ImmuCell Corp., a Portland-based biotechnology company, has signed a new manufacturing agreement with an Irish firm in its pursuit to secure federal regulatory approval for a animal-health product its developing for the dairy industry.

The company, founded in 1982, has spent the last decade developing a product called Mast Out, which treats mastitis in lactating dairy cows. The product is unique because it provides early treatment of the infection without requiring dairy farmers to throw out milk, according to ImmuCell CEO Michael Brigham.

ImmuCell has developed a timeline for U.S. Food and Drug Administration approval for Mast Out in late 2018 or early 2019, though there are “many risks and variables” along that path that could change the timeline, Brigham said.

As part of the path to regulatory approval, ImmuCell has worked since 2010 with a company called Norbrook Laboratories Ltd. of Newry, Northern Ireland, which has performed the highly technical task of sterile-filling the Mast Out material into the delivery tubes used in clinical trials, Brigham said. ImmuCell has now signed a revised agreement with Norbrook that will see the Irish company producing Mast Out for commercial application, pending FDA approval.

“This agreement allows us to focus our efforts and investments on the production of Nisin (the active ingredient in Mast Out) and leave the sterile-filling of syringes to this world-class expert,” Brigham said. “That plays to our strengths and the strengths of Norbrook to increase the probability of achieving a regulatory and commercial success together.”

ImmuCell had 38 employees as of Nov. 12, according to its third-quarter financial report filed with the U.S. Securities and Exchange Commission. Its net operating income during the third quarter, which ended Sept. 30, was $627,000, a 1,429 percent increase from its net operating income of $41,000 during the same quarter last year.

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