- PR Newswire
Zila Professional Pharmaceuticals, a division of Zila, Inc. (Nasdaq: ZILA), announced the acquisition of world marketing rights (excluding the Pacific Rim) for the ViziLite(TM) chemiluminescent light technology, which is cleared by the U.S. Food & Drug Administration (FDA) for marketing in the United States. Using the ViziLite Test Kit in combination with a conventional visual oral mucosal examination, healthcare providers can improve the identification, evaluation and monitoring of oral mucosal abnormalities in those at increased risk for oral cancer. The American Cancer Society publication “Cancer Facts & Figures 2001” advises that the risk factors for oral cancer are cigarette, cigar or pipe smoking; use of smokeless tobacco; and excessive consumption of alcohol. Some 25 percent of oral cancer occurs in people with no known risk factors.
The transaction with Trylon Corporation of Torrance, California, involves up to 2,000,000 shares of restricted Zila common stock plus royalties (10 percent in the first five years, and 5 percent in the next five years) on ViziLite product sales.
Trylon continues to market a similar technology, the PapSure(R) screening test, for cervical health. That technology received FDA clearance based on a 13,000-patient clinical study involving 55 sites. Subsequently, in November 2001, the FDA granted clearance for oral application of the ViziLite Test Kit based on evidence of substantial equivalence as demonstrated by testing at the University of California/San Francisco and the University of the Pacific.
Dr. Ralph Green, Vice President and General Manager of Zila Professional Pharmaceuticals, noted, “Zila is pleased to bring this important device to market, even as the Company continues to support a Phase III clinical trial for its patented OraTest(R) oral cancer detection product. In those countries where both products are available, the two technologies are expected to be used in a complementary fashion. The acquisition and marketing of the ViziLite device furthers Zila’s objective of becoming the leader in oral soft tissue management.”
Dr. Green said the patented single-use ViziLite Test Kit will be distributed to U.S. and Canadian dentists exclusively by Patterson Dental Supply, Inc., with an expected U.S. marketing launch at the Chicago Midwinter Dental Meeting, February 22-24, 2002. The product will sell for approximately US$15. Zila intends to develop other international markets for the product, among both dentists and physicians.
Patterson Dental Supply, a subsidiary of Patterson Dental Company (Nasdaq: PDCO), provides a virtually complete range of consumable dental products, clinical and laboratory equipment, and value-added services to dentists, dental laboratories, institutions and other healthcare providers throughout North America. Patterson Dental Supply has the largest direct sales force in the industry, totaling over 1,100 sales representatives and equipment software specialists serving the United States and Canada.
The specific ViziLite wavelengths are absorbed by normal cells and reflected by abnormal cells (due to their higher nucleus-to-cytoplasm ratio). As a result, atypical or dysplastic mucosal abnormalities appear bright white, focusing the health professional’s attention on lesions which might not be seen otherwise and which may be revealed upon biopsy to include cancer and pre-cancer. Lesions identified with the ViziLite product can be monitored, biopsied, treated, or excised, according to the clinician’s judgment. ViziLite is used in conjunction with a traditional head and neck exam.
Prior to examination with the ViziLite device, the patient rinses with a 1% acetic acid solution; this disrupts the glycoprotein barrier of mucosal surfaces, improving visualization of abnormal tissue. The acetic rinse will be produced by Zila Technical Operations, and packaged with the device.