To: VLAD who wrote (6590 ) 5/10/1999 4:07:00 PM From: Linda Kaplan Read Replies (2) | Respond to of 7041
Vlad: I was interrupted too often and haven't listened to the call as yet. I will look forward to it tonight. Drifting down is how I see it, too. No credibility to the company now, even their hype, but I'll probably have more to say after I listen to the call. Meanwhile here's the latest news item: Headline: (UPDATE) Zonagen Shares Tumble As Review Of Impotence Drug Is Put On Hold ====================================================================== THE WOODLANDS, Texas -(Dow Jones)- Shares of Zonagen Inc. plunged Monday after the company said its experimental impotence drug Vasomax won't be reviewed by a Food and Drug Administration advisory panel next month, as had been planned. In late-afternoon trading, shares of Zonagen (ZONA) were down $9.063, or 46%, at $10.75 on volume of 4.2 million. If eventually approved by the FDA, Vasomax would compete with Pfizer Inc.'s Viagra. Industry analysts have said safety data from trials of Vasomax trials were good, but indicated Viagra is seen as more potent. The experts don't expect Vasomax, if approved, to reach the blockbuster status that Viagra has attained. Zonagen and Schering-Plough Inc., which would market Vasomax, said they have agreed to forego the planned June review by the FDA panel until Schering-Plough (SGP) submits additional clinial studies. Zonagen expects to submit the data as an amendment to the new drug application. The companies are "committed to obtaining approval of Vasomax with the optimal safety and efficacy product profile." As a result of the companies' decision to forgo the panel review, Zonagen said it expects the FDA will issue a "non-approvable" letter for Vasomex's new drug application, as currently filed. The company said it expects that additional data from Schering-Plough's studies will "enhance the regulatory filing and the commercial product profile for Vasomex." Schering-Plough is continuing to seek regulatory approvals for Vasomax in other countries, having launched the drug in Mexico last June and in Brazil last month. A regulatory application was filed in the United Kingdom in August 1998 as the first step for approval in the European Union. Copyright (c) 1999 Dow Jones & Company, Inc. All Rights Reserved.