Zonagen Shares Tumble As Review Of Impotence Drug Is Put On Hold
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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 morning trading, shares of Zonagen (ZONA) were down $9.719, or
49%, at $10.094 on volume of 1.4 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.
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