• 10/6/2005
  • Philadelphia, PA
  • press release
  • Genetic Engineering News (www.genengnews.com)

Zila Pharmaceuticals, Inc., a business unit of Zila, Inc. will launch its ViziLite(R) Plus with TBlue630(TM) oral lesion identification and marking system at the 146th American Dental Association Annual Session in Philadelphia, October 6 to 9, 2005.

ViziLite(R) Plus combines the oral screening technology of ViziLite, an advanced chemiluminescent light technology to help detect oral abnormalities, with TBlue630, a marking system using Zila(R) Tolonium Chloride (ZTC(TM)), the only patented pharmaceutical-grade form of toluidine blue that has been cleared by the FDA for use in marking lesions identified during a ViziLite(R) examination. ViziLite(R) Plus makes oral screening more comprehensive than ever before and is indicated for use in individuals at increased risk of oral cancer: if ViziLite(R) reveals an abnormality, TBlue630 can then be used to mark suspicious lesions for further evaluation.

Douglas D. Burkett, Ph.D., Zila’s Chairman, President and CEO, stated, “The launch of ViziLite(R) Plus with TBlue630 is an important milestone in the fight against oral cancer. The use of Zila(R) Tolonium Chloride in this new system provides the practitioner with an opportunity to further evaluate and monitor lesions after they are identified during a ViziLite(R) examination. ViziLite(R) Plus helps dental professionals perform a complete and thorough oral screening, and we all recognize that better screening saves lives. We are pleased that with the recent addition of Sullivan-Schein Dental, all major dental distributors in the U.S. are now promoting ViziLite(R).”

Zila Pharmaceuticals will supply ViziLite(R) Plus in product configurations of twenty ViziLite(R) exam kits with two TBlue630 marking systems, and forty ViziLite(R) exam kits with four TBlue630 marking systems. A supplemental product configuration comprised primarily of TBlue630 marking systems will also be available to those that have previously purchased ViziLite(R) Plus. Shipping of ViziLite(R) Plus will begin on a limited basis after the ADA launch primarily to opinion leaders, with general distribution to follow shortly thereafter.

In addition to launching ViziLite(R) Plus with TBlue630 at the ADA annual meeting, several other important activities will take place. For the first time, ViziLite(R) will be included by the ADA as a part of the health screening service being provided to all dental professionals in attendance at the event. Free ViziLite(R) screening exams will be performed all day on Saturday, October 8, 2005 in the Philadelphia Marriott Hotel.

Zila Pharmaceuticals will also announce the details of an agreement with the ADA Foundation to fund programs to increase the awareness of oral cancer among the ADA membership in 2006 and beyond. In attendance at the announcement, scheduled for October 9 at the Philadelphia Marriott Hotel, will be Zila executives, ADA Foundation executives, and several members of the newly appointed Zila Dental Advisory Board.

The new Zila Dental Advisory Board is a group of dental professionals that will advise the company on issues related to advancing the message of oral screening in dentistry, to include consulting with the company on marketing and sales issues, and providing input on the design and implementation of clinical trials. The members of the Zila Dental Advisory Board are:

— David Sirois, DMD, Ph.D. from the New York University College of Dentistry;

— Joel Epstein, DDS, MSD, FRCD from the College of Medicine, Chicago Cancer Center;

— Sol Silverman, Jr., DDS, MS from University of California at San Francisco Comprehensive Cancer Center;

— Angelo Mariotti, DDS, Ph.D, from The Ohio State University College of Dentistry;

— Lawrence Meskin, DDS, Ph.D., from Colorado University School of Dentistry; and

— Jill Rethman, RDH, BA, Dental Consultant and Speaker from Kaneohe, Hawaii.

“We are pleased and honored to be working with these leaders in the field of dentistry as well as the ADA Foundation as we continue to grow our products and technologies to detect pre-cancer and cancer at the earliest possible stage in order to save lives,” stated Dr. Burkett.

About Oral Cancer:

According to the Oral Cancer Foundation, approximately 30,000 new oral cavity and pharyngeal cancers are being diagnosed each year in the U.S., resulting in the death of approximately 50% of the people affected within five years. Oral cancer remains one of the most debilitating and disfiguring of all malignancies. In most people diagnosed with oral cancer, the disease has metastasized, resulting in a poor prognosis because the usual method of detecting the disease is a visual examination that only results in the identification of early cancers 35% of the time. Those who do survive frequently undergo disfiguring surgery. When oral cancer is detected early, survival rates are about 80%; detected late, the survival rate reportedly falls to 20%.

About Zila Tolonium Chloride:

Zila(R) Tolonium Chloride (ZTC(TM)) is a patented composition of matter that is designed to be superior to traditional toluidine blue. ZTC(TM) is the ingredient in the recently FDA cleared TBlue630 and is also the active ingredient in OraTest(R) which is progressing through the regulatory process with the FDA.

Zila now has nine issued United States patents related to ZTC(TM) and/or the OraTest(R) product with expiration dates ranging from 2011 to 2020. An additional 34 corresponding foreign patents have been issued, including European patents covering 15 additional countries, and there are pending United States and international applications that would result in coverage of ZTC(TM) and/or OraTest(R) related technology by over 250 United States and foreign patents. These patents and pending applications cover: (i) the composition of matter for ZTC(TM); (ii) the process for manufacturing ZTC(TM); (iii) the mechanism of action, methods and products for using ZTC(TM) to detect epithelial cancer; (iv) utilizing ZTC(TM) or related technology to mark lesions identified by optimized wavelength light and (v) other compounds that are chemically related to Tolonium Chloride for use in detecting epithelial cancer.