DOYLESTOWN, PA - January 24, 2005 - The Quigley Corporation (Nasdaq: QGLY),
the leading developer and marketer of diversified health products today
announced a research and development update for its wholly-owned Quigley Pharma
(Ethical Pharmaceuticals) subsidiary, which is developing natural-source
prescription medicinals for Influenza A, Radiation Dermatitis and Diabetic
Neuropathy.
According to Chief Operating Officer Dr. Richard Rosenbloom, "We continue to be
very pleased with the progress of our Pharma subsidiary. As we work through the
development and testing phases we become increasingly encouraged about the
possible efficacy of our products, and we continue to receive positive feedback
from the medical research community."
The financial strength of its parent corporation and the company's proven
success in launching first-in-category health solutions supports the Pharma
subsidiary in its efforts to develop groundbreaking formulations to combat a
variety of health issues.
The following is a list of formulations currently in the Quigley Pharma pipeline
and an update on their progress:
Influenza A -- QR-435: Retroscreen Ltd. at The University of London has started
a final animal model influenza study in preparation for a proposed human Proof
Of Concept Study to start in mid- 2005. The study "Prophylactic potential of
different QR-435 antiviral nasal spray formulations in the Influenza
A/Panama/2007/99 (H3N2) virus ferret transmission model" will determine if
there is any efficacy or safety issues with different dose forms of this
naturally derived broad-spectrum anti-viral compound.
Systemic Radiation -- QR-336: There were encouraging results seen in a
preliminary non-GLP animal study of this naturally derived radio protective
compound against ionizing radiation. A pre-IND meeting was held at the FDA in
October with the Division of Medical Imaging and Radiopharmaceutical Drug
Products. A GLP controlled animal study of the QR-336 formulation for the
Radioprotection/Treatment of Radiation Lethality Induced by Four MeV Photons in
the C3H Mouse will start this year, and predicated upon positive results will
be followed by a second animal study.
Diabetic Neuropathy -- QR-333: Per the FDA's instructions at the last Pre-IND
Meeting for the continued development of this drug; the compound is undergoing
a series of toxicity studies to support the safety of this naturally derived
compound for the relief of symptoms of diabetic peripheral neuropathy, prior to
beginning a human Phase IIB dose ranging study. The company expects the
toxicity studies to be completed in the 1st Quarter of 2005. The company hopes
to begin pivotal studies on this compound in 2005.
Virucidal Compound -- QR-437: Ongoing pre-clinical research activities include:
the completion of a second in vitro experiment to determine virucidal or
virustatic properties against the HIV virus by QR-437. The results of the first
in vitro study determined that this naturally derived compound has significant
dose dependant virucidal properties with a probable rapid mode of action. This
type of compound might be used with condoms or intravaginal, oral and other
topical dose forms as a first line defense against infection. Ongoing plans for
this compound are pending; the company expects to announce next steps some time
in 2005.
Quigley Pharma is also conducting research on their previously announced
patented compound for the treatment of rheumatoid arthritis and similar
diseases.
It has conducted one positive pre-clinical in vitro study on Avian Flu,
demonstrating antiviral activity when tested in a virustatic test. Ongoing
plans for this compound are pending; the company expects to announce next steps
some time in 2005.
About Quigley Pharma
The Quigley Corporation (Nasdaq: QGLY, http://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. In September of 2004, The Company has also formed a wholly owned
subsidiary, Quigley Manufacturing, Inc. with the acquisition of two FDA
approved facilities to manufacture its COLD- EEZE® branded lozenges.
InnerLight, Inc., a wholly owned subsidiary, was formed in January 2001 for the
purpose of introducing new products to the marketplace through a network of
independent distributors. 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 U.S. Food and Drug Administration
or any other regulatory agency will grant an IND or take any other action to
allow the aforementioned products 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.
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.
