreement, Ipsen will pay $1.04bn (€98m) upfront on completion of the transaction, paying $25 per share. An additional payment of $236m is contingent upon further regulatory milestones.
The transaction will be financed by Ipsen’s existing cash and lines of credit. The company said in a statement that, factoring in the deal, it expects sales growth of 13% and a core operating margin of 30% net sales in.
A spokesperson for Ipsen told us that this transaction, its largest to date, also leverages its track record of commercializing specialized diseases across therapy areas.
David Meek, CEO, Ipsen said in a statement, “Through this transaction, we will gain scientific expertise, exceptional talent, and a cornerstone ultra-rare disease drug candidate with rare pediatric disease and breakthrough therapy designations, potential US approval in 2020 and additional indications to follow.”
A new drug application (NDA) for palovarotene is expected to be submitted to the US Food and Drug Administration (FDA) in the second half of 2019 and, subject to approval, commercial launch is expected in mid-2020.
Palovarotene inhibits excess bone morphogenetic protein (BMP) signaling, which is linked to the development of fibrodysplasia ossificiansprogressive (FOP) and multiple osteochondromas (MO). Both FOP and MO are ultra-rare or rare and severely disabling bone disorders, with nocurrent treatment options.
The drug candidate has received an orphan drug designation for FOP and MO from the FDA and European Medicines Agency (EMA).