Embrex Inc., The In Ovo Company, today announced that the U.S. Department of Agriculture (USDA) granted Embrex's Inovocox 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 vaccine is a novel in ovo vaccine that allows poultry producers to take further advantage of the Embrex Inovoject injection system, an automated device that can deliver multiple vaccines to a chick while it is still in the egg. Inovocox can be delivered to poultry safely, precisely and uniformly in the controlled environment of the hatchery through the Inovoject system. It offers protection to the bird in a single dose against three of the most common species of coccidia. In addition, Inovocox 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 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 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 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.
Embrex has invested approximately $15 million to design and build Embrex Poultry Health's manufacturing facility for Inovocox 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 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.