ImmuCell mastitis treatment comes one step closer to 2020 launch

ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle, today announced an important milestone in the development of its purified Nisin product.

ImmuCell learned today that the FDA has issued a Technical Section Complete Letter for the Human Food Safety Technical Section of ImmuCell’s New Animal Drug Application (“NADA”) for its Nisin-based intramammary treatment of subclinical mastitis in lactating dairy cows. There are five major Technical Sections to a NADA with the FDA. ImmuCell previously received three of the five Technical Section Complete Letters required for NADA approval. This fourth Complete Letter leaves just the manufacturing technical section (known as the Chemistry, Manufacturing and Controls (“CMC”) Technical Section) remaining for product approval and market launch.

“This milestone confirms the previously announced zero milk discard and zero meat withhold claims for our Nisin product in the US,” commented Michael F. Brigham, President and CEO. “Subject to final NADA approval by the FDA, we seek to bring this novel mastitis treatment to market in 2020.”

“This approval is the result of the FDA’s review of many years of studies addressing the important food safety issues of antimicrobial resistance, effects of residues on human intestinal flora, toxicology and residue chemistry,” added Joseph H. Crabb, Vice President and CSO. “It is rewarding to achieve zero withdrawal status supporting our objective to bring a product to market that poses minimal risks to public health from antimicrobial resistant organisms originating from Nisin-treated cattle.”

A first submission of the CMC Technical Section is anticipated in the coming weeks. At least two sequential submissions (the first covering the Drug Substance and the second covering the Drug Product) will be required. Each submission is subject to a six-month review period by the FDA.

Cautionary Statement Regarding Forward-looking Statements (Safe Harbor Statement):

Source: AP Newswire
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