DOYLESTOWN, Pa., Dec. 6 /PRNewswire-FirstCall/ -- The Quigley Corporation announced today that its wholly owned subsidiary Quigley Pharma received an Investigational New Animal Drug (INAD) number from the Center for Veterinary Medicine of the Food and Drug Administration, and can now begin immediate testing of its naturally derived QR-441A formula for Avian Flu on pigs. This is the eighth and final INAD species that the company has applied for and received, firmly establishing the company's veterinary commitment in parallel to the human drug development program.
Dr. Richard Rosenbloom, Quigley Pharma's Chief Operations Officer stated: "This is a very important INAD, as pigs have been implicated in the emergence of new influenza viruses responsible for two of the century's influenza pandemics."
Dr. Rosenbloom noted that avian influenza has already been detected in pigs in several Asian countries, as far back as early 2004. As the avian influenza virus continues to circulate in poultry stocks of many countries throughout the world, the swine-avian influenza virus becomes a much larger threat. Pigs may carry the human influenza virus, which may combine through genetic reassortment with the avian virus, further adding to infection potential for humans. Dr. Rosenbloom added, "Quigley's QR-441(a) has the potential of not only protecting pigs from swine-avian influenza virus, but also may help reduce the chance of mutation to a form of avian virus that would cross into humans. This could be of significant benefit in controlling the possibility of a human pandemic stemming from poultry to swine infectivity, which is very likely due to the proximity of these two farm food species."
In a prior successful series of in-vitro and ferret model in-vivo studies, conducted under the direction of Professor John Oxford, Dr. Rob Lambkin and Sebastien Bossuyt at Retroscreen Virology, Queen Mary's School of Medicine & Dentistry, University of London, UK, the formula has shown antiviral properties against the avian influenza H5N1 virus.
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 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.
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 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, kpineman@schwartz.com, or Investors, CarlHymans, carlh@schwartz.com, both of G.S. Schwartz & Co., +1-212-725-4500
Web site: http://www.quigleyco.com/
