FDA Accepts Zonagen's Impotence Drug Vasomax For Review
By Melanie Trottman, Staff Reporter
09/24/98
Dow Jones Online News
NEW YORK -(Dow Jones)- A potential new contender in the market to treat male erectile dsyfunction has passed another milestone.
Zonagen Inc. (ZONA) said Thursday that the Food and Drug Administration agreed to review the company's new drug application for Vasomax, a pill to treat the condition that would compete with Pfizer Inc.'s blockbuster drug Viagra .
The FDA's filing acceptance generated a $5 million milestone payment for Zonagen from Schering-Plough Corp. (SGP). Vasomax was licensed to Schering-Plough in November under conditions that the Madison, N.J., maker of health-care products would pay Zonagen $10 million up front and make subsequent milestone payments as specific regulatory goals were achieved. If Zonagen meets all the goals, the up-front and milestone payments will total $57.5 million; that doesn't include royalties.
A Zonagen spokeswoman declined to comment directly on the stock increase but said, "I presume people assume it's a positive event for us."
The company presented results from its late-stage, or Phase III, trials of Vasomax at the American Urology Association meeting in early June. As reported in The Wall Street Journal, results showed that 37% to 45% of about 300 patients taking Vasomax achieved better erections than without the drug. Pfizer Inc.'s (PFE) Viagra helps about 70% of impotent men.
Industry analysts who follow the company said safety data from the Vasomax trials were good, but indicated Viagra is seen as more potent. They don't expect Vasomax, if approved, to reach the blockbuster status that Viagra has attained.
"It's slightly less effective and it comes second" to market, said Mehta Partners analyst Sergio Traversa, adding that he is neutral on the company.
Analysts estimate Vasomax would seize a market share equal to about 25% of Viagra 's. Part of that is seen coming from an expansion of the impotence market, while another portion is expected to come from patients who have had no success using Viagra . They would likely be the first to try Vasomax, analysts said.
Other companies working to get products for erectile dsyfunction to market include MacroChem Corp. (MCHM), which recently said interim-stage clinical trials supported the effectiveness and safety of its Topiglan gel.
Also, TAP Holdings Inc., a joint venture of Abbott Laboratories (ABT) and Takeda Chemical Industries Ltd. of Japan, is developing apomorphine, which acts directly on the brain to create erections.
Researchers have cautioned that none of the drugs has been directly compared with Viagra in scientific studies, so definitive conclusions can't be drawn.
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