ImmuCell Corporation announced that it has entered into a lease covering approximately 14,300 square feet of office and warehouse space effective approximately November 1, 2019. The space will be utilized to enable the Company's plan to increase the production capacity of the First Defense product line. The Company expects to have use of this new space by mid-2020 after building out the needed production rooms. The Company had considered a "build to suit" option on nearby land. This leasing option saves time and building construction costs, allowing the Company to move forward with its expansion plans more effectively and timely. The property is located nearby to the Company's facility at 56 Evergreen Drive in Portland, Maine. The lease term is ten years with a right to renew for a second ten-year term and a right of first offer to purchase. The total lease liability over the initial ten-year term aggregates approximately $1.3M before real estate and personal property taxes, utilities, insurance, maintenance and related building and operating expenses.
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.
ImmuCell Corporation announced that it has received a response from the U.S. Food and Drug Administration to its first phased Nisin Drug Substance submission of the Chemistry, Manufacturing and Controls Technical Section for Re-Tain, the Company's novel treatment in development for subclinical mastitis in lactating dairy cows. Under the FDA's phased submission process, Phase 1 concerns the Nisin Drug Substance, and Phase 2 concerns the Re-Tain Drug Product. As part of the phased submission process, the 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. This process allows a sponsor to respond to identified deficiencies from the first phased submission at the time of the second phased submission. The second phased Drug Substance and Drug Product CMC Technical Section submission is expected to be made 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. "Having reviewed the comments from the FDA, we see no road blocks on our path to FDA approval for Re-Tain," commented Michael Brigham, President and CEO. "We believe we can respond effectively to the FDA's comments without significant additional cost or time delays."
ImmuCell announced a critical milestone in the development of Re-Tain, its Nisin-based intramammary treatment of subclinical mastitis in lactating dairy cows. The company has made its first phased submission to the U.S. Food and Drug Administration of the manufacturing technical section with respect to the Nisin Drug Substance under the company's New Animal Drug Application. This submission is subject to a six-month review period and will be followed by a second phased submission covering the Nisin Drug Product, which is also subject to a six-month review period before anticipated product approval can occur. This is the fifth of five major Technical Sections required for NADA approval by the FDA and product launch. ImmuCell has previously received four Technical Section Complete Letters from the FDA, most recently for the Human Food Safety Technical Section during the third quarter of 2018. Also, the FDA recently approved "Re-Tain" as the Company's tradename for the anticipated commercial product. "This is a huge milestone for ImmuCell and for our team that has worked so hard over the past years to develop and optimize the manufacturing process and to design, construct and qualify our new Drug Substance facility," commented Elizabeth L. Williams, Vice President of Manufacturing Operations. "The capstone was the recent manufacture and analysis of Registration Batches bridging back to the pivotal batches used in key studies. Our team has persisted through the many stages of development and has consistently demonstrated the needed tenacity, creativity and energy to reach this milestone. I am honored to work with them."