DOYLESTOWN, Pa., Nov. 8 /PRNewswire-FirstCall/ -- The Quigley Corporation 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 (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(R) 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(R) 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.
CONTACT: Media Investor Relations Karen Pineman Carl Hymans G.S. Schwartz & Co. G.S. Schwartz & Co. 212.725.4500 212.725.4500 kpineman@schwartz.comcarlh@schwartz.com
The Quigley CorporationCONTACT: media, Karen Pineman, or kpineman@schwartz.com; or investors,Carl Hymans, carlh@schwartz.com, both of G.S. Schwartz & Co.,+1-212-725-4500, for The Quigley Corporation
