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®, 
      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® 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®, 
      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:
          
        
      
      
        
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          age - adults (particularly those age 40 and over)
        
      
      
        
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          tobacco use - particularly if combined with heavy alcohol consumption
        
      
      
        
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          heavy alcohol consumption
        
      
      
        
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          excessive sun exposure to the lips
        
      
      
        
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          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® 
      Plus with TBlue® (“ViziLite® 
      Plus”), the company’s 
      flagship product for the early detection of oral abnormalities that 
      could lead to cancer. ViziLite® 
      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® 
      Professional Powered Brush, the Pro-Select Platinum® 
      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.