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Monday November 9, 12:33 pm Eastern Time
Company Press Release
SOURCE: Zila, Inc.
FDA Accepts, Assigns Priority Review to
Zila's OraTest(R) New Drug Application
PHOENIX, Nov. 9 /PRNewswire/ -- Zila, Inc. (Nasdaq: ZILA - news), international provider of healthcare products
for dental/medical professionals and consumers, announced that the U.S. Food & Drug Administration (FDA) has
accepted the Company's New Drug Application (NDA) for the OraTest(R) oral cancer detection system. The FDA
has advised that the NDA is being given ''priority review,'' which targets completion of agency review within six
months from September 3, 1998, when the Company provided newly requested histopathology data. ''Priority
review'' is reserved for therapies that may substantially improve the standard of treatment for a certain disease or
condition.
Zila President Joseph Hines said, ''The effort to obtain marketing approval for our life-saving diagnostic adjunct
has taken much longer than any of us imagined. It is gratifying, however, that the end of the process is near. We
have said in the past that the FDA advised that OraTest would be fast-tracked once all the necessary data was filed
and accepted. That day has finally come.''
Dr. Ralph Green, President of Zila Biomedical, noted, ''In 1997, Zila began manufacturing a form of tolonium
chloride (OraTest's active ingredient, also referred to as toluidine blue) that is significantly purer than the material
originally submitted as a standard to the agency. At the FDA's request, Zila's in-house experts worked with several
research laboratories to validate a new purity standard. While this effort was expensive and time consuming, it
enabled Zila to file additional OraTest patent applications, further distinguishing OraTest as a unique and important
diagnostic adjunct.'' Green said the purity data, plus additional histopathology data requested in mid- summer 1998,
was included in the 22-volume NDA submission.
The FDI World Dental Federation recently endorsed toluidine blue (OraTest), for the detection and management of
oral cancer. The FDI is comprised of 130 national dental associations representing more than 600,000 member
dentists. The FDI also announced it will conduct a global education campaign on oral cancer in the year 2000, to
mark the organization's 100th anniversary.
OraTest is available or approved in 13 countries; additional regulatory approvals and distribution agreements are
being pursued worldwide. 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. A clinical study
undertaken pursuant to FDA Investigational New Drug (IND) regulations has shown OraTest to be 100 percent
sensitive for squamous cell carcinoma, the common form of oral cancer.
''Early detection is the key,'' said Dr. Green. ''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.''
In the U.S., oral cancer is more common than leukemia, skin melanoma, brain cancer, liver cancer, bone cancer,
thyroid cancer, stomach cancer, ovarian cancer and cervical cancer. Oral cancer kills twice as many people each
year as cervical cancer. In most of the underdeveloped world, oral cancer ranks third in mortality rate among all
cancer types. According to the American Cancer Society, the U.S. this year can expect 41,400 new oral,
nasopharyngeal and laryngeal cancers and 12,300 deaths. Worldwide, nearly 900,000 new cases of oral cancer
occurred in 1996; incidence and mortality rates are rising.
Oral cancer is more than twice as common in men as in women, and is most frequent in those age 40 and over. At
high risk are smokers and other tobacco users, consumers of alcoholic beverages, betel nut chewers, those with a
history of cancer and those who are immunocompromised. The odds of developing oral cancer increase with
frequency and duration of use of tobacco and alcohol, and with combined use of the two. With 25 million adult
American smokers visiting dentists at least once a year (according to data published in the Journal of the American
Dental Association), these healthcare professionals are in the front line of early detection of this serious disease.
To meet anticipated demand, Zila is expanding its Zila(R) Tolonium Chloride manufacturing facility in Phoenix with
the addition of a second production line. The Company will be able to produce enough material for 7.4 million
OraTest kits per year. Following FDA final approval, OraTest will be available in the U.S. exclusively through Zila
Dental Supply, the Company's national dental products distributor. Each single-patient test kit is expected to cost
healthcare professionals approximately $20.
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.
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