In its fourth-quarter earnings presentation on Thursday, Ipsen disclosed that it recorded a partial impairment charge of €669 million ($726 million) stemming from a pair of recent disappointments in its palovarotene programme for fibrodysplasia ossificans progressiva (FOP). CEO Aymeric Le Chatelier said that "despite the palovarotene setback, the fundamentals of our business remain strong," adding that Ipsen has also updated its 2022 outlook "taking into account the latest developments in the current business."
Late last year, the FDA placed a partial clinical hold affecting patients under 14 years of age enrolled in studies of palovarotene for the chronic treatment of FOP and multiple osteochondroma amid safety concerns. Meanwhile, in January, Ipsen said a futility analysis indicated that the Phase III MOVE study, also known as PVO-1A-301, testing palovarotene in patients with FOP was unlikely to meet its primary endpoint. The company noted at the time that it would pause dosing in FOP trials as it considers an independent Data Monitoring Committee recommendation "not to discontinue" the study as "encouraging therapeutic activity [was] observed in preliminary post-hoc analyses."
On Thursday, Ipsen stated that it will "continue the development of palovarotene, conduct further assessment of the MOVE dataset, address the FDA questions and define next steps for the clinical programme." The drugmaker gained the RAR gamma agonist via its purchase of Clementia Pharmaceuticals in 2019 for a cash payment of around $1 billion upfront.
Ipsen said its updated 2022 outlook, which assumes no contribution from palovarotene, nor any additional meaningful products or indications, anticipates net sales greater than €2.8 billion ($3 billion). It noted that the forecast assumes the progressive entry of additional octreotide and lanreotide generics globally from 2021. In October, the company said it was expecting to file palovarotene for FDA approval for the episodic treatment of FOP in the first quarter of this year.
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