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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Craig Markell who wrote (6224)	2/24/1999 8:19:00 AM
From: Manzanillo	Read Replies (2) \| Respond to of 7041

Is Bill Wexler still around?? <<<Schering-Plough bolsters faith in impotence drug By Ransdell Pierson NEW YORK, Feb 23 (Reuters) - Schering-Plough Corp <SGP.N> has bolstered investor faith that its experimental anti-impotence pill Vasomax will win U.S. marketing approval by beginning production of the pills, analysts said. Schering-Plough obtained global marketing rights to Vasomax from Texas-based Zonagen Inc <ZONA.O> in 1997. The active ingredient of the product, phentolamine, has previously been marketed by other drug makers as a treatment for hypertension. Shares of both companies rose Tuesday after they confirmed that Schering-Plough had begun to scale up production of Vasomax. Schering-Plough closed up 2-3/16 to 55-1/4, while Zonagen climbed 2-1/8 to 28-5/8. Zonagen last July requested approval from the U.S. Food and Drug Administration to market Vasomax, a drug described by some analysts as significantly less potent but possibly safer than Pfizer Inc's <PFE.N> blockbuster pill Viagra. The FDA typically takes one year to review drug applications and is therefore expected to render its decision on Vasomax by mid-summer, said CIBC Oppenheimer analyst Matthew Geller. "The fact that Schering-Plough has begun manufacturing Vasomax shows its faith in the safety and effectiveness of the compound. When a company begins making a drug awaiting FDA action, it usually means the company expects FDA approval," Geller added. Viagra, launched in the United States in April 1998, garnered Pfizer global revenues of $788 million last year. An estimated 3.5 million people have taken the blue diamond-shaped pills that increase blood flow to the penis. But safety concerns have dogged Viagra, which is used mostly by elderly men and can cause dangerously low blood pressure if taken with "organic nitrate" drugs such as nitroglycerine. As of late November, the FDA had received reports of 132 deaths among people taking Viagra, although none of the fatalities has been directly linked to the drug. Viagra's package-insert label encourages patients with a history of heart attack or severely low blood pressure to be carefully examined before getting a prescription. By contrast, Geller said trial data indicate that Vasomax caused no significant cardiovascular side effects. "Vasomax certainly looks safe," Geller said, although about 18 percent of patients taking the highest 80 mg dose of the drug experienced nasal congestion. He said Schering-Plough would no doubt trumpet Vasomax safety claims in an effort to win over patients with histories of cardiovascular problems, and possibly achieve annual sales of $500 million by 2002. Hemant Shah, an independent New Jersey drug analyst, was far less optimistic. He predicted Vasomax would become merely a niche product with peak annual sales closer to $200 million. "Vasomax will be mostly a second-step therapy for those unable to take Viagra," Shah said, adding that the Vasomax insert label will likely also carry a safety warning. "Labels for all impotence drugs, including Vasomax, will probably need to carry some warning that sexual activity itself can raise blood pressure" and thereby increase health risks to the elderly, Shah said. Zonagen has said that 53 percent of test patients taking an 80 mg dose of Vasomax achieved sexual penetration 75 percent of the time, versus 38 percent of patients taking a placebo. In 21 Viagra trials involving 4,500 patients, Pfizer said the favorable response rate was 59 percent among those with organic causes of impotence, 81 percent among those with psychological causes and 74 percent with mixed causes. 22:01 02-23-99 >>