Mallinckrodt To Acquire Ocera TherapeuticsBy
Mallinckrodt, a specialty pharmaceutical company, has agreed to acquire Ocera Therapeutics, a Redwood City, California-headquartered clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, for $117 million.
Ocera’s developmental product, OCR-002, an ammonia scavenger, is being studied for treating hepatic encephalopathy, a neuropsychiatric syndrome associated with hyperammonemia, a complication of acute or chronic liver disease.
OCR-002 is a Phase II drug with both intravenous (IV) and oral formulations. Mallinckrodt plans to have continued engagement with the US 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.
The FDA granted OCR-002 orphan-drug designation, and the resulting seven years’ exclusivity would be applied upon first approval of the drug. The FDA also granted fast-track designation, a process designed to facilitate development and expedite the review of drugs. The European Medicines Agency also granted orphan drug status to OCR-002.
Subject to customary closing conditions, the company estimates the transaction will close in the fourth quarter of 2017.