ImmuCell Corp. announced that it has received a response from the U.S. Food & Drug Administration to its first phased nisin drug substance submission of the Chemistry, Manufacturing & Controls (CMC) technical section for Re-Tain, the company’s novel treatment in development for subclinical mastitis in lactating dairy cows.
According to the announcement, under FDA’s phased submission process, Phase 1 concerns the nisin drug substance and Phase 2 concerns the Re-Tain drug product (formulated nisin filled in a syringe). As part of the phased submission process, FDA issued a "technical section incomplete letter" with various requests and queries in addition to referring to the fact that the second phased submission has yet to be submitted.
ImmuCell explained that this process allows a sponsor to respond to identified deficiencies from the first phased submission at the time of the second phased submission. The company said it expects to submit the second phased drug substance and drug product CMC technical section around the third quarter of 2020.
In addition to responding to comments raised by the FDA regarding the first phased submission, one of the key components of the second phased submission is demonstrating stability of the product over time using the commercial process and the commercial syringe, the company added.
“Having reviewed the comments from FDA, we see no road blocks on our path to FDA approval for Re-Tain,” ImmuCell president and chief executive officer Michael F. Brigham said. “We believe we can respond effectively to FDA’s comments without significant additional cost or time delays.”
Having previously achieved four different "technical section complete letters" from FDA, approval of the CMC technical section is the fifth and final significant step required before product sales can be initiated in the U.S., ImmuCell said.
ImmuCell's purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell markets First Defense, providing Immediate Immunity to newborn dairy and beef livestock, and is in the late stages of developing Re-Tain, a novel treatment for mastitis, the most significant cause of economic loss to the dairy industry.