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ImmuCell updates business, regulatory status

Company leases facility under plan to expand production capacity and signs agreement for pending mastitis product.

ImmuCell Corp. announced that it has entered into a lease covering approximately 14,300 sq. ft. of office and warehouse space, effective on approximately Nov. 1, 2019.

According to the announcement, the space will be utilized to enable the company’s plan to increase production capacity of its First Defense product line. ImmuCell 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 ImmuCell to move forward with its expansion plans more effectively and timely, the announcement said.

“Accessing this property is part of our $3 million investment in First Defense to increase the sales value of our annual production capacity from approximately $18 million to approximately $27 million,” said Michael F. Brigham, ImmuCell president and chief executive officer. “By moving the final product formulation, filling and assembly for First Defense to the leased building, we free up ample space in our current facility to increase liquid processing capacity by 100% and freeze drying capacity by 50%.”

The property is located near ImmuCell’s facility in Portland, Maine. The lease has a 10-year term, with a right to renew for a second 10-year term and a right of first offer to purchase. The total lease liability over the initial 10-year term (including inflationary adjustments) aggregates approximately $1.3 million before real estate and personal property taxes, utilities, insurance, maintenance and related building and operating expenses, ImmuCell said.

ImmuCell also recently announced that it has entered into a new agreement with Norbrook Laboratories Ltd. 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.

ImmuCell said the new agreement (which replaces an expiring agreement) expires as of Dec. 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 Food & Drug Administration approval and also provides product for market launch.

The company’s Re-Tain production facility has been equipped to manufacture the drug substance (the active pharmaceutical ingredient, or nisin) with a commercial sales value of approximately $10 million per year, the announcement said.

This new agreement with Norbrook covers the formulation and aseptic filling of the 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 beyond the first $7 million.

“We have always believed that the fastest route to FDA approval and market launch is with Norbrook,” Bringham said. “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 review of the first phased drug substance submission of the chemistry, manufacturing and controls technical section was announced Aug. 29, 2019. Given a current assessment of the work that needs to be performed and allowing for statutory review periods by FDA, ImmuCell said it anticipates achieving FDA approval of Re-Tain during 2021.

ImmuCell's purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. It 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.

Source: ImmuCell, which is solely responsible for the information provided and is wholly owned by the source. Informa Business Media and all its subsidiaries are not responsible for any of the content contained in this information asset.
TAGS: Business
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