PORTLAND, ME -- (Marketwired) -- 07/15/14 -- ImmuCell Corporation (NASDAQ: ICCC) a growing animal health company that is developing, manufacturing and selling products that improve animal health and productivity in the dairy and beef industries, announced today that it has commenced a pivotal effectiveness study designed to test antibodies derived from colostrum utilizing its proprietary technology against a bovine rotavirus challenge. The enrollment of calves for the pivotal effectiveness study is expected to be complete by the end of 2014, making product approval possible in 2015.
The study was initiated at Cornell University during the second quarter of 2014. The underlying rotavirus vaccine technology used to generate the specific antibodies has been licensed exclusively to ImmuCell (the Company) from the Baylor College of Medicine. The Company's commercial objective -- which is subject to review and approval by the USDA -- is to manufacture and market a unique colostrum replacer product with USDA-approved claims against E. coli, coronavirus and rotavirus in addition to Failure of Passive Transfer.
ImmuCell's First Defense®product delivers Immediate Immunity to newborn calves against E. coli and coronavirus infections, reducing morbidity and mortality caused by scours (diarrhea). Scours-afflicted calves are compromised for the remainder of their lives, rarely achieving their optimal weight potential and milk production. First Defense® provides maximal protection when used during the first 12 hours after birth in conjunction with good colostrum feeding and calf nutrition programs. ImmuCell hopes to expand its First Defense® product line with the addition of what would be the only product of its kind on the market with claims against E. coli, coronavirus, rotavirus and Failure of Passive Transfer.
Michael F. Brigham, President and CEO of ImmuCell, commented, "We continue to build upon the First Defense® franchise, which has gained solid traction in the marketplace in recent years. Farmers understand the value proposition of our First Defense® product, and it is in our best interest to expand the product line. We have added new regional sales managers in Wisconsin and California because we believe that further growth opportunities exist for First Defense®. We are excited about the possibilities ahead."
ImmuCell Corporation's (NASDAQ: ICCC) purpose is to create scientifically-proven and practical products that improve animal health and productivity in the dairy and beef industries. ImmuCell has developed products that provide significant immediate immunity to newborn dairy and beef livestock. The Company has also developed products that address mastitis, the most significant cause of economic loss to the dairy industry. Press releases and other information about the Company are available at our web-site, (http://www.immucell.com).
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.