Motley fool on ZONA:
fool.com
HOW DID IT FIND TROUBLE?
A year ago, shares of Zonagen swelled to $40 as Viagra fever sent speculators looking for other companies with a potential fix for male erectile dysfunction.
That ecstasy couldn't last, but the stock was still hanging around the mid-$20s in July when Zonagen and partner Schering-Plough (NYSE: SGP) announced they had submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Vasomax, their Viagra wannabe. In September, the FDA accepted the application for review.
However, this titillating foreplay led to a disappointing climax on May 10.
That's when Zonagen announced that the two firms were suffering performance anxiety and would forego a scheduled June appearance before an FDA advisory panel. That's usually the last major hurdle before negotiating the details of a formal marketing approval. The company has basically accepted an FDA thumbs-down for now.
The data from Zonagen's two Phase III trials apparently didn't present the kind of safety and efficacy profile Schering-Plough needs to win broad marketing approval -- and Vasomax needs such approval to have a chance against Viagra. The plan now is for Schering-Plough to submit data from some additional clinical trials as part of an amended NDA. This data "should maximize our product's potential in the marketplace," according to Zonagen CEO Joseph Podolski.
However, investors who thought they might see Vasomax marketed this year in the U.S. will now have to wait until at least next year. That news neutered many Zonagen bulls, who have repeatedly confronted serious doubts from short-sellers. Left impotent by the news, many investors sold, cutting Zonagen's share price in half in one day.
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A more recent study of 2,000 patients reportedly found that 69% of men
studied responded well. Though phentolamine can trigger a drop in blood pressure, the clinical trials of Vasomax have found its major side effect to be a stuffy nose, experienced by no more than 18% of patients.
(All courtesy by TMF)
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