ImmuCell Announces Completion of Construction of Nisin Production Facility
Source: Nasdaq GlobeNewswire / 07 Nov 2017 06:30:12 America/New_York
PORTLAND, Maine, Nov. 07, 2017 (GLOBE NEWSWIRE) -- 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.
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).
Michael F. Brigham, President and CEO
Joe Diaz, Robert Blum and Joe Dorame
Lytham Partners, LLC
Safe Harbor Statement:
This Press Release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to: projections of future financial performance; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis; the expected efficacy of our new products; future market share of and revenue generated by current products and products still in development; future sources of financial support for our product development, manufacturing and marketing efforts; the future adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the future adequacy of our working capital and the availability and cost of third party financing; timing and future costs of a facility to produce the Drug Substance (our active pharmaceutical ingredient, Nisin); the timing and outcome of pending or anticipated applications for regulatory approvals; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; costs associated with sustaining compliance with cGMP regulations in our current operations and attaining such compliance for the facility to produce the Drug Substance; factors that may affect the dairy and beef industries and future demand for our products; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; the accuracy of our understanding of our distributors’ ordering patterns; anticipated changes in our manufacturing capabilities and efficiencies; anticipated competitive and market conditions; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts” and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of our products, competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand, the uncertainties associated with product development and Drug Substance manufacturing, actual as compared to expected or estimated costs of expanding our manufacturing facilities, our potential reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making by regulatory authorities, possible dilutive impacts on existing stockholders from any equity financing transactions in which we may engage, currency values and fluctuations and other risks detailed from time to time in filings we make with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors discussed above.