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Viagra rivals may emerge
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June 6, 2000: 2:55 p.m. ET
Impotence drug Uprima has partial FDA OK; consumer activists call drug unsafe
By Staff Writer Martha Slud
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NEW YORK (CNNfn) - When Viagra was introduced two years ago, men from Iowa to Indonesia went running to their doctors in hopes of reviving their sex lives through the diamond-shaped blue pills. Now the drug -- which became a pop culture phenomenon and a fixture of late-night TV gags, as well as a blockbuster product generating roughly $1 billion in annual revenues for its creator Pfizer Inc. - may have rivals.
In fact, another potentially lucrative sex remedy for men - touted as more effective than Viagra - could soon go on the market.
Later this year, TAP Pharmaceuticals, a joint venture between Illinois-based Abbott Laboratories (ABT: Research, Estimates) and Takeda Chemical Industries Ltd. of Osaka, Japan, hopes to introduce the experimental erectile dysfunction drug Uprima. A U.S. Food and Drug Administration advisory panel gave the prescription-only treatment conditional approval in April, and full agency clearance could come as early as July 1.
 But consumer group Public Citizen has raised questions about Uprima's safety, saying that clinical trials have shown the treatment can cause serious side effects including loss of consciousness, as well as nausea and mouth ulcerations.
According to Public Citizen, an analysis of the clinical trial results of Uprima shows that the drug is only "marginally effective at the lower dose and to have significant, life-threatening toxicity at the higher dose." Also, although the drug's proposed labels will spell out that Uprima can have serious interactions when taken with alcohol, those warnings are likely to be ignored by many men eager to have sex, the Washington-based group warned.
"If the FDA approves this drug, it is certain that it will have to be banned within a short time after marketing begins because of the high probability of further occurrence of the serious injuries it has already been found to cause," Public Citizen director Sidney Wolfe wrote in a letter to the FDA's director of drug reviews, Janet Woodcock. The letter was released Monday.
An FDA spokeswoman told CNNfn.com that the agency would look carefully at the issues raised in the Public Citizen letter, but declined further comment, citing the ongoing review of the proposed product.
Recently, however, the FDA scolded TAP Pharmaceuticals for publishing a press release about Uprima that touted the drug's purported benefits without discussing its risks.
TAP Pharmaceuticals said Tuesday that it was confident that Uprima will be approved, saying that the FDA panel in April already decided that the drug's potential side effects were minimal.
"We're very confident in Uprima," said company spokeswoman Kim Modory. "All of those things [side effects issues] were discussed, and the expert panel still voted very favorably for Uprima." Also, the company recently gave the FDA some additional safety data to assure regulators about the drug, she said.
Viagra: A success story
Viagra, the first pill ever to be approved in the U.S. to treat impotence, is one of the most successful new drugs ever to go on the market. Its introduction in early 1998 helped spawn a vast new sector of so-called "lifestyle drugs" in the United States - including remedies for conditions such as obesity or excessive shyness.
Viagra's extraordinary popularity also encouraged other drug makers to look to the once-ignored male impotence problem as a potential windfall.
In addition to TAP Pharmaceuticals' proposed treatment, Germany's Bayer AG disclosed last week that it also is testing a new male impotence remedy. Meanwhile, Schering-Plough Corp. (SGP: Research, Estimates) and Zonagen Inc. (ZONA: Research, Estimates) are developing a drug called Vasomax. Eli Lilly and Co. (LLY: Research, Estimates) also is working on an impotence treatment.
 Uprima targets the same market as Viagra, but is designed to work differently. The drug aims to stimulate mechanisms in the brain to trigger an erection, whereas Viagra is intended to boost blood flow to the penis.
Uprima works in a quicker amount of time than Viagra, according to TAP's clinical trial findings. In clinical trials, some men obtained erections in as fast as 10 minutes, according to the company's research. The company also says that unlike Viagra, food does not interfere with the drug.
If approved, the drug likely will attract many men who have been unable to be treated through Viagra, said pharmaceutical analyst Mariola Haggar, fund manager of Haggar Concord Partners, which runs a diversified health care fund. Men who take drugs containing nitrates - which are often prescribed for chest pains -- are not supposed to take Viagra, because of potentially dangerous drops in their blood pressure.
"We believe that it will find its place in the market because about 20 to 30 percent of patients do not respond to Viagra," she said. "These would be patients that would be candidates for Uprima."
However, she said, Uprima also appears to be linked to more side effects than Viagra, "so it won't be as broadly used."
When Viagra was introduced, many observers thought the drug would be merely a fad and that sales would peter out, Haggar said.
But the market appears to be here to stay, she said. According to pharmaceutical industry estimates, as many as 30 million American men suffer from some form of erectile dysfunction.
"I think sexual dysfunction is definitely a real market," she said. 
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