November 30, 2004

VA.-Based Drug Firm Sees Hope for Gels ; They Put Less Strain on Digestive Systems Than Pills, Ascend Says

Herndon biopharmaceutical company Ascend Therapeutics is banking that more people with chronic diseases will want to take prescriptions through a quickly evaporating gel instead of by swallowing pills.

The drug-development company, formed in early 2002, has based its product line on gels that treat chronic conditions.

The gels, which are applied directly to trouble spots, put less strain on a patient's digestive system, said Ascend President and Chief Executive Jay Bua.

The company's front-line product, a breast-pain medication dubbed TamoGel, has finished its second clinical trial phase, an essential step before seeking market approval.

Ascend has one other product in the early development stage, a testosterone-replacement gel for men called Andrin, which is designed to prevent prostate growth.

Bua said the test results for TamoGel were positive.

In the trial, 120 women with varying breast-pain conditions applied the clear, liquid-based gel for four months. Most showed marked improvement with their conditions, he said.

Breast pain is a common problem for women younger than 50, although only a small number of women have pain severe enough to affect their daily routines.

Most doctors generally prescribe anti-inflammatory drugs, such as ibuprofin, for breast pain and encourage patients to wear better- supporting bras and use heating pads.

Dr. Michael Fleming, a family physician in Shreveport, La., said he knows of only one drug for breast pain, an androgen pill called Danazol.

"But it has a fair number of side effects and is fairly expensive," he said. "There really isn't anything for breast pain because we don't know what causes it."

He would not say how much demand there would be for a product like TamoGel.

Breast pain has been linked with a woman's menstrual cycle and hormonal imbalances, but there are no conclusive causes for the problem, said Fleming, chairman of the American Academy of Family Physicians.

Studies have shown that as many as 70 percent of American women experience breast pain, with 11 percent of those women having moderate to severe breast pain for more than five days a month, according to the Mayo Clinic's Breast Diagnostic Center in Rochester, Minn.

Bua said the potential market is about 11 million women each year who experience severe breast pain.

TamoGel is a formulation of a metabolite from the drug tamoxifen. It works as an "anti-estrogen," keeping estrogen receptors inside a woman's breast from acting irregularly, Bua said.

Bua said he is not aware of any other companies that are working on a competitor for TamoGel, adding that no gel for breast pain is on the market.

TamoGel is 70 percent complete for its Food and Drug Administration registration, he said. The third and last trial phase for the gel, which will involve 1,000 to 1,500 participants, is expected to begin in late spring and will take two years to complete.

Ascend then plans to submit TamoGel for market approval from the FDA by 2007, with arrival in the market by 2008.

With the trial progress, Ascend has more than doubled its staff and office space in the past year, from six to 14 employees. Bua said the company will hire an additional 11 to 16 employees next year.

The company is privately funded by a European investor group, which Bua said wishes to remain anonymous. The group invested $19 million for Ascend's operations so far.