Rare Daily Staff

Ipsen has agreed to pay up to $1.3 billion to acquire Clementia Pharmaceuticals, which is in late-stage development of an experimental therapy for ultra-rare and debilitating bone disorders.

Clementia is developing palovarotene, an experimental treatment for fibrodysplasia ossificans progressive (FOP), multiple osteochondromas (MO), and other diseases. Palovarotene inhibits excess bone morphogenetic protein signaling, which is linked to the progression of FOP and MO. There are currently no treatment options available for those conditions.

“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, CEO of 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.”

Under the terms of the agreement, Ipsen will pay $25.00 per share in cash 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 of $6 per share upon U.S. Food and Drug Administration acceptance of the company’s application to market palovarotene for the treatment of MO, representing an additional potential payment of $263 million. The initial cash consideration represents a premium of 77 percent to Clementia’s 30-day volume-weighted average stock price.

The company expects to submit an application for marketing approval to the FDA for palovarotene for episodic flare-up treatment of FOP in the second half of 2019, and subject to FDA approval, a first commercial launch is expected in mid-2020.

A phase 3 registrational trial evaluating a chronic dosing regimen for FOP, a phase 2 trial for MO, and a phase 1 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 (EMA), and Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations for FOP from the FDA.

“Ipsen’s global commercial presence and capabilities will expedite our shared vision of bringing palovarotene to patients around the world as quickly as possible,” said Clarissa Desjardins, CEO of Clementia. “We anticipate a smooth transition of our operations into the Ipsen organization that will continue Clementia’s vision of delivering palovarotene to patients worldwide.”

The transaction will be fully financed by Ipsen’s existing cash and lines of credit and significantly increases the level of net debt. 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.

Photo: Clarissa Desjardins, CEO of Clementia