Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back — this time flunk­ing fu­til­i­ty test — as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a bil­lion dol­lars in cash to buy Clemen­tia and a late-stage pro­gram for a rare bone dis­ease that af­flicts chil­dren, then CEO David Meek was con­fi­dent that he had put the French biotech on a short path to a mid-2020 launch.

In­stead of prep­ping a launch, though, the com­pa­ny was hit with a hold on the FDA’s con­cerns that a ther­a­py de­signed to pre­vent over­growth of bone for cas­es of fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va might ac­tu­al­ly stunt chil­dren’s growth. So they or­dered a halt to any treat­ments for kids 14 and un­der. Meek left soon af­ter to run a start­up in Boston. And to­day the Paris-based biotech is grap­pling with the in­de­pen­dent mon­i­tor­ing com­mit­tee’s de­ci­sion that their Phase III had failed a fu­til­i­ty test.

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