ImmuCell Corporation(Nasdaq:ICCC), a growing animal health company that develops, manufactures and markets scientifically-proven products that improve the health and productivity of dairy and beef cattle, today announced completion of the construction phase of its Nisin production facility and that installation of process equipment has progressed significantly.
A Certificate of Occupancy for this facility was issued by the City of Portland, Maine on October 30, 2017. A ‘ribbon-cutting’ ceremony will be held on the site at 33 Caddie Lane in Portland on Wednesday, November 8, 2017 at 11:00 AM. The public is invited to attend. A facility tour will be offered. Mr. Walter E. Whitcomb, Commissioner of the Maine Department of Agriculture, Conservation and Forestry, is expected to attend the event and offer comments. Several officials from the City of Portland are also expected to attend to see the structure that the City helped support with a Tax Increment Financing (‘TIF’) benefit.
“This is a significant milestone on a project worth over $20 million. We are right on the planned timeline and within a few percentage points of the dollar budget,” said Michael F. Brigham, President and CEO. “We are proud to be bringing a unique, FDA-Registered Drug Establishment to the State of Maine.”
“We have come a long way since breaking ground in September of 2016,” commented Elizabeth L. Williams, vice president of manufacturing operations for ImmuCell, who is in charge of this project. “This would not be possible without the top-quality work performed by the multiple contractors that participated with us on the project. We extend our sincere appreciation to all of them for a job well done.”
Financing for this project was provided by the Company’s stockholders and by TD Bank N.A. ImmuCell wishes to thank the over 30 contractors and sub-contractors and equipment providers that have worked on this project led by Consigli Construction Co., Inc. of Portland, Maine and the design and engineering firm of Stantec of Albany, New York.
The active ingredient, Nisin, to be produced in this facility will form the Drug Substance for a novel treatment for subclinical mastitis in lactating dairy cows that can be administered without a milk discard or meat withhold requirement (which is a label requirement for all traditional antibiotics on the market today). The Company expects equipment installation and qualification to be complete by year end. Commercial-scale process validation batches must be produced, a detailed manufacturing Technical Section must be prepared and submitted to the FDA and successful FDA site inspections must be achieved. The Company anticipates making the first submission to the FDA during the middle of 2018. It is expected that two submissions will be required. Each submission is subject to a six-month review by the FDA. After approval of this manufacturing Technical Section, there is a 60-day administrative review before product license approval can be issued. Adherence to this anticipated timeline could lead to potential approval by the end of 2019 with subsequent market launch.
About ImmuCell: ImmuCell Corporation's (Nasdaq:ICCC) purpose is to create scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell has developed products that provide significant, immediate immunity to newborn dairy and beef livestock. The Company is developing a novel treatment for mastitis, the most significant cause of economic loss to the dairy industry. Press releases and other information about the Company are available at: (http://www.immucell.com).