Dual uses for impotence drug?

New evidence that impotence drug Cialis can also relieve symptoms of enlarged prostates could improve the drug's appeal in the global market to enhance the sex lives of older men.

Clinical-trial data released yesterday showed that Cialis, produced by Lilly Icos, the joint venture of Bothell biotech Icos and pharmaceutical giant Eli Lilly, was an effective treatment for symptoms of benign prostatic hyperplasia (BPH), a condition found in more than half of men over 50.

Men who took 5 milligrams of tadalafil — the generic name for Cialis — daily for six weeks had an average 2.8-point improvement in their score on a questionnaire that assessed the severity of BPH symptoms, which include a range of problems urinating.

Men who took a placebo saw their score improve 1.2 points.

When the dose was increased 20 milligrams a day, men taking the drug averaged a 3.8-point improvement, compared to a 1.7-point improvement for the placebo group.

Icos shares closed up 4.26 percent at $26.46 yesterday after trading as high as $28.56 earlier in the day.

The company sees tadalafil as a potential competitor in the $2.5 billion BPH market.

There's also a large overlap of men who have both enlarged prostates and erectile dysfunction.

"The thought of having one pill that would take care of both would be very appealing," said Dr. Fred Govier, head of urology at Virginia Mason Medical Center in Seattle and a member of Icos' physician advisory boards.

By offering a treatment for both conditions, the company could gain an edge over erectile-dysfunction drugs such as Viagra and drugs that solely treat BPH, such as Flomax, which had sales of about $1.2 billion last year.

Some analysts have questioned whether tadalafil will be as effective as Flomax in treating BPH, said Paul Latta, who covers biotech companies for Adams Wright Ragen in Seattle.

"But Flomax won't improve your sex life, so [tadalafil] will still be a meaningful seller in that market," Latta said.

In fact, many BPH treatments currently on the market carry side effects including decreased libido and erectile dysfunction.

Tadalafil's side effects in the recently completed Phase II trial were indigestion, back pain and headache, none of which was reported by more than 5 percent of the 250 men in the study.

Approval of tadalafil for treatment of BPH could also expand the erectile-dysfunction market. In a recent survey conducted for Lilly Icos, 25 percent of men said they were "somewhat" or "not at all" likely to talk with their doctors about erectile dysfunction.

"It would be logical to think a lot more men would be willing to ask for treatment for [enlarged prostate] than erectile dysfunction," said Chris Raymond, biotech analyst with Robert W. Baird & Co.

With the cost of developing a single new drug in the hundreds of millions, Icos sees "a tremendous advantage" in expanding the use of a product that's already on the market, said Chief Medical Officer Dr. David Goodkin.

Lilly Icos plans a Phase 3 trial of tadalafil, though it did not say when that would begin. Latta said the earliest the drug could be on the market for treatment of BPH is late 2007.

The company is also studying the effects of tadalafil on patients with pulmonary arterial hypertension and high blood pressure.

Benjamin J. Romano: 206-464-2149