Viagra Shows Promise as Lung Therapy

NY Times ^ | October 28, 2004 | ANDREW POLLACK

[neverdem]

Viagra, which treats a common but decidedly nonfatal male malady, might soon have a new role treating a rare but life-threatening disease that strikes mainly women.

Doctors said yesterday that sildenafil citrate, the ingredient in Pfizer's impotence pill, had proven effective in a clinical trial as a treatment for pulmonary arterial hypertension - extremely high pressure in the artery carrying blood to the lungs.

"It is a very promising new therapy for the treatment of a very severe disease," said H. Ardeschir Ghofrani, an assistant professor at the University of Giessen in Germany, who presented the results at the annual meeting of the American College of Chest Physicians in Seattle yesterday.

The disease, which affects an estimated 100,000 people in the United States and Europe, can leave people breathless after even a routine household chore or a short walk.

A Pfizer spokesman, Daniel J. Watts, said the company was in discussions with regulators in the United States and Europe about whether the drug could be approved for the new use. However, he would not say when, or whether, Pfizer plans to seek approval.

Pfizer has said that it would sell the drug for the pulmonary disease in a different form from the blue Viagra pill and under a different name, to avoid mistaken prescriptions. Such a strategy might also allow Pfizer to charge more for the lung disease drug than for Viagra.

Asked about reports that Pfizer had already chosen the name Rovitio, Mr. Watts said: "I have heard that name. It's not official yet."

Viagra, with sales of $1.9 billion last year, is under competitive attack from new impotence pills.

Using Viagra for pulmonary hypertension, because of the small patient population, is not likely to add much to its sales. But Pfizer has acknowledged it might get a patent extension for Viagra because it is testing the drug in children, something it can do for pulmonary hypertension but not for erectile dysfunction.

There are already three drugs approved for pulmonary hypertension, but two require the drug to be pumped into the body around the clock. The only pill, Tracleer from the Swiss company Actelion, costs about $35,000 a year and users must be monitored for liver damage. Pfizer's drug, if sold at the same price as Viagra, would cost about $10,000 a year. In the trial, the drug showed no sign of liver toxicity or other serious side effects, said Dr. Ghofrani, who is a consultant to Pfizer.

The clinical trial reported yesterday involved 278 patients randomized to receive one of three doses of sildenafil or a placebo three times a day. After 12 weeks, those who had received the drug could walk 45 to 50 meters farther in six minutes than those who got the placebo. The six-minute walking test is a standard used in trials for pulmonary hypertension. The drug also reduced pressure in the artery feeding the lungs.

The presentation of the results attracted a huge crowd at the Seattle conference, in part because Pfizer's entry could hurt other companies like Actelion or several biotechnology companies also developing drugs for the disease, including Encysive Pharmaceuticals, Myogen and CoTherix.

"It was really chaos, actually," said Richard Channick, an associate professor at the University of California, San Diego, who was an investigator in the trial. "They were filling the room and had to open another room to accommodate people, many of whom appeared to me to be pharmaceutical industry people or investment analysts."

Indeed, stocks of some competitors dipped earlier this week on rumors that the Viagra results would be very strong. But those stocks rose yesterday after the verdict seemed to be that the Viagra results were not that different from those of the other drugs.

"I wouldn't call it a breakthrough, no," said Dr. Channick, who is a consultant to Actelion.

Shares of Pfizer rose 71 cents, to $29.04.

Bruce D. Given, chief executive of Encysive, whose drug is in the final stage of clinical trials, called the Viagra results "good enough to bring Pfizer into the game with their marketing muscle," but "not good enough to sink the rest of the products." He said it was likely that drugs that work by different mechanisms would be used in combination.

[Chieftain]

Looks like it helped these lungs... LOL!!

[mad_as_he$$]

I have four jokes already and I can't post any of them....sigh.

[cynicom]

snope...shame on you. hehehehe

[xJones]

It's great that it helps the lungs, but the side-effects information sheet must be hilarious.