Mallinckrodt buying Calif. firm; N.J. unit to work on key product

Mallinckrodt plc, the U.K. pharmaceutical company that recently opened a Specialty Brands facility in Bedminster, is acquiring California-based Ocera Therapeutics and its therapy for hepatic encephalopathy.

A Mallinckrodt spokesperson said the deal should mean work for the New Jersey unit, which will be involved in product development and a potential launch of OCR-002.

A subsidiary of Mallinckrodt, which has its U.S. headquarters in St. Louis, will pay about $42 million for Ocera, plus milestone payments potentially reaching $75 million, according to a news release. Ocera, a clinical-stage biopharmaceutical company, focuses on treatments for liver diseases and other so-called “orphan” ailments.

Hepatic encephalopathy is a neuropsychiatric condition tied to liver disease.

“Hepatic encephalopathy can be a debilitating condition, affecting brain function and, in some cases, resulting in coma or death,” Dr. Steven Romano, Mallinckrodt’s executive vice president and chief scientific officer, said in a prepared statement. “We look forward to bringing this much-needed treatment option to patients who suffer from this condition.”

OCR-002 failed to meet statistical significance in its primary endpoint during a phase 2 trial, but achieved secondary endpoints, leading Mallinckrodt to believe design elements may have led in part to the primary outcome, it said. It hopes to gain FDA approval and launch an intravenous formulation by 2022 and an oral formulation by 2024.

(READ MORE from ROI-NJ on Mallinckrodt’s Bedminster site.)

“We believe OCR-002 has the potential to significantly alter the treatment paradigm for patients suffering from this serious condition,” Mark Trudeau, Mallinckrodt’s CEO and president, said in a statement. “The addition of this highly-durable, unique developmental asset to our portfolio is an excellent example of Mallinckrodt’s strategic vision as a patient-centric, innovation-driven specialty pharmaceutical growth company focusing on severe and critical conditions.”

The company expects the Ocera deal to close in the fourth quarter, pending customary approvals and conditions.