wilson

By Rob Waters Nov. 18 (Bloomberg) — Vivus Inc ., an unprofitable biotechnology company, said its experimental impotence drug helped men achieve erections in as little as 30 minutes in a study, or about twice as fast as Pfizer’s Inc.’s Viagra. Data showing the drug, called Avanafil, acts quickly will help Vivus seek U.S. permission to enter the $3.7 billion erection-drug market in 2011, said Chief Executive Officer Leland Wilson . Vivus shares rose as much as 12 percent. Wilson said he may introduce Avanafil in early 2012. As many as 322 million men worldwide may have erectile dysfunction by 2025, according to an Oct. 19 report by the American College of Physicians. Avanafil will grab market share because it works faster than the market-leading Viagra, which takes an hour to produce results and Eli Lilly & Co.’s Cialis, which takes about two, Wilson said in a telephone interview. “Patients want on-demand therapy because when the mood is right, the mood is right,” Wilson said. “We’ve shown efficacy in 30 minutes and no one else has done that.” Vivus jumped 48 cents, or 5.6 percent, to $9.05 at 10:06 a.m. New York time in Nasdaq Stock Market composite trading, after earlier touching $9.60. The company had risen 61 percent in the year before today. Avanafil could bring in $350 million by 2015, grabbing about the same market share as Levitra, said Jason Butler , an analyst for JMP Securities in New York, in a telephone interview yesterday. The key, he said, will be for Vivus to find a partner willing to spend money on promotion. Viagra, Cialis, Levitra In 2008, Viagra, made by New York-based Pfizer, the world’s biggest drugmaker, had about half of the erectile-dysfunction market. Cialis, made by Indianapolis, Indiana-based Eli Lilly & Co . had 40 percent and Levitra, made by Germany-based Bayer AG 10 percent. “This is a hugely promotion-driven market,” he said. “Viagra and Cialis win because they have sales reps that call on doctors every day of the week and they spend a huge amount on advertising.” Vivus won U.S. approval for its first erection product Muse in 1996, two years before Viagra was cleared for sale. Muse, a product designed to push erection-boosting medicine into the urethra, was quickly displaced by the little blue pill Viagra. Muse had revenue of $18.05 million last year. Vivus also is competing to introduce a new weight-loss drug for obesity patients with Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc. , both based in San Diego. The Mountain View, California-based company has said it will seek permission from the Food and Drug Administration to sell the treatment, Qnexa, by the end of the year. Partnership Needed While Vivus needs to form a partnership with a major drugmaker to market its erectile dysfunction pill, Wilson said he may wait to make a deal until the company has completed its clinical trials and submitted its application to the FDA. “As we move forward, it will increase our value,” he said. The Vivus study compared three doses of Avanafil to placebos in 646 patients with erectile dysfunction , a condition that affects 15 to 30 million U.S. men, according to a National Institutes of Health Web site. Before the late-stage study, 12 to 14 percent of men achieved erections that allowed them to have sexual intercourse. Men taking the lowest 50-milligram dose got erections 40 percent of the time, while those taking either the 100 milligram or 200 milligram doses achieved erections 57 percent of the time, according to a Vivus statement. Men taking placebos were able to have sex 27 percent of the time. Visual Distortions None of the patients had visual distortions such as those reported rarely by some Viagra and Cialis patients who said the drug added a blue tinge to their vision, Wilson said. The visual changes on those pills cleared up within a few hours, according to an Indiana University study reported April 13. About 85 percent of patients taking the Vivus drug completed the 16-week study. The most-common side effects were headaches, experienced by 7 percent of the men, facial flushing, experienced by 4.6 percent and nasal congestion, experienced by 2.3 percent. Patients in the study were men older than age 18 who had erectile problems for at least six months and excluded those taking nitrate heart medicines. Men using these medicines are also warned not to take the erectile dysfunction drugs on the market. Trials are under way for patients whose erection difficulties are linked to their diabetes , one of the most common causes of impotence, and for men who had surgery for prostate cancer, Wilson said. Viagra works within 30 minutes to 2 hours, according to prescribing information on the drug’s label. The median time to effectiveness is 60 minutes. Cialis, when taken as needed, can work within 30 minutes to 6 hours, according to prescribing information , with effectiveness achieved after a median of 2 hours. The drug can also be prescribed for daily use. To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .