EMBX Embrex

RESEARCH TRIANGLE PARK, N.C., April 24 /PRNewswire-FirstCall/ -- Embrex(R), Inc., The In Ovo Company(R), (NASDAQ:EMBX) today announced that the U.S. Department of Agriculture (USDA) granted Embrex's Inovocox(TM) coccidiosis vaccine for poultry a Veterinary Biological Product License which allows the Company to market and sell the product in the United States. Simultaneously, the USDA granted a Veterinary Biologics Establishment License to Embrex Poultry Health LLC, the Company's manufacturing subsidiary based in Scotland County, North Carolina, where the new vaccine will be manufactured, packaged and shipped to customers. Inovocox(TM) vaccine is a novel in ovo vaccine that allows poultry producers to take further advantage of the Embrex Inovoject(R) injection system, an automated device that can deliver multiple vaccines to a chick while it is still in the egg. Inovocox(TM) can be delivered to poultry safely, precisely and uniformly in the controlled environment of the hatchery through the Inovoject(R) system. It offers protection to the bird in a single dose against three of the most common species of coccidia. In addition, Inovocox(TM) vaccine can be safely delivered in combination with other vaccines, such as Marek's vaccine which is commonly delivered in ovo via Embrex's Inovoject(R) system to more than 85% of U.S. broiler chickens to prevent Marek's disease. "This marks an important milestone for Embrex and opens up new doors for producers who wish to utilize Inovoject(R) systems already operating in their hatcheries to vaccinate against this parasitic disease while the bird is still in the egg," said Randall L. Marcuson, President and Chief Executive Officer of Embrex. "We believe this provides an innovative, cost-effective, and highly beneficial in ovo tool as an aid in the prevention of this important disease". The Embrex Inovocox(TM) technical and commercial team plans to implement a series of commercial-scale product demonstration trials in order to introduce this unique product to the U.S. poultry industry. About the Manufacturing Facility Embrex has invested approximately $15 million to design and build Embrex Poultry Health's manufacturing facility for Inovocox(TM) vaccine, in Scotland County, North Carolina. This plant, the first bio-manufacturing facility built by a home-grown North Carolina based bio-technology company, houses vaccine purification, sterile filling, shipping and receiving, as well as quality control laboratories. Certain aspects of the novel manufacturing process are unique and proprietary to Embrex. Currently, Embrex Poultry Health employs approximately 20 people, targeting growth to nearly 40 when in full production. Coccidiosis Coccidiosis is a parasitic disease of the chicken's digestive system. While seldom fatal, it causes weight depression, lower feed conversion ratios, intestinal lesions and diarrhea. The Company estimates that the market for existing products to treat coccidiosis worldwide is approximately $350 million. Marketing this product outside the U.S. will also require the Company to obtain separate approvals from regulatory agencies in other countries. About Embrex Founded in 1985, Embrex(R), Inc., The In Ovo Company(R), headquartered in Research Triangle Park, NC, is an international agricultural biotechnology company engaged in the development of innovative in ovo (in the egg) solutions that meet the needs of today's global poultry industry. The Company's unique integration of several scientific and engineering disciplines enables it to be the leading provider of in ovo, value-added solutions with its automated injection and detection devices as well as its select vaccines. For additional information, visit the company web site at http://www.embrex.com/. This release contains forward-looking statements, including statements with respect to future financial results, products, services, and markets. These statements involve risks and uncertainties that could cause actual results to differ materially. Risks include without limitation the degree of growth in the poultry industry in the United States and globally, competition arising in the United States and elsewhere, possible decreases in production by our customers, avian disease outbreaks in Embrex's markets, market acceptance and cost of expansion in new geographic markets and with new products, such as Newplex(TM) and Inovocox(TM), and the ability of Embrex's contract manufacturers to support such products. Additional risks include the Company's ability to penetrate new markets and the degree of market acceptance of new products, the complete commercial development of potential future products on a cost effective basis, including Inovocox(TM), the availability of adequate supplies, and the ability to obtain regulatory approval of products. Such approval is dependent upon a number of factors, such as results of trials, the discretion of regulatory officials, and potential changes in regulations. Additional information on these risks and other factors, which could affect the Company's financial results, is included in the Company's Forms 10-K, 10-Q and other filings with the Securities and Exchange Commission. Embrex(R), Inovoject(R), Newplex(TM), Inovocox(TM) and The In Ovo Company(R) are trademarks of Embrex, Inc. Contact: Randall Marcuson President & CEO 919-941-5185 DATASOURCE: Embrex, Inc., The In Ovo Company CONTACT: Randall Marcuson, President & CEO of Embrex, Inc., The In Ovo Company, +1-919-941-5185 Web site: http://www.embrex.com/

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