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

To: chester lee who wrote (4528)	6/11/1998 12:35:00 AM
From: Linda Kaplan	Respond to of 7041

Thanks. I think this deserves a reprint right here, though. Let's spring for that. It was released yesterday, prior to the bell. As the news gets around the stock may have more of a reaction. I don't suppose anyone said WHY the filing is delayed again? ZONA delays NDA 6 to 8 more weeks ************* Top Stories: Exclusive Zonagen's NDA May Face Another Delay By Jesse Eisinger Senior Writer 6/10/98 3:49 PM ET Schering-Plough (SGP:NYSE) says the new drug application for Zonagen's (ZONA:Nasdaq) impotence drug Vasomax will be delayed "about six to eight weeks," according to an investor who attended a presentation by the president of Schering-Plough Pharmaceuticals at the Goldman Sachs health care conference in California. Zonagen's new drug application, or NDA, with the Food and Drug Administration has long been delayed. The company originally said it could file Vasomax in mid-1997 and then moved the filing back to the end of last year. Most recently the target has been the first half of this year. Schering-Plough licensed marketing rights from Zonagen at the end of last year. Despite the possible delay, Wall Street watchers don't believe Schering-Plough is about to back away from Zonagen. Matt Geller, who rates Zonagen a buy at Oppenheimer, said this morning that "my sense is that Schering-Plough is very committed to the project and will continue to demonstrate its commitment." Short-sellers have questioned how rigorously the Vasomax clinical trials were conducted, how severely impotent the patient population was and whether there are safety concerns with the blood-pressure-lowering drug. (TSC covered this issue recently in a story from the American Urological Association meeting.) In the Goldman presentation, Raoul Cesan, president of Schering-Plough Pharmaceuticals and an executive vice president of the company, told investors, "As you know, they announced, I think it was last week, that they are going to file in about six to eight weeks." A short-seller who asked not to be identified taped the presentation and replayed the tape for TSC. It is not clear what announcement Cesan is referring to. Neither company has announced recently that there would be a delay in the filing. In the break-out session after the presentation, Cesan was asked who is handling the filing of the NDA and answered that Zonagen is. He didn't offer a substantive answer when asked whether Schering-Plough "clinical" or "regulatory" folks are helping with the filing, according to the short-seller in attendance. David Ferguson, a consultant who has worked with Zonagen on its Vasomax application, said Schering-Plough is involved in the FDA application process with Zonagen. "The specific wording of the agreement is that Zonagen will be filing. However, Schering-Plough has taken, I guess, what you might call a majority role in the process, as you might expect," he said. Dr. Ferguson added that Schering-Plough has "a full NDA team [working on the application] -- regulatory, statistical and clinical." In addition, Dr. Ferguson, citing his confidentiality agreement with Zonagen, said he could neither confirm nor deny whether the Vasomax filing had been delayed. Repeated calls to Zonagen were not returned. A spokesman for Schering-Plough didn't return a call, either. Rumors of another filing delay have surfaced in the last several days and there has been a suggestion that the FDA may want more safety data on Vasomax. Rumors from Zonagen supporters are that Schering will make a payment to The Woodlands, Texas, company to compensate for the delay. However, if the responsibility for the filing is on Zonagen's head, such a payment might not happen.