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Datum nieuwsfeit: 28-10-2008
Zila krijgt toestemming voor onbeperkte marketing van OraTest in zeven Europese landen
( BW)(AZ-ZILA-INC)(ZILAD) Zila Receives Indefinite OraTest Marketing
Authorization in Seven European Countries
Business Editors/Health/Medical Writers
PHOENIX--(BUSINESS WIRE)--Oct. 28, 2008--Zila, Inc. (NASDAQ:ZILAD)
today announced that the U.K. Medicines and Healthcare products
Regulatory Agency (MHRA) has issued an indefinite renewal of the
marketing authorization for OraTest(R), the company's proprietary oral
cancer diagnostic kit. Under the European Union's (EU) mutual
recognition process, the company expects to receive renewal licenses
for member states including Finland, Greece, Luxembourg, The
Netherlands, Belgium, the U.K. and Portugal, over the next 30 to 60
days. The combined population of these seven countries exceeds 100
million. The company is seeking marketing partners in the seven EU
countries.
OraTest is indicated as an adjunct to visual examination in
patients considered at high risk for having high-grade premalignancies
or malignant lesions. The product can also be used to monitor patients
with previously treated oral squamous cell carcinoma for recurrent
disease. The kit contains Zila's patented, pharmaceutical grade
tolonium chloride rinse product.
"Adding OraTest to our international product portfolio provides
the opportunity to expand the potential market for our oral cancer
screening and testing product franchise," said David Bethune, Zila's
chairman and chief executive officer. "The OraTest diagnostic kit and
ViziLite(R) Plus, our proprietary oral cancer screening technology,
are complementary products with distinct indications, which will allow
us to market to a more diverse group of healthcare professionals
within the EU."
Pursuing regulatory approval in additional EU countries is under
evaluation. Since the initial approvals of OraTest in the EU, Zila has
compiled additional evidence-based data in support of approval.
Zila's proprietary oral cancer screening technology, ViziLite
Plus, utilizes a chemiluminescent light source (ViziLite) and the
patented vital tissue dye TBlue(R), helps dental professionals
identify and evaluate abnormalities in the mouth that could
potentially harbor pathologic changes. ViziLite Plus is for use in a
population at increased risk for oral cancer.
About Oral Cancer and OraTest
Oral cancer is the sixth leading cause of cancer worldwide, and in
the U.S., one person dies every hour from the disease. According to
American Cancer Society data, nearly as many women will be diagnosed
with oral cancer as with cervical cancer this year. The key to
reducing the impact of this disease is early detection. Some worldwide
clinical trials have demonstrated that the conventional visual/tactile
examination may fail to identify up to 40% of cancers and precancers.
Oral Cancer Risk factors:
-- age - adults (particularly those age 40 and over)
-- tobacco use - particularly if combined with heavy alcohol
consumption
-- heavy alcohol consumption
-- excessive sun exposure to the lips
-- sexually transmitted human papillomavirus (HPV)
About Zila, Inc.
Zila, Inc., headquartered in Phoenix, Arizona, is a diagnostic
company dedicated to the prevention, detection and treatment of oral
cancer and periodontal disease. Zila manufactures and markets
ViziLite(R) Plus with TBlue(R) ("ViziLite(R) Plus"), the company's
flagship product for the early detection of oral abnormalities that
could lead to cancer. ViziLite(R) Plus is an adjunctive medical device
cleared by the FDA for use in a population at increased risk for oral
cancer. In addition, Zila designs, manufactures and markets a suite of
proprietary products sold exclusively and directly to dental
professionals for periodontal disease, including the Rotadent(R)
Professional Powered Brush, the Pro-Select Platinum(R) ultrasonic
scaler and a portfolio of oral pharmaceutical products for both
in-office and home-care use. All of Zila's products are marketed and
sold in the United States and Canada primarily through the company's
direct field sales force and telemarketing organization. The company's
products are marketed and sold in other international markets through
the direct sales forces of third party distributors. Zila's marketing
programs reach most U.S. dental offices and include continuing
education seminars for dentists and their staffs.
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. These forward-looking
statements are based largely on Zila's expectations or forecasts of
future events, can be affected by inaccurate assumptions and are
subject to various business risks and known and unknown uncertainties,
a number of which are beyond the Company's control. Therefore, actual
results could differ materially from the forward-looking statements
contained herein. A wide variety of factors could cause or contribute
to such differences and could adversely affect revenue, profitability,
cash flows and capital needs. There can be no assurance that the
forward-looking statements contained in this press release will, in
fact, transpire or prove to be accurate. For a more detailed
description of these and other cautionary factors that may affect
Zila's future results, please refer to Zila's Form 10-K for its fiscal
year ended July 31, 2007 and Form 10-Q for the quarter ended April 30,
2008.
For more information about the company and its products, please
visit www.zila.com.
--30--CW/la*
CONTACT: Investors:
PondelWilkinson Inc.
Robert Jaffe, 310-279-5969
or
Media:
Sklar & Associates
Bill Sklar, 520-299-2830
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