ImmuCell's Mastitis Drug Meets Pivotal Effectiveness Study End Point
PORTLAND, ME--(Marketwire - September 30, 2009) - ImmuCell Corporation (NASDAQ: ICCC) today
announced initial results from its pivotal effectiveness study of Mast
Out®. All data, results and conclusions discussed in this press release
are subject to review and approval by the U.S. Food and Drug Administration
(FDA), Center for Veterinary Medicine.
In a study of approximately 300 qualified cows with subclinical mastitis
that was conducted at sixteen sites across the United States, the Mast
Out® treatment group showed a statistically highly significant (p <
0.0001) overall cure rate in comparison to the placebo group. The
preliminary breakdown of the data by species suggests both the necessary
numerical superiority and clinical relevancy to support robust product
performance in the field. The primary objective of this study was to
demonstrate effectiveness in the field, at a level similar to currently
marketed intramammary antibiotics.
"We accomplished our objective and confirmed results from two major field
studies conducted since 2003," commented Michael F. Brigham, President and
CEO. "The main competitive advantage of Mast Out® is that it may qualify
for use in the United States without a requirement to discard milk or
withhold meat from human consumption for the period of treatment and for a
defined period of time thereafter. All mastitis treatment products on the
market today are sold subject to such 'discard' and 'withhold'
These positive results justify a continued product development effort.
Commercial introduction of Mast Out® in the United States is subject to
review and approval of a New Animal Drug Application (NADA) by the FDA,
which approval cannot be assured. The NADA is comprised of several
Technical Sections under the FDA's phased review of a NADA. The pivotal
effectiveness data described in this press release would be used to prepare
the submission of the Effectiveness Technical Section. The current
objective is to complete all the Technical Sections required for submission
of the administrative NADA to the FDA in approximately 12 months. The
Company intends to continue disclosing the current status of each Technical
Section in its periodic filings with the Securities and Exchange
By acquiring certain rights and patents in April 2000, ImmuCell began its
development of Mast Out®, which is an intramammary infusion product
containing Nisin for the treatment of subclinical mastitis in lactating
dairy cows. The dual purpose of such a subclinical treatment would be to
both clear the infection at an early stage and earn premiums for higher
quality milk (low Somatic Cell Counts). The use of antibiotics in
food-producing animals may be a contributing factor to the rising human
public health problem of bacterial drug resistance. As an alternative to
traditional antibiotics that are on the market, Mast Out® could
potentially reduce the use of traditional antibiotics in the treatment of
Preparations for this pivotal effectiveness study included the production
of registration batches of drug product to fulfill the pivotal regulatory
requirements of effectiveness, target animal safety, and stability at no
less than 10% of the scale anticipated for commercial manufacture. The
treatment phase of this study was initiated in June 2008.
Nisin, the same active ingredient contained in ImmuCell's product, Wipe
Out® Dairy Wipes, is an antibacterial peptide that is commonly used as a
preservative in dairy food products. Nisin is known to have activity
against most gram positive and some gram negative bacteria.
ImmuCell Corporation is a public, animal health biotechnology company
dedicated to developing, manufacturing and selling products that improve
animal health and productivity in the dairy and beef industries. Press
releases and other information about the Company are available at
Forward-Looking Statement Disclaimer:
The foregoing press release contains certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995,
such as, but not limited to, the likelihood of regulatory approval of Mast
Out® and certain label claims and our product development timeline.
Factors that could cause the Company's future results to differ materially
from those described in the forward-looking statements, together with other
risk factors, are detailed from time to time in filings we make with the
Securities and Exchange Commission, including our Annual Report on Form
10-K and our Quarterly Reports on Form 10-Q. Forward-looking statements in
this press release are based on our current information and expectations.
Actual results may differ materially due to various factors, including
Contact Information: Contact:
Michael F. Brigham
President and Chief Executive Officer
(207) 878-2770 Ext. 3106