PORTLAND, ME--(Marketwired - Sep 17, 2014) - ImmuCell Corporation (
The Company will be participating in the:
All American Dairy Show, September 13 - 18, in Harrisburg, Pennsylvania;
American Association of Bovine Practitioners Conference, September 18-20, in Albuquerque, New Mexico;
2014 World Beef Expo, September 26 - 28, in Milwaukee, Wisconsin; and
2014 World Dairy Expo, September 30 - October 4, in Madison, Wisconsin.
Bobbi Jo Brockmann, director of sales and marketing, said, "This is an exciting time of the year for ImmuCell. These events afford opportunity, in addition to regular farm visits, to interface directly with our customers and distributors to bring them up to date on the value proposition that ImmuCell products provide to dairy and beef operators and their herds. With milk futures prices currently at all-time highs and strong beef prices, the benefits of First Defense ® to help newborn calves maximize their ability to become healthy and highly productive milk and beef producers becomes even more compelling."
"These are vital interactions in that they drive orders through our distribution channel as we approach the spring beef calving season which takes place in the March through May time frame. These events also provide our expanded sales and marketing team the opportunity to unite as a group and show our customers and distribution chain how we now have representation from all of the major cattle pockets in the U.S."
Ms. Brockmann continued, "Presence at these industry events also creates important corporate brand awareness as we continue to progress toward Food and Drug Administration (FDA) approval of Mast Out ® to address subclinical mastitis in lactating cows. Subclinical and clinical mastitis costs the U.S. dairy industry upwards of $2 billion annually in treatment costs and lost milk revenue, among other issues. Mast Out ® may provide a unique and effective solution to treat infections in their herd without the use of traditional antibiotics and without having to discard milk, driving a significant economic advantage. With Mast Out ® , we expect to offer a powerful value proposition, and we look forward to bringing this important solution to the market."
ImmuCell has commenced validation and testing of processing equipment necessary to complete the manufacturing requirements of the New Animal Drug Application (NADA) submission to the FDA. The Company expects to make its first submission of the Chemistry, Manufacturing and Controls (CMC) Technical Section to the FDA during the first half of 2015. At the same time, Company scientists are working with the FDA to transfer the analytical method to detect Nisin in milk to an FDA laboratory. Once this method is successfully transferred, the Company expects to receive the Human Food Safety Technical Section Complete Letter from the FDA. These are the final two steps in the NADA process, as Mast Out ® has previously received the following from the FDA:
- Environmental Impact Technical Section Complete Letter;
- Target Animal Safety Technical Section Complete Letter;
- Effectiveness Technical Section Complete Letter; and
- A zero milk discard and zero meat withhold claim.
The Company anticipates two, six-month reviews of the CMC Technical Section submission by the FDA, setting up potential NADA approval from the FDA during 2016. This would allow test marketing of Mast Out ® in 2016.
About ImmuCell
ImmuCell Corporation's (
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 future product development work and commercialization of our products; the future adequacy of our working capital and the availability of third party financing; the outcome of pending or anticipated applications for future regulatory approvals; factors that may affect the dairy and beef industries and future demand for our products; 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, the uncertainties associated with product development, pharmaceutical-grade Nisin manufacturing, our potential reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making by regulatory authorities 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.
Contact: Michael F. Brigham President and CEO (207) 878-2770 Joe Diaz, Robert Blum and Joe Dorame Lytham Partners, LLC (602) 889-9700 Email Contact
