ImmuCell Corp., a growing animal health company that is developing, manufacturing and selling products that improve animal health and productivity in the dairy and beef industries, announced Dec. 22 that it has entered into a product development and contract manufacture agreement with Northern Ireland-based Norbrook Laboratories Ltd., a global player in the development of veterinary and animal health medicines. The new agreement covers the final formulation and sterile-filling services for ImmuCell's nisin-based Mast Out product.

Since 2010, ImmuCell has been party to an exclusive contract manufacture agreement with Norbrook, an Food & Drug Administration-approved drug product (filled and packaged syringes) manufacturer, covering the formulating and sterile-filling of syringes for Mast Out. Norbrook provided these services for clinical material used in all pivotal studies of the product. This revised agreement with Norbrook covers the final development tasks and commercial-scale (but not at small-scale) launch of Mast Out after FDA approval. This means ImmuCell will not seek FDA approval at small-scale, which would not have provided inventory for significant commercial sales.

ImmuCell president and chief executive officer Michael F. Brigham said, "This agreement allows us to focus our efforts and investments on the production of nisin and leave the sterile-filling of syringes to this world-class expert. That plays to our strengths and the strengths of Norbrook to increase the probability of achieving a regulatory and commercial success together.

"We continue to execute on the two core components of our business strategy," Brigham added. "First, we are expanding the market penetration of First Defense, our best-in-class treatment for calf scours. The addition of a bovine rotavirus disease claim to our existing claims against Escherichia coli and coronavirus infections could allow us to bring the first passive antibody product with this breadth of disease claims to market in 2016. Second, we are advancing the development of Mast Out, our novel treatment for subclinical mastitis in lactating dairy cows. Our ground-breaking product innovation is unlike all other mastitis treatments on the market today that are all sold subject to a milk discard period. Our goal is to revolutionize the way mastitis is treated by making earlier treatment of subclinical infections economically feasible by not requiring a milk discard or meat withhold during, or for a period of time after, treatment. No other product presently on the market can offer this value proposition.”

ImmuCell's purpose is to create scientifically-proven and practical products that improve animal health and productivity in the dairy and beef industries.