Ipsen To Acquire Clementia for $1.3 Billion
Ipsen, a pharmaceutical company headquartered in Paris, and Clementia Pharmaceuticals, a biopharmaceutical company headquartered in Montreal, have entered into an agreement for Ipsen to acquire Clementia for approximately $1.31 billion. The move adds to Ipsen’s rare-disease portfolio by leveraging Clementia’s expertise and Ipsen’s global commercial footprint.
The acquisition includes Clementia’s late-stage drug candidate, palovarotene, which has rare pediatric disease and breakthrough therapy designations for the treatment of an ultra-rare bone disorder and a path to approval in 2020.
Under the terms of the agreement, Ipsen will pay $25.00 per share in cash upfront on completion of the transaction, for an initial aggregate consideration of $1.04 billion, plus deferred payments on the achievement of a future regulatory milestone in the form of a contingent value right (CVR) of $6.00 per share upon FDA acceptance of the new drug application filing for palovarotene for the treatment of multiple osteochondromas (MO), representing an additional potential payment of $263 million.
The Boards of Directors of both companies have approved the transaction. Completion of the transaction is anticipated to occur in the second quarter of 2019, subject to satisfaction of all closing conditions. The acquisition will proceed by way of a court-approved plan of arrangement pursuant to the Canada Business Corporations Act and will require, at a special meeting of Clementia shareholders expected to be held on or about April 9, 2019, the approval of at least 66.66% of the votes cast by Clementia’s shareholders.
Palovarotene is an investigational retinoic acid receptor gamma (RARγ) selective agonist for the treatment of fibrodysplasia ossificans progressiva (FOP), multiple osteochondromas (MO), and other diseases. Palovarotene inhibits excess bone morphogenetic protein (BMP) signaling, which is linked to the progression of FOP and MO, two well-characterized, ultra-rare/rare and severely-disabling bone disorders, according to information from the companies. Palovarotene was in-licensed from Roche Pharmaceuticals.
The companies say that a new drug application (NDA) for palovarotene for episodic flare-up treatment of FOP is expected to be submitted to the US Food and Drug Administration (FDA) in the second half of 2019, and subject to FDA approval, a first commercial launch is expected in mid-2020. A Phase III registrational trial evaluating a chronic dosing regimen for FOP, a Phase II trial for MO, and a Phase I trial for dry-eye disease are also ongoing. Palovarotene has received orphan-drug designation for FOP and MO from the FDA and the European Medicines Agency and fast-track, breakthrough-therapy and rare pediatric disease designations for FOP from the FDA.
