World News: 13:00 GMT Wednesday 11th September 2019. [ImmuCell Corporation via Globe Newswire via SPi World News]
The new agreement (which replaces an expiring 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 ™ production facility has been equipped to manufacture Drug Substance (the active pharmaceutical ingredient, Nisin) with a commercial sales value of approximately $10 million per year. This new agreement with Norbrook covers the formulation and aseptic filling of Drug Product (Nisin filled in a syringe) with a commercial sales value of approximately $7 million. The Company is building its own Drug Product formulation and aseptic filling capability to support sales in excess of the first $7 million.
“We have always believed that the fastest route to FDA approval and market launch is with Norbrook,” commented Michael F. Brigham, President and CEO. “At the same time, we have initiated an investment of approximately $4 million to establish the capability of performing the Drug Product formulation and aseptic filling in our own facility after the expiration of this new agreement with Norbrook.”
Completion of the FDA’s review of the first phased Drug Substance submission of the Chemistry, Manufacturing and Controls (CMC) 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 ™ during 2021.
Brigham concluded, “This is a great solution for us. We benefit from Norbrook’s world-class expertise in aseptic filling, while working to own this process in-house for the long-term, which is the goal of both companies.”
Globe Newswire: 13:00 GMT Wednesday 11th September 2019
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