Sensitive teeth, promising product USBiomaterials ready to talk with distributors pending FDA approval

January 30, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

USBiomaterials, a White Marsh-based biotechnology company that makes implantable medical products, said yesterday that it has developed a promising material that could help the millions of people who suffer from hypersensitive teeth and plans to seek approval to market the product in the United States by next year.

James L. Meyers, president of privately held USBiomaterials, said the company expects to be in discussions by the end of this week with major medical supplies and cosmetic products companies about a licensing agreement to distribute and market the as-yet-to-be named dental material, should it be approved by the U.S. Food and Drug Administration.

The company hopes to launch human clinical trials within three months and to present that data to the FDA by early next year, said Dr. David Greenspan, a co-developer of the material and vice president and chief technology officer at USBiomaterials.

If USBiomaterials is able to commercialize the material, it would represent the first time that the company's research alliance with the University of Maryland at Baltimore has paid off. The material was co-developed by Dr. Leonard Litkowski and Dr. Gary Hack, dentistry researchers at UMAB.

Should the company gain FDA approval for the product, Mr. Myers said, it would almost certainly emerge as the company's largest revenue generator.

"We really believe this is a quantum leap over the products available in the market now," said Mr. Myers.

A key revenue stream for the company, which recorded 1994 sales of $1.3 million, now comes from a strategic alliance with publicly held Block Drug Co. of Jersey City, N.J., a niche marketer to dentistry. Block sells its Perioglass product, used to fill bone defects that result from periodontal disease. Block also plans to market in 1997 USBiomaterials' Ermi product, which prevents the jawbone from sagging after tooth extraction.

Mr. Myers said Block has estimated the market for over-the-counter products to soothe the pain from hypersensitivity at $220 million worldwide, with the largest single market being the United States.

The market has been dominated for years by Sensidine, a toothpaste sold by Block that enjoys a 68 percent market share. An estimated 40 million people in the United States suffer from some form of tooth hypersensitivity.

Mr. Meyers sees one demographic factor in the firm's advantage should it gain FDA approval for the new material: The aging of the Baby Boom generation, aged 34 to 50.

"We're looking at a growing market for this product," he said.

Tooth, or dentin, hypersensitivity is most commonly seen in older people, said Dr. Bill Cohn, deputy clinical director at the Institute for Dental Research at the National Institutes of Health.

It occurs, he said, when the teeth's mineral coating is worn down over time by the chewing action and other factors, or by exposure of the gums.

The condition, Dr. Cohn said, is estimated to afflict 10 to 20 percent of the general population.

Laboratory tests showed that the new product helped restore the natural mineral coating of teeth, the company said.

It would most likely be marketed as a toothpaste additive or rinsing solution, Dr. Greenspan said.

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