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Drug tested for oral cancer detection
Zila shares could double if OraTest is approved, analysts say.
December 21, 2005: 3:27 PM EST
By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) - Oral cancer is a disfiguring affliction that is difficult to detect in its early stages, which is how it manages to kill half the people it infects.

"We are subduing the dangers of breast and cervical cancers in women, but we are doing nothing for one of the most insidious and heart-rending types of cancers, and that's oral cancer," said Marc Robins, founder of The Robins Group, an institutional brokerage firm.

Zila, Inc., an Arizona biotech, began late-stage testing on OraTest, its detection drug for oral cancer, earlier this month. If clinical trials for the drug are successful and if it's approved by the Food and Drug Administration, the company's stock could jump dramatically, analysts say. Zila has a similar product on the market ViziLite, that is considered a precursor to OraTest.

"Oral cancer is the dirty little secret of American health, and OraTest and ViziLite are the forefront for better health in this arena," said Robins.

The American Dental Association says nearly 30,000 Americans are diagnosed with oral cancer every year. Oral cancer is caused primarily by heavy drinking and smoking, though non-smokers and teetotalers represent one-fourth of all patients. Survivors sometimes have parts of their faces and tongues removed or reconstructed.

For decades, dentists have detected oral cancer by visually examining their patients' mouths. But by the time oral cancer forms visible spots or lesions, the cancer is already in its advanced stages.

OraTest, also known as tolonium chloride, is produced in the form of "an intense blue dye" that highlights cancerous tissue, according to Zila CEO Doug Burkett. The drug is designed to show early signs of mouth cancer that would not be visible to the naked eye. This would alert dentists to the disease at early stages, when the patient has a better chance of seeking treatment to avoid horrible facial deformities and death.

"Here you've got a disease that's three times as prevalent as cervical cancer," said Burkett, referring to oral cancer. "We're looking to screen high-risk individuals. These individuals who drink or smoke are high risk and should have the test at least once annually."

Zila has a similar product on the market, ViziLite, but the dye highlights a wide range of oral lesions, not just cancer, while OraTest specifically highlights cancerous tissue.

Analysts do not consider OraTest to be a potential blockbuster. Robins projects $100 million in OraTest annual sales and Block projects $300 million to $400 million. But analysts said sales in the hundreds of millions would go a long way for the small biotech, resulting in dramatic projections for Zila stock.

Zila (up $0.10 to $3.81, Research), based in Phoenix, was trading below $4 a share on Wednesday and the volatile stock has lost more than 10 percent of its value over the last 12 months. If OraTest is approved, the stock price could shoot up to $8.50 a share, more than double its current value, said Block, who rates the company a "strong buy." Robins, who also rates the company a "strong buy," anticipates that OraTest will enter the market in 2006 and has given Zila a 12-month price target of $7, nearly double its current price.

In a gesture of financial faith, Burkett said on Dec. 13 that he's committing one-tenth of his 2006 net income to buying Zila shares. That same day, the company announced its completion of phase 2 studies and its commencement of phase 3, the most advanced phase prior to regulatory review.

But biotechs are considered a risky business. If OraTest fails to impress, as it failed FDA review in 1999, analysts insist that Zila will survive based on sales of its "nutraceutical" dietary supplements Ester-C and Ester-E, produced by its non-biotech division. Sales for these products total about $40 million in 2005.

"If they don't get OraTest, you don't have a bankrupt company; you have a company that's financially viable," said Robins.

Robins owns shares of Zila stock, but Block does not own shares in the company.

To see how the biotechs performed in 2005 and projections for 2006, click here.  Top of page

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