DOYLESTOWN, PA. - March 29, 2004 - The Quigley Corporation (Nasdaq: QGLY)
announced today that Quigley Pharma completed their first meeting at the United
States Food and Drug Administration (FDA) prior to submitting the company's
Investigational New Drug (IND) application, for its compound QR-333 For the
relief of symptoms of diabetic symmetrical peripheral neuropathy. The FDA's
pre-IND meeting programs are designed to provide sponsors with advance guidance
and input on drug development programs.
Richard Rosenbloom M.D., Chief Operating Officer of Quigley Pharma Inc.,
stated, "Quigley Pharma received guidance from the FDA's Division of
Anesthetic, Critical Care and Addiction Drug Products, on the next steps
towards submitting the IND application for QR-333. This guidance will aid the
QR-333 program from the pending IND submission through to the pivotal phase III
program required for approval."
Diabetes afflicts 15. 7 million people in the United States, according to data
compiled from 1995-1998 by the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK). According to the NIDDK, the data also found that 60 to
70 percent of diabetics suffer mild to severe forms of nervous system damage
and resultant pain, a condition known as diabetic peripheral neuropathy.
About the Quigley Corportation
The Quigley Corporation (Nasdaq: QGLY), www.Quigleyco.com., is a leading
developer and marketer of diversified health products including the
Cold-Eeze® family of patented zinc gluconate glycine (ZIGG™) lozenges
and sugar free tablets. Cold-Eeze is the only (ZIGG™) lozenge proven in
two double-blind studies to reduce the duration of the common cold from 7.6 to
4.4 days or by 42%. In addition to Over-The-Counter (OTC) products, the company
has formed Quigley Pharma Inc. (http://www.QuigleyPharma.com ), a wholly owned
ethical pharmaceutical subsidiary, to introduce a line of naturally-derived
patented prescription drugs. The Quigley Corporation's customers include
leading national wholesalers and distributors, as well as independent and chain
food, drug and mass merchandise stores and pharmacies.
The Quigley Corporation makes no representation that the FDA will allow trials
under the IND to take place, or take any other action to allow the compound to
be studied or marketed. Furthermore, no claim is made that the potential
medicine discussed here is safe, effective, or approved by the Food and Drug
Administration. Safety and effectiveness in humans has to be demonstrated by
means of adequate and well-controlled clinical studies before the clinical
significance of a formula test compound is known.
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.
