Mallinckrodt and Ocera Therapeutics have entered into an agreement under which Mallinckrodt will acquire Ocera, a clinical stage biopharmaceutical company focused on the development and commercialisation of novel therapeutics for orphan and other serious liver diseases with high unmet medical need.
Ocera’s developmental product OCR-002, an ammonia scavenger, is being studied for treatment of hepatic encephalopathy, a neuropsychiatric syndrome associated with hyperammonemia, a complication of acute or chronic liver disease. OCR-002 is a Phase 2 asset with both intravenous (IV) and oral formulations.
Despite inability to meet statistical significance in its primary endpoint, Ocera’s Phase 2 STOP-HE trial achieved secondary endpoints that revealed differentiated clinical impact, including demonstrated effect on lowering serum ammonia levels. On acquisition, Mallinckrodt will invest to establish the optimal dosing regimen prior to initiating a Phase 3 program.
Mallinckrodt will have continued engagement with the U.S. Food and Drug Administration (FDA) to confirm the regulatory pathway to gain FDA approval and subsequently launch the IV formulation, expected by 2022, and the oral formulation, expected by 2024.
Dr Steven Romano, Chief Scientific Officer and Executive Vice President of Mallinckrodt, said: “We look forward to bringing this much-needed treatment option to patients who suffer from this condition.”
Dr Linda S. Grais, President and Chief Executive Officer, Ocera, said: “We’re excited by the additional development capability and commercial reach that can be gained by becoming part of Mallinckrodt.”