Necessary facility upgrades completed; Process validation and optimization to complete manufacturing objectives of regulatory submission initiated
ImmuCell Corporation (NasdaqCM: 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 completed modifications to its manufacturing facility to produce pharmaceutical-grade Nisin, the active ingredient in its Mast Out® product, to address subclinical mastitis in lactating dairy cows.
ImmuCell (the Company) will commence validation and testing of the new facility and processing equipment to complete the manufacturing requirements of the New Animal Drug Application (NADA) submission to the Food and Drug Administration (FDA). Once this data has been compiled, the Company expects to make its first submission of the Chemistry, Manufacturing and Controls (CMC) Technical Section to the FDA around the end of calendar year 2014. 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:
· The Environmental Impact Technical Section Complete Letter;
· The Target Animal Safety Technical Section Complete Letter;
· The 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 during 2015, setting up potential NADA approval from the FDA during 2016. This would allow test marketing of Mast Out® in 2016.
Michael F. Brigham, President and CEO of ImmuCell, commented, "We are pleased with the progress achieved during the first half of fiscal 2014 in completing the necessary modifications to our manufacturing facilities on time and on budget. We will now begin to utilize the newly installed equipment and space to demonstrate to the FDA our ability to effectively produce pharmaceutical-grade Nisin while verifying process yields."
Mastitis is considered the costliest disease to the U.S. dairy industry and major dairy producing regions of the world. Annual losses are presently estimated to be upwards of $2 Billion in the United States alone. These losses are comprised of reduced milk production, discarded milk, replacement animals, labor, drug treatments and veterinarian services. Mastitis refers to an inflammation of the udder, most commonly caused by a bacterial infection. This infection is commonly treated with traditional antibiotics. Mast Out®, an intramammary infusion product containing Nisin, is under development as an alternative to traditional antibiotics for the treatment of subclinical mastitis in lactating cows. The safety profile of Nisin may allow for the use of Mast Out® in the United States without "milk discard" or "meat withhold" requirements.
In late 2013, the Company announced a $3 Million capital improvement investment, allocating approximately half of this total to build out modifications of its facility and acquire equipment necessary to produce pharmaceutical-grade Nisin for Mast Out®. The remaining amount has been allocated to a 7,100 square foot facility addition intended to increase production capacity for current products, maintain compliance with current Good Manufacturing Practice (cGMP) regulations in all operations and integrate the production of pharmaceutical-grade Nisin. The Company is preparing to break ground on this second project during the third quarter of 2014.
ImmuCell Corporation's (NasdaqCM: 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