ImmuCell Awarded Grant Support for MAST OUT.Business/Technology Editors and Health/Medical Writers PORTLAND, Maine--(BW HealthWire)--June 6, 2001 ImmuCell Corporation (NASDAQ/ICCC) today announced that it has been awarded a one year grant aggregating $196,000 from the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS to augment the Company's development of its Nisin-based mastitis mastitis (măstī`tĭs), inflammation of the breast. Mastitis most commonly occurs in nursing mothers between the first and third weeks after childbirth, usually of the first child. treatment, MAST OUT(TM). Funded under the Small Business Innovation Research Program at the National Institutes of Health ("NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. "), this award supports a significant portion of the costs related to conducting the clinical trials required to obtain FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of the product application for lactating cows. "This NIH award recognizes the important potential of our technology to curb the growth of antimicrobial resistance and enables us to aggressively accelerate the development of the product," commented Dr. Richard T. Coughlin, senior director of research and development. "This product, which is subject to FDA approval, could fit very well with our growing line of products aimed at improving animal health and productivity in the dairy and beef industry." Additionally, the Company recently was awarded a $70,000 grant over eighteen months from the United States Department of Agriculture United States Department of Agriculture (USDA), n.pr established in 1862, USDA is responsible for the safety of meat, poultry, and egg products. It conducts ongoing research in areas from human nutrition to new crop technologies and also helps ensure open to fund a portion of the expenses related to clinical trials of a dry cow application of this technology. In March 2001, the Company announced that it had been awarded up to $400,000 in funding over two years from the Maine Technology Institute. This grant award carries a contingent pay back obligation. Within two years of product commercialization, the Company may elect to pay back the grant amount or alternatively it may elect to pay a 2% royalty on sales until the accumulated royalty paid aggregates two times the grant amount. Currently, this grant funding is being accounted for as deferred revenue. If the product supported by this grant is not commercialized, there would be no pay back obligation. Therefore, the deferred revenue would be recognized as grant income at that time. Estimated losses to the U.S. dairy industry associated with mastitis are thought to range from $1 to 2 Billion per year. If successfully developed and commercialized, the Company believes that MAST OUT could be the first non-antibiotic product approved for the treatment of mastitis (inflammation of the mammary gland). The U.S. mastitis treatment market is estimated to be worth at least $20,000,000 per year for lactating cows. The Company believes the dry cow application may represent a similar sized market opportunity. The treatment of bovine mastitis with a Nisin-based product could help address the growing concern about the overuse of antibiotics in food animals. The Company currently markets WIPE OUT(R) Dairy Wipes, a pre-moistened teat teat (tet) nipple (1). teat n. 1. See nipple. 2. The female breast; mamma. 3. A papilla. wipe product impregnated im·preg·nate tr.v. im·preg·nat·ed, im·preg·nat·ing, im·preg·nates 1. To make pregnant; inseminate. 2. To fertilize (an ovum, for example). 3. with Nisin nisin an antibiotic substance isolated from cultures of lactic acid producing streptococci and reputed to have antibacterial activity against gram-positive bacteria. and used by dairy producers to aid in the prevention of mastitis. The Company also markets a California Mastitis Test California mastitis test an indirect test for bovine mastitis based on the presence of a high leukocyte count in mastitic milk. The test can be used in the milking shed or in the laboratory and as a test for individual quarters, or cows, or as a herd test. to screen for bovine mastitis and MASTiK(TM), a product that helps veterinarians and dairy producers select an effective antibiotic for use in treatment of mastitis. In April 2000, the Company entered into an exclusive license and option agreement with Nutrition 21, Inc. of Purchase, New York Purchase, New York is a hamlet of the town of Harrison, in Westchester County. Its Zip code is 10577. Purchase is home to Purchase College, which is part of the State University of New York system, Manhattanville College, a private liberal arts college, and the headquarters providing the Company with worldwide rights to develop and market new antibacterial products for animals using Nutrition 21's Nisin and lysostaphin technologies. MAST OUT(TM), which is the first product development target under these rights, would use Nisin as a mastitis treatment in dairy cows. ImmuCell Corporation is a biotechnology company dedicated to benefiting its employees and shareholders through innovative and proprietary products that improve animal health and productivity in the dairy and beef industry. In addition to operating a growing and profitable animal health business, the Company recently obtained U.K. regulatory approval to sell Crypto-Scan(R), a product that is used in the detection of Cryptosporidium cryptosporidium (krĭp'tōspərĭd`ēəm), genus of protozoans having at least four species; they are waterborne parasites that cause the disease cryptosporidiosis. in drinking water. Further, the Company has demonstrated preliminary efficacy in an open label, Phase I/II efficacy study of DiffGAM, an alternative to antibiotics in the treatment and/or prevention of Clostridium clostridium Any of the rod-shaped, usually gram-positive bacteria (see gram stain) that make up the genus Clostridium. They are found in soil, water, and the intestinal tracts of humans and other animals. Some species grow only in the complete absence of oxygen. difficile-associated diarrhea in humans. Certain nutritional rights to the DiffGAM technology have been licensed to a corporate partner. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, which are statements of future expectations and not facts. Actual results or developments might differ materially from those included in the forward-looking statements because of factors such as the ability of the Company to achieve grant milestones, incorrect market estimates, product efficacy, competition, changes in economic conditions, changes in regulatory policies, technological developments and other presently unknown or unforeseen factors. Other risk factors are detailed from time to time in the Company's reports to the Securities and Exchange Commission. ImmuCell Corporation press releases and other information about the Company are available at its corporate web site at http://www.ImmuCell.com. |
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