Immucell announces agreement covering formulation for Re-Tain
ImmuCell Corporation announced that it has entered into a new agreement with Norbrook Laboratories, Limited of Newry, Northern Ireland covering the formulation and aseptic filling of its Nisin Drug Substance into syringes for Re-Tain, the Company's novel treatment in development for subclinical mastitis in dairy cows. The new agreement expires as of December 31, 2021 and allows for product ordered before the expiration date to be delivered into the early part of 2022. This new agreement covers the final development work required to achieve FDA approval and also provides product for market launch. The Company's Re-Tain production facility has been equipped to manufacture Drug Substance with a commercial sales value of approximately $10M per year. This new agreement with Norbrook covers the formulation and aseptic filling of Drug Product with a commercial sales value of approximately $7M. The Company is building its own Drug Product formulation and aseptic filling capability to support sales in excess of the first $7M Completion of the FDA's review of the first phased Drug Substance submission of the Chemistry, Manufacturing and Controls Technical Section was announced on August 29, 2019. One of the key components of the second phased Drug Product CMC submission is demonstrating stability of the product over time in its final packaged form. Given a current assessment of the work that needs to be performed and allowing for statutory review periods by the FDA, the Company anticipates achieving FDA approval of Re-Tain during 2021.