Quigley Pharma Inc. Evaluates Regulatory and Market Opportunities for Anti-Inflammatory / Cytokine Modifying Compound
DOYLESTOWN, Pa., August 1 /PRNewswire-FirstCall/ -- Quigley Pharma, www.QuigleyPharma.com, a wholly owned subsidiary of The Quigley Corporation announced today that based on ongoing data analyses from past and current studies on it's botanical formulation identified for use as, QR440 for Arthritis, QR443 for Cachexia and QR449 for Metabolic Syndrome; it is assessing alternative regulatory and marketing strategies, in addition to prescription, such as a medical food or nutritional supplement, where a product could be readily accessible to physicians and patients much sooner without the usual regulatory challenges. The goal of this strategy is not only to optimize and preserve patient and product value while adhering to recognized regulatory and product substantiation methods but also to bring to the marketplace products that have an immediate medical need within a more expeditious time frame than prescription drugs.
Although the Company is reserving its right to pursue other options, with the recent announcement of its QR-449 first in human safety trial in Metabolic Syndrome patients (announced July 30, 2007), it has initiated steps toward developing a product as a medical food, which would allow direct promotion to physicians and require administration under the supervision of a physician.
As a medical food the marketing and use of the product would be supported by a GRAS (Generally Regarded as Safe) statement as well as human safety and efficacy clinical studies that show the product aids in the metabolic management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Development under the medical food strategy differs from a prescription drug by not requiring FDA, IND and NDA approvals. Claims as a medical food are limited to management of disease via correction of metabolic imbalances and restoration of homeostasis.
The Company has sought and gained expert legal and scientific advice and acknowledgement that adherence to the current strategy and development approach would meet the requirements as defined by the FDA guidance for medical foods.
The Company has been utilizing the QR-440, 443 and 449 nomenclatures to reference a single formulation which has been shown to modify pro-inflammatory cytokines which are present in the different possible indications of use, QR440 for Arthritis, QR443 for Cachexia and QR449 for Metabolic Syndrome. It is the cytokine modification activity and its possible effects on clinical laboratory and nutrient parameters, that is leading the Company to investigate the potential for developing the product as a medical food for these chronic inflammatory diseases.
Dr. Richard Rosenbloom, Exec VP COO of Quigley Pharma commented; "Medical foods have the potential to be a safe cost effective adjunct to traditional drug therapy for metabolic syndrome and other chronic inflammatory diseases."
About Medical Foods:
Defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) and 21 C.F.R. section 101.9(j)(8). For "Frequently Asked Questions About Medical Foods" see: http://www.cfsan.fda.gov/~dms/medfguid.html
The Quigley Corporation makes no representation that if this product is a prescription drug or medical food the US Food and Drug Administration or any other regulatory agency will allow this product to be marketed. Furthermore, no claim is made that potential medicine discussed herein 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 several 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.
Forward-Looking Statements
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
Quigley PharmaCONTACT: Media, Karen Pineman, +1-212-725-4500, kpineman@schwartz.com, orInvestor Relations, Carl Hymans, +1-212-725-4500, carlh@schwartz.com, bothof G.S. Schwartz & Co. for Quigley Pharma