DOYLESTOWN, PA (November 8, 2005) The Quigley Corporation (NASDAQ: QGLY),
announced today that its wholly owned subsidiary Quigley Pharma has received
three Investigational New Animal Drug (INAD) numbers from the Center for
Veterinary Medicine of the Food and Drug Administration. In a prior successful
series of in-vitro and ferret model in-vivo studies, the company's naturally
derived QR-441A formula has shown antiviral properties against the avian
influenza H5N1 virus. The company can now begin immediate testing of its
potential veterinary drug upon chickens, turkeys and ducks.
Quigley Pharma's COO, Dr. Richard Rosenbloom stated: "Since Quigley Pharma
is developing this formula primarily for human use, we feel it is important to
develop a veterinary version simultaneously. In this way we may be able to help
protect the food chain and its related industries."
QR-441A has the potential to inhibit infectivity of the avian H5N1 virus in a
poultry population. The FDA will be consulted under these INADs regarding
company generated protocols in order to expedite these studies and the steps
that will be required in order to get QR-441A approved as a veterinary drug. An
INAD is the equivalent to an IND (Investigational New Drug) for the human
ethical drug approval process.
Quigley Pharma will be working with government and private Biosafety Level 3
facilities in order to test QR-441A in these three species that are most
vulnerable to avian flu virus. Biosafety level 3 facilities are required in
order to work with live avian H5N1 virus. These labs are under strict
supervision by government agencies including CDC and USDA.
The Quigley Corporation is the leading developer and marketer of diversified
health products. The company's proven success in launching first-in-category
health solutions supports the Pharma subsidiary in its efforts to develop
strong pharmaceutical compounds targeting diverse conditions such as diabetes
and rheumatoid arthritis with naturally derived compounds and botanicals.
The Quigley Corporation makes no representation that the U.S. Food and Drug
Administration or any other regulatory agency will grant an IND for human study
or take any other action to allow the aforementioned compound to be marketed.
Furthermore, no claim is made that the potential medicine discussed here is
safe, effective, or approved by the Food and Drug Administration.
About The Quigley Corporation The Quigley Corporation
(Nasdaq: QGLY, http://www.Quigleyco.com) is a diversified natural health medical science
company. Its Cold Remedy segment is a leading marketer and manufacturer of the
COLD-EEZE® family of lozenges, gums and sugar free tablets clinically
proven to cut the common cold nearly in half. COLD-EEZE customers include
leading national wholesalers and distributors, as well as independent and chain
food, drug and mass merchandise stores and pharmacies. The Quigley Corporation
has four (4) wholly owned subsidiaries. Darius International markets health and
wellness products through its wholly owned subsidiary, InnerLight Inc. Quigley
Manufacturing Inc. consists of two FDA approved facilities to manufacture
COLD- EEZE® lozenges as well as fulfill other contract manufacturing
opportunities. Quigley Pharma Inc. (http://www.QuigleyPharma.com) conducts
research in order to develop and commercialize a pipeline of patented botanical
and naturally derived prescription drugs.
Certain statements in this press release are "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995 and involve known and unknown risk, uncertainties and other factors
that may cause the company's actual performance or achievements to be
materially different from the results, performance or achievements expressed or
implied by the forward-looking statement. Factors that impact such
forward-looking statements include, among others, changes in worldwide general
economic conditions, changes in interest rates, government regulations, and
worldwide competition.
