Gel gives aging males an edge

The success of Viagra has opened the door to products such as the testosterone gel.
PHILADELPHIA (AP) -- Founders of a 3-year-old pharmaceutical company hope that for aging baby boomers, the Fountain of Youth will come in a tube.
Auxilium Pharmaceuticals Inc.'s first product is a gel called Testim, sold in small one-dose tubes and prescribed for men with low testosterone levels.
Patients rub it on their arms and shoulders to restore normal levels of the hormone and combat the sagging sex drive, low energy, depression and dwindling muscle mass and bone density a deficiency can cause.
The market for testosterone replacement therapies is growing fast as the population of older men increases.
Timing
"We are fortunate timing-wise, because men have taken a much more active role in the management of their own health," said Gerri Henwood, president and chief executive of Auxilium.
That's partly because they're aging, and partly sparked by Pfizer's introduction of the erectile dysfunction drug Viagra, with its five years of promotions featuring Bob Dole, race car driver Mark Martin and other celebrities.
"Viagra has had a role in that there are areas that are much more open for discussion between men and their physicians," Henwood said.
Henwood and Jane Hollingsworth, a vice president in a clinical trials company Henwood had previously launched, founded Auxilium shortly after that company was sold in 1998.
"Jane and I started brainstorming about where were there therapeutic opportunities for small companies to enter the market," Henwood said.
They settled on products to help people continue to function normally as they age. Auxilium is Latin for "assistance."
Following the lead
Testim is only the second testosterone gel to get Food and Drug Administration approval.
IMS Health, which tracks prescription drug sales, has said the market for testosterone products in general jumped from $49 million in 1997 to $216 million last year.
The first testosterone gel on the market, Androgel, launched by the Belgian pharmaceutical company Solvay S.A. in 2000, posted about $196 million in U.S. sales last year, a 52 percent jump from 2001.
"We should be able to emulate Androgel's early years," Henwood said.
Testosterone treatments are in the spotlight, said Dr. Alvin M. Matsumoto, a gerontologist at the University of Washington and the Veterans Administration Puget Sound Health Care System in Seattle.
"The market is growing fast, and it's primarily because a gel is available," Matsumoto said.
Testosterone replacement therapy has been done for years using injections, but levels can fluctuate from above normal just after the shot to below normal before the next shot about two weeks later.
Some patients don't feel the roller coaster effect, but others run out of energy before the next injection, Matsumoto said.
Testosterone patches also have been used but tend to result in lower levels of the hormone and sometimes can cause rashes and skin irritation, he said.
Testosterone levels normally decline gradually in men over 30, and researchers are looking at whether testosterone replacement should be used only for those with levels far below normal, who experience severe symptoms, or should be given to counteract the normal decline.
Concern
That became a focus since a report last year that hormone replacement therapy frequently prescribed for women actually increased the risk of heart attacks, strokes and breast cancer, leading most doctors to recommend it only for short-term treatment of menopausal symptoms.
"There are very analogous questions about hormone replacement therapy in men that need to be addressed as well," said Matsumoto, who has pushed for large-scale clinical trials of testosterone replacement in men. "They need to be addressed sooner rather than later because there is so much testosterone being prescribed now."
Henwood said there is a large market regardless. An estimated 5 million men in America have lower than normal testosterone levels, she said.
With the growing population of aging males, Henwood said, "We think over time the product can certainly be in the hundreds of millions."
Auxilium is privately held, and Henwood wouldn't give more specific figures, but she said the testosterone gel market is just the kind of niche Auxilium's founders were looking for.
"Below half a billion to $1 billion, it is not worth it for large pharmaceutical companies to enter, and that creates opportunities for little guys like us," she said.