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Quigley Corporation Announces Final Results of Quigley Pharma's Phase IIb Study
Date:7/22/2009

iminary analysis of the lack of adequate primary and secondary end point data indicates that the results may have been attributed to fewer then expected evaluable patients due to a shortage of drug and a high number of patients terminated early due to a lack of compliance with application and usage protocols.

"We have recently hired an independent consultant to conduct a thorough review of the entire research and development portfolio of potential products in the Quigley Pharma pipeline," said Ted Karkus, CEO. "We will wait for this review to be completed before determining the next steps in the development of QR-333 and other formulations."

All required end of study regulatory and reporting documentation and procedures will be completed. Consistent with previous announcements and pending the full review of the product portfolio, the Company will continue to consider licensing, partnering or collaborative relationship opportunities to further the development and potential commercialization of the QR-333 candidate and other formulations.

The ADA estimates that neuropathy occurs in up to 60-70% of diabetics, and an estimated 5 million Americans are affected by diabetic peripheral neuropathic pain. The World Health Organization estimates that more than 171 million people have diabetes worldwide, a figure that is expected to rise to 366 million by 2030.

About the study:

Methodology:

This was a double-blind, randomized, parallel-group, placebo controlled study conducted at 22 sites with 1 to 27 patients randomized per site. Patients between the ages of 18 and 70 years with a diagnosis of diabetes and symptoms of peripheral neuropathy were eligible for enrollment into the study. Eligible patients were randomized to 1 of 2 groups each applying study cream topically to the feet three times daily (tid) with placebo or QR-333 for
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SOURCE Quigley Corporation
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