ImmuCell Corporation (Nasdaq:ICCC), a growing
animal health company that develops, manufactures and markets
scientifically-proven products that improve the health and
productivity of dairy and beef cattle, today announced that
the USDA, Center for Veterinary Biologics, approved licensure for
the first calf-level scours preventative with claims against all
three newborn calf scours (diarrhea) causing pathogens, E. coli,
coronavirus and rotavirus.
The new product, First Defense® Tri-Shield™,
combines the E. coli and coronavirus antibodies contained in
ImmuCell’s legacy product, First Defense®, with a
guaranteed minimum level of rotavirus antibody content in one
preventative dose. This unique breadth of claims further
differentiates the ImmuCell product from competitive products on
the market that have claims against both coronavirus and rotavirus
or just E. coli or just coronavirus, but not all three.
Preventing scours in newborn calves reduces the need to use
treatment antibiotics later in life. This new product will be
available in a gel tube delivery format.
“This is a very important achievement by our development and
manufacturing teams after many years of challenging work,”
commented Michael F. Brigham, President and CEO. “Generating
a consistent level of rotavirus antibodies through our proprietary
hyper-immunization program is not easy. This result utilizes
the novel technology that we have exclusively licensed from the
Baylor College of Medicine in Houston.”
No other calf-level product contains all three important health
claims in a one-time preventative dose. With this expanded
claim set, the Company can compete more effectively against
dam-level scours vaccine products that are given to the cow to
improve the quality of her colostrum (first milk) that is fed to
the newborn. However, it is generally believed that only 80%
of animals respond to a vaccine, which leaves about 20% of calves
unprotected. Additionally, our research suggests that
treatment protocols for dam-level vaccine programs are not always
followed, leaving even more calves compromised. The Company’s
new marketing campaign, ‘Beyond Vaccination™’,
suggests that by delivering immediate immunity directly to the calf
via Tri-Shield™, producers can save needles and
labor for vaccines that are more critical to cow health.
“‘Beyond Vaccination™’ is a bold claim but very
valid for this product,” commented Ms. Bobbi Jo Brockmann, Vice
President of Sales & Marketing. “For the longest time,
the primary tool to help combat scours was vaccinating the cow with
a scours vaccine intended to protect the calf through colostrum,
but when you depend on a dam-level scours vaccine, you need to
spend that money before you know if you have a viable, valued
calf. With First Defense® Tri-Shield™, every
calf is equally protected and that investment can be targeted to
the calves that are most critical to the operation. This, in
turn, can free up space in the cow’s vaccination schedule to
optimize her immune response to vaccines that are most critical to
her health. With Tri-Shield™, we are ready
to break tradition with a better way to protect calves.”
Update on New Mastitis Product:A Certificate of
Occupancy was issued by the City of Portland, Maine on October 30,
2017 for the Company’s Nisin production facility. On November
8, 2017, the Company held a ‘ribbon-cutting’ ceremony to celebrate
the completion of the construction phase of this $21 million
project. This facility will be used by ImmuCell to produce
purified, pharmaceutical-grade Nisin Drug Substance at commercial
scale. Adherence to the Company’s anticipated timeline could lead
to potential approval by the end of 2019 with subsequent market
launch.
Conference Call: Interested parties can access
the conference call scheduled by the Company to review the
financial results for the third quarter of 2017 by dialing (844)
855-9502 (toll free) or (412) 317-5499 (international) at 4:30 PM
ET today. A teleconference replay of the call will be available for
six days at (877) 344-7529 (toll free) or (412) 317-0088
(international), confirmation #10113568.
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 has developed products that
provide significant, immediate immunity to newborn dairy and beef
livestock. The Company is 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).
Contacts:
Michael F. Brigham, President and CEOImmuCell Corporation(207)
878-2770
Joe Diaz, Robert Blum and Joe DorameLytham Partners, LLC(602)
889-9700iccc@lythampartners.com
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:
projections of future financial performance; 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; future market
share of and revenue generated by current products and products
still in development; future sources of financial support for our
product development, manufacturing and marketing efforts; 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 future adequacy of
our working capital and the availability and cost of third party
financing; timing and future costs of a facility to produce the
Drug Substance (our active pharmaceutical ingredient, Nisin); 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; costs associated with sustaining
compliance with 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; 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; the accuracy of our
understanding of our distributors’ ordering patterns; 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” 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, competition within our anticipated product
markets, customer acceptance of our new and existing products,
product performance, alignment between our manufacturing resources
and product demand, the uncertainties associated with product
development and Drug Substance manufacturing, actual as compared to
expected or estimated costs of expanding our manufacturing
facilities, our potential 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 are based on our
current expectations, but actual results may differ materially due
to various factors, including the risk factors discussed above.
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