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Two new pills may join Viagra in impotence market
By WES ALLISON
© St. Petersburg Times, All one needs to say is Bob Dole, ED, or little blue pill, and almost everyone in the room will know the subject. In three years, it has become one of the world's top-selling prescription drugs, the nation's third-most advertised, the only one with a NASCAR car and driver. And since Pfizer dropped it on the market in 1998, Viagra has remained peerless in the large and largely untapped market for impotence medications. By this time next year, however, the scene will have changed. Bayer AG and a partnership of Eli Lilly and Co. and Icos Corp., a West Coast biotechnology firm, have asked the U.S. Food and Drug Administration to approve their own versions of Viagra, setting the stage for aggressive marketing campaigns by all three companies that could test the limits of how much more Americans really want to hear about erectile dysfunction. Lilly Icos' is called Cialis. Bayer's is known now only by its generic name, vardenafil. They face a product with almost 100 percent of the market and a brand name as synonymous with impotence medication as Band-Aid is with self-adhesive bandage. And neither can count on the titillating news coverage that greeted Viagra, which truly was a medical breakthrough. To compete, Lilly Icos and Bayer must show their drugs are better, as well as reach men who don't respond well to Viagra. Independent analysts and doctors familiar with these drugs say Lilly's Cialis appears to offer some advantages. Vardenafil may, too, but it appears to be much like Viagra, and therefore is likely to have more difficulty winning a sizable share of the market, experts say. "Pfizer has done an incredible job with brand-name recognition with Viagra, and that's going to be one of the strengths that the drug will continue to have, that it was first," said Len S. Yaffe, a doctor and drug analyst for Banc of America Securities. "Lilly Icos will have to do a significant direct-to-consumer as well as a doctor education program in order to make significant inroads. We think because (Cialis) is a superior drug that it will," said Yaffe, who has followed Viagra, Cialis and vardenafil since they were in clinical trials. "But it won't happen overnight." The stakes are high. In the 12 months ending June 1, doctors wrote 13.2-million prescriptions for Viagra and sales surpassed $850-million. Some analysts estimate the potential market is three to five times that. Urologists welcome alternatives to Viagra. The little blue pill has proved safe and effective, but some men suffer serious side effects. Others don't respond to it. Impotence affects an estimated 30-million men and can occur because of age, cardiovascular disease or prostate disease, among other things. It's most common in men over 60, but often affects men in their 40s. Smoking, obesity or alcohol abuse can cause it to happen to men in their 30s. Lilly and Bayer will benefit from Pfizer's work toward making erectile dysfunction part of America's vernacular, and in persuading millions of men to ask their doctors about it. Nancy Bryan, vice president of marketing for men's health at Bayer, said company surveys found that 90 percent of physicians and consumers are interested in alternatives to Viagra. And, she noted, only about 11 percent of men with erectile dysfunction have sought treatment. "There's clearly opportunities to expand the market with a second and third product," she said. Dr. Mark Swierzewski, a Tampa urologist who takes questions about men's health on Bubba the Love Sponge's show on WXTB-FM 97.9, writes 250 new Viagra prescriptions each month. He's not convinced the new drugs will be different enough to challenge Pfizer's dominance, but having options always helps, he said. Like Viagra, Cialis and vardenafil are phosphodiesterase-5, or PDE-5 inhibitors, meaning they obstruct a specific enzyme. This sets off a chain reaction that ultimately improves blood flow to the penis. The drugs work about 80 percent of the time, trials show. All three can be trouble for some heart patients and all three have side effects, including flushing, headaches and stuffy nose. Cialis and vardenafil appear to have less severe side effects than Viagra, doctors said. Vardenafil appears to require a lower dose than either competitor, which should cut side effects, and Bayer says it appears quite effective for men with diabetes, whose impotence is difficult to treat. The new drugs also work in about 20 minutes, Bayer and Lilly say. Viagra takes up to an hour. But Cialis' strongest point is its staying power: While Viagra and vardenafil typically work for four hours, about half the men who took Cialis in clinical trials could get an erection any time within 24 hours. For some, the window was even longer. Look for Lilly Icos to promote this heavily. That "is the strongest added value this can bring to the marketplace," said Dr. Gerald Brock, associate professor of urology at the University of Western Ontario and the lead investigator of a large trial of Cialis in Canada. "Men who have problems with erections want to return to normal functions and this drug, I think, will return a lot of them to that ability," said Brock, who has been paid by Lilly for his work. He also has led a trial of vardenafil. But don't look for the manufacturers to stage any comparison tests, experts say. It will be up to the patient and his doctor to sort through the ads and studies and determine which works best. "They'll each have nuances to have these promoted, but drug companies are very, very reluctant to compare them directly," said Mike Krensavage, a pharmaceutical analyst for Raymond James and Associates. "You can have the embarrassing situation where your drug doesn't work as well as a competitor, so you just compare them to placebo. Which is ludicrous because no one takes the placebo." Lilly filed the Cialis application with the FDA two months ago. Bayer filed its application for vardenafil last week and is still awaiting approval of the proposed brand name, which analysts identified as Nuviva. Both are expected on the market by this time next year, and the companies are using the time to ramp up the buzz. Researchers on behalf of both companies will be toting studies touting their virtues to a half-dozen medical conferences in the next six months. Cialis already has a Web site, www.cialis.com. But studies show Viagra is one of the nation's most recognized brand names, and Pfizer spent $107.8-million last year on consumer advertising. "Viagra is more like Xerox. People come in asking for Viagra, they don't come in asking for their ED pill," Swierzewski said. "So they have an uphill battle."
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