Ipsen and Clementia Pharmaceuticals have entered into an agreement for Ipsen to acquire Clementia for $1.31 billion. The purchase includes Clementia’s key late-stage clinical asset palovarotene, an investigational retinoic acid receptor gamma (RARγ) selective agonist, for the treatment of fibrodysplasia ossificans progressiva (FOP), multiple osteochondromas (MO) and other diseases.
 
A New Drug Application (NDA) for palovarotene for episodic flare-up treatment of FOP is expected to be submitted to the U.S. FDA in the second half of 2019, and subject to FDA approval, a first commercial launch is expected in mid-2020.
 
“The acquisition of Clementia Pharmaceuticals accelerates the ongoing transformation of Ipsen as we are successfully executing on our external innovation strategy to identify and acquire innovative medicines to serve patients with unmet medical needs,” said David Meek, chief executive officer, Ipsen. “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 U.S. approval in 2020 and additional indications to follow.”
 
Clarissa Desjardins, chief executive officer, Clementia, said, “I am proud of the entire Clementia team, whose tireless efforts have rapidly advanced palovarotene towards a planned NDA submission, and we are all grateful for the dedication of the patient community and our clinical trial investigators who have supported us along the way. Ipsen’s global commercial presence and capabilities will expedite our shared vision of bringing palovarotene to patients around the world as quickly as possible. We anticipate a smooth transition of our operations into the Ipsen organization that will continue Clementia’s vision of delivering palovarotene to patients worldwide.”