Ipsen Completes Acquisition of Clementia Pharmaceuticals
Ipsen and Clementia Pharmaceuticals announced the closing of Ipsen’s acquisition of Clementia following approval of the arrangement by Clementia shareholders and the Quebec Superior Court. Pursuant to the arrangement, Clementia shareholders will receive US$25.00 per share in cash upfront and one contingent value right (CVR) per share entitling them to receive US$6.00 per CVR upon the U.S. Food and Drug Administration’s (FDA) acceptance of the regulatory filing for palovarotene for the treatment of multiple osteochondromas (MO).
Clementia’s key late-stage clinical asset palovarotene is an investigational retinoic acid receptor gamma (RARγ) selective agonist, for the treatment of two rare bone disorders, fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO), and other diseases.
The palovarotene regulatory submission for the prevention of heterotopic ossification (HO) in patients with FOP in the U.S. is expected for the second half of 2019. The submission will be based on Phase 2 clinical data from greater than 100 imaged flare-ups and indicated that treatment with palovarotene resulted in a greater than 70% reduction of new heterotopic ossification (HO), or bone formation, across all three dosing levels.
Dr. Alexandre Lebeaut, Chief Scientific Officer of Ipsen, commented, “We are encouraged by compelling and consistent clinical data from the extensive Phase 2 program as well as fast-track, breakthrough therapy, orphan drug and rare pediatric diseases designations from the FDA. We are focused on the successful regulatory submission of palovarotene as a first-in-class therapeutic solution for patients with episodic flare-up treatment of fibrodysplasia ossificans progressiva in the second half of 2019.”
Dr. Clarissa Desjardins, Chief Executive Officer of Clementia, added, “I am extremely grateful for the hard-working and dedicated team at Clementia, the patient community and the clinical trial investigators who have helped advance the palovarotene program. Going forward, we are confident that Ipsen, with its shared patient-centric culture, proven development capabilities and global commercial footprint, will fulfill our ambition of delivering palovarotene to patients worldwide as quickly as possible.”