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To: brent gephart who wrote (21576)12/3/1998 2:53:00 PM
From: Scott A. Trapp  Read Replies (2) | Respond to of 119973
 
Zila's OraTest Scheduled For FDA Committee Review


December 3, 1998 02:09 PM
PHOENIX, Dec. 3 /PRNewswire/ -- Zila, Inc. ZILA , international provider of healthcare products for dental/medical professionals and consumers, announced that the U.S. Food & Drug Administration's Oncologic Drugs Advisory Committee will review Zila's New Drug Application for its oral cancer detection system, OraTest(R), at a hearing at 1:00 p.m., January 13, 1999, at the Gaithersburg (Maryland) Holiday Inn.
Zila reported earlier that the FDA accepted the OraTest NDA on September 3, 1998, and assigned it "priority review" status, which targets completion of agency review within six months. "Priority review" is reserved for therapies that may substantially improve the standard of treatment for a certain disease or condition.

Dr. Ralph Green, President of Zila Biomedical, said, "We are pleased that the FDA's OraTest review process is moving this rapidly, and we expect the committee will recommend approval of our inexpensive and potentially life- saving technology."

OraTest is a patented 5-minute mouthrinse sequence, used by dentists and physicians to detect early-stage, asymptomatic lesions and to define margins of lesions for biopsy and surgery. When oral cancer is detected at advanced stage, which occurs in the majority of cases today, 5-year survival rates are as low as 18 percent. But with early detection, survival rates exceed 90 percent. OraTest is available or approved in 13 countries; additional regulatory approvals and distribution agreements are being pursued worldwide.

Zila, Inc., markets pharmaceutical, biomedical, dental and nutritional products to professionals and consumers through seven divisions: Zila Biomedical is introducing the OraTest(R) oral cancer detection system worldwide; Zila Manufacturing produces the only pharmaceutical-grade toluidine blue - Zila(R) Tolonium Chloride; Zila Pharmaceuticals markets prescription and non-prescription oral healthcare products; Zila Dental Supply is a national dental supplies distributor; PracticeWorks develops and markets proprietary dental practice management software; Cygnus Imaging manufactures and markets intraoral video camera and digital x-ray systems; and Oxycal Laboratories manufactures and supplies Ester-C(R) vitamin products worldwide. More information is available at www.zila.com.

This document contains forward-looking statements which are based on Zila's expectations and are subject to various business risks and uncertainties, some of which are beyond Zila's control. Actual results could differ materially from these forward-looking statements as a result of such risks. There can be no assurances that the forward looking statements contained herein will in fact transpire or prove to be accurate.

SOURCE Zila, Inc