Zila Receives Indefinite OraTest Marketing Authorization in Seven European Countries
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.