Full Press Release Details
ImmuCell Announces an Agreement Covering
the Formulation and Aseptic Filling of Syringes for Re-Tain
PORTLAND, Maine - September 11, 2019 -
ImmuCell Corporation (Nasdaq: ICCC) ("ImmuCell" or the "Company") - a growing animal health
company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity
of dairy and beef cattle - today announced that it has entered into a new agreement with Norbrook Laboratories, Limited
of Newry, Northern Ireland covering the formulation and aseptic filling of its Nisin Drug Substance into syringes for Re-Tain ,
the Company's novel treatment in development for subclinical mastitis in dairy cows.
The new agreement (which replaces an expiring agreement) expires
as of December 31, 2021 and allows for product ordered before the expiration date to be delivered into the early part of 2022.
This new agreement covers the final development work required to achieve FDA approval and also provides product for market launch.
The Company's Re-Tain production facility has been equipped to manufacture Drug Substance (the active pharmaceutical
ingredient, Nisin) with a commercial sales value of approximately $10 million per year. This new agreement with Norbrook covers
the formulation and aseptic filling of Drug Product (Nisin filled in a syringe) with a commercial sales value of approximately
$7 million. The Company is building its own Drug Product formulation and aseptic filling capability to support sales in excess
of the first $7 million.
"We have always believed that the fastest route to FDA
approval and market launch is with Norbrook," commented Michael F. Brigham, President and CEO. "At the same time, we
have initiated an investment of approximately $4 million to establish the capability of performing the Drug Product formulation
and aseptic filling in our own facility after the expiration of this new agreement with Norbrook."
Completion of the FDA's review of the first phased Drug
Substance submission of the Chemistry, Manufacturing and Controls (CMC) Technical Section was announced on August 29, 2019. One
of the key components of the second phased Drug Product CMC submission is demonstrating stability of the product over time in its
final packaged form. Given a current assessment of the work that needs to be performed and allowing for statutory review periods
by the FDA, the Company anticipates achieving FDA approval of Re-Tain during 2021.
Brigham concluded, "This is a great solution for us. We
benefit from Norbrook's world-class expertise in aseptic filling, while working to own this process in-house for the long-term,
which is the goal of both companies."
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
First Defense , providing Immediate Immunity to newborn dairy and beef livestock, and is in
the late stages of developing Re-Tain , 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.
| Contacts: | Michael F. Brigham, President and CEO |
| ImmuCell Corporation | |
| (207) 878-2770 | |
| Joe Diaz, Robert Blum and Joe Dorame | |
| Lytham Partners, LLC | |
| (602) 889-9700 | |
| iccc@lythampartners.com |
Cautionary Note Regarding Forward-Looking Statements (Safe
This Press Release contains "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to: our plans and strategies for our business; projections of future financial
performance; the value of our deferred tax assets; projections about depreciation expense and its impact on income for book and
tax return purposes; the scope and timing of ongoing and future product development work and commercialization of our products;
future costs of product development efforts; the estimated prevalence rate of subclinical mastitis; the expected efficacy of new
products; estimates about the market size for our products; future market share of and revenue generated by current products and
products still in development; our ability to increase production output and reduce costs of goods sold associated with our new
product, Tri-Shield First Defense ; the future adequacy of our own manufacturing facilities or those of third
parties with which we have contractual relationships to meet demand for our products on a timely basis; the anticipated costs of
(or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects;
the continuing availability to us on reasonable terms of third party providers of critical products or services; the robustness
of our manufacturing processes and related technical issues; estimates about our production capacity; the future adequacy of our
working capital and the availability and cost of third party financing; the timing and outcome of pending or anticipated applications
for regulatory approvals; future regulatory requirements relating to our products; future expense ratios and margins; future compliance
with bank debt covenants; future cost of our variable interest rate exposure on most of our bank debt; costs associated with sustaining
compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance
for the facility to produce the Drug Substance; factors that may affect the dairy and beef industries and future demand for our
products; implementation of international trade tariffs that could reduce the export of dairy products, which could in turn weaken
the price received by our customers for their products; our effectiveness in competing against competitors within both our existing
and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated
changes in our manufacturing capabilities and efficiencies; anticipated competitive and market conditions; and any other statements
that are not historical facts. Forward-looking statements can be identified by the use of words such as "expects",
"may", "anticipates", "aims", "intends", "would", "could",
"should", "will", "plans", "believes", "estimates", "targets",
"projects", "forecasts", "seeks" and similar words and expressions. In addition, there can
be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties,
including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory
approval, production and marketing of our products (including First Defense and Re-Tain ),
competition within our anticipated product markets, customer acceptance of our new and existing products, product performance,
alignment between our manufacturing resources and product demand, our reliance upon third parties for financial support, products
and services, changes in laws and regulations, decision making by regulatory authorities, possible dilutive impacts on existing
stockholders from any equity financing transactions in which we may engage, currency values and fluctuations and other risks detailed
from time to time in filings we make with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q,
our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based
on our current expectations, but actual results may differ materially due to various factors, including the risk factors summarized