The Company has made its first phased submission to the U.S. Food and Drug Administration (FDA) of the manufacturing technical section (known as the Chemistry, Manufacturing and Controls (CMC) Technical Section) with respect to the Nisin Drug Substance under the Company’s New Animal Drug Application (NADA). This submission is subject to a six-month review period and will be followed by a second phased submission covering the Nisin Drug Product, which is also subject to a six-month review period before anticipated product approval can occur. This is the fifth of five major Technical Sections required for NADA approval by the FDA and product launch. ImmuCell has previously received four Technical Section Complete Letters from the FDA, most recently for the Human Food Safety Technical Section during the third quarter of 2018. Also, the FDA recently approved “Re-Tain™” as the Company’s tradename for the anticipated commercial product.
“This is a huge milestone for ImmuCell and for our team that has worked so hard over the past years to develop and optimize the manufacturing process and to design, construct and qualify our new Drug Substance facility,” commented Elizabeth L. Williams, Vice President of Manufacturing Operations. “The capstone was the recent manufacture and analysis of Registration Batches bridging back to the pivotal batches used in key studies. Our team has persisted through the many stages of development and has consistently demonstrated the needed tenacity, creativity and energy to reach this milestone. I am honored to work with them.”
This Technical Section includes data from the Nisin Drug Substance (the active pharmaceutical ingredient) Registration Batches produced at commercial scale in the Company’s new manufacturing facility. The timing of this first comprehensive and complex submission will not itself impact the regulatory timeline because the second phased Nisin Drug Product submission defines the critical path to product approval.
The second phased Nisin Drug Product submission will not be made in time to achieve product approval by December 2019 due to unexpected difficulties and delays at this stage of the Drug Product development. In order to facilitate the fastest path to market, the Company has made requests to its third-party manufacturer to modify certain provisions of its agreement, including the provision entitling the manufacturer to terminate the agreement if FDA approval is not achieved by December 17, 2019. Any such amendment could increase manufacturing costs or shorten the term during which those manufacturing services remain available to the Company.
At the same time, the Company is actively investigating multiple paths to secure alternative FDA-approved manufacturing services for the Nisin Drug Product, including, but not limited to, finding another qualified third party or performing the services in-house by installing filling equipment in the Company’s new Drug Substance facility. The latter option would provide the Company the longer-term advantage of controlling the entire production process in one facility (thereby, ultimately reducing manufacturing costs), but it would require additional capital to be raised. Both alternate paths could extend the timeline to FDA approval past the currently projected goal of the first half of 2020 and could cause interruptions to the production and sale of Re-Tain™.
“We are working through these challenges. In the meantime, we are fortunate for the growth in our First Defense® product line and are working to capitalize on that opportunity over the near-term,” added Michael F. Brigham, President and CEO. “Our longer-term goal is to revolutionize mastitis treatment practices with Re-Tain™, by reducing the use of traditional antibiotics in food-producing animals and making the early treatment of sick animals economically feasible by removing the milk discard penalty that is incurred whenever a cow is treated with any of the common antibiotics on the market today.”
Nisin is a bacteriocin that is not used in human medicines and could alleviate some of the social concerns that the widespread use of antibiotics encourages the growth of antibiotic-resistant bacteria (“superbugs”). Mastitis, which costs the dairy industry about $2 billion per year, is currently treated with traditional antibiotic products, and treatment is generally reserved for clinical infections when the cow produces non-saleable milk. The “zero milk discard” product feature approved for Re-Tain™ would make earlier treatment of sick cows economically feasible, while these cows are still producing saleable milk. No other existing product can provide this kind of value proposition.
ImmuCell Corporation's (Nasdaq: ICCC) purpose is to create scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell markets products that provide Immediate Immunity™ to newborn dairy and beef livestock and is in the late stages of developing a novel treatment for mastitis, the most significant cause of economic loss to the dairy industry. Press releases and other information about the Company are available at: http://www.immucell.com.