ImmuCell Receives FDA Response To First CMC Submission for Re-Tain™
August 29 2019 - 8:00AM
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 received a response from
the U.S. Food and Drug Administration (FDA) to its first phased
Nisin Drug Substance submission of the Chemistry, Manufacturing and
Controls (CMC) Technical Section for
Re-Tain™, the
Company’s novel treatment in development for subclinical mastitis
in lactating dairy cows.
Under the FDA’s phased submission process, Phase 1
concerns the Nisin Drug Substance, and Phase 2 concerns the
Re-Tain™ Drug Product (formulated Nisin filled in
a syringe). As part of the phased submission process, the FDA
issued a Technical Section Incomplete Letter with various requests
and queries in addition to referring to the fact that the second
phased submission has yet to be submitted. This process allows a
sponsor to respond to identified deficiencies from the first phased
submission at the time of the second phased submission. The second
phased Drug Substance and Drug Product CMC Technical Section
submission is expected to be made around the third quarter of 2020.
In addition to responding to comments raised by the FDA regarding
the first phased submission, one of the key components of the
second phased submission is demonstrating stability of the product
over time using the commercial process and the commercial
syringe.
“Having reviewed the comments from the FDA, we see no road
blocks on our path to FDA approval for Re-Tain™,”
commented Michael F. Brigham, President and CEO. “We believe we can
respond effectively to the FDA’s comments without significant
additional cost or time delays.”
Having previously achieved four different Technical Section
Complete Letters from the FDA, approval of the CMC Technical
Section is the fifth and final significant step required before
Re-Tain™ product sales can be initiated in the
U.S.
About ImmuCell: 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.
Cautionary Note Regarding Forward-Looking Statements
(Safe Harbor Statement):
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 timing and outcome of pending or
anticipated applications for regulatory approvals; factors that may
affect the dairy and beef industries and future demand for our
products; 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; 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 Nisin Drug Substance;
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; the value of
our net deferred tax assets; projections about depreciation expense
and its impact on income for book and tax return purposes;
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 the First Defense®
product line 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,
currency values and fluctuations and other risks detailed from time
to time in filings we make with the SEC, 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 above.
Contacts: |
Michael F. Brigham, President and CEO |
Joe Diaz, Robert Blum and Joe Dorame |
|
ImmuCell Corporation |
Lytham Partners, LLC |
|
(207) 878-2770 |
(602) 889-9700 |
|
|
iccc@lythampartners.com |
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