Mallinckrodt has signed an agreement to acquire US-based Ocera Therapeutics, a clinical-stage biopharmaceutical company in a deal valued at approximately $117m.

Ocera’s developmental product, known as OCR-002, is an ammonia scavenger currently being studied to treat hepatic encephalopathy, a neuropsychiatric syndrome that is associated with hyperammonemia, a complication of acute or chronic liver disease.

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The Phase II asset has both intravenous (IV) and oral formulations.

Ocera Therapeutics president and CEO Linda Grais said: “We believe OCR-002 has the potential to help thousands of patients whose hepatic encephalopathy is insufficiently treated by current therapies.

“We’re excited by the additional development capability and commercial reach that can be gained by becoming part of Mallinckrodt. With this focus, I’m confident this important treatment can be successfully brought to market.”

“We believe OCR-002 has the potential to significantly alter the treatment paradigm for patients suffering from this serious condition.”

Treatment with OCR-002 rapidly eliminates ammonia in the bloodstream, excreting it through the kidneys. Its active ingredients are ornithine and phenylacetic acid (PAA).

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Hepatic encephalopathy (HE) is a critical neuropsychiatric condition resulting from hyperammonemia. While many patients who develop this condition will have cirrhosis, its incidents are also reported in patients with other types of liver disease such as acute liver failure or bypass shunts.

Mallinckrodt President and CEO Mark Trudeau said: “We believe OCR-002 has the potential to significantly alter the treatment paradigm for patients suffering from this serious condition.

“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.”

Ocera holds worldwide rights to OCR-002, and Mallinckrodt estimates the market for HE patients in Europe and Japan to be in the range of 150,000 to 200,000 a year.