Vigra Rival Has Disappointing Tests
Associated Press Online - May 10, 1999 18:17
By PHIL GALEWITZ
AP Business Writer
NEW YORK (AP) - A potential competitor to the blockbuster impotence drug Viagra won't be available for at least a year because its sponsors need more time to prove it works.
Schering-Plough Corp. and partner Zonagen Inc. said Monday they will postpone completing the Food and Drug Administration review process for their experimental pill Vasomax.
The news sent stock in Zonagen, a tiny biotech company based outside Houston, plummeting nearly 50 percent Monday. It fell $9.13 to close at $10.69 on the Nasdaq Stock Market. Shares of Schering-Plough, a much bigger company whose stock isn't dependent on the drug, rose 44 cents to $50.44.
Viagra, introduced by Pfizer Inc. in April 1998, had $788 million in U.S. sales last year. The first pill to treat impotence became an instant success, and is the fastest selling new drug in history.
But, Viagra, at about $8 a pill, is expensive and competition could help drive down the cost.
Zonagen, which is developing Vasomax, joined with Schering-Plough in November 1997. Zonagen, which has no drugs on the market, applied for FDA approval in July 1998, and approval was expected this summer. The drug is approved for use in Mexico under the brand name Z-Max.
"Although we are disappointed with this delay, we believe that the additional data from Schering-Plough's studies are important to the long-term success of Vasomax," said Joseph S. Podolski, Zonagen's president and chief executive officer.
Neither Zonagen nor Schering-Plough would release the results of the tests that prompted the delay in the drug application.
Neil Sweig, an analyst with Southeast Research Partners, said Zonagen's early studies show that Vasomax is not nearly as effective in producing an erection as Viagra.
He said the studies show Vasomax only effective about 40 percent of the time compared to about 70 percent for Viagra. "This announcement is without doubt a most unwelcome surprise," Sweig said.
Podolski acknowledges some data shows Vasomax lacking against Viagra. But he contends there are many ways to measure success.
He said he hopes that after the additional studies are completed the company will show that the drugs work similarly.
Podolski predicted that Vasomax will be proven safer than Viagra in men with heart trouble. Viagra is dangerous when taken by those who also take certain heart drugs such as nitroglycerin. Also, Vasomax works in about 15 to 30 minutes, about twice as quick as Viagra, Podolski said.
The delay in Vasomax will likely put its sponsors behind TAP Pharmaceuticals in the race to launch the first Viagra competitor
TAP, a joint venture between Abbott Laboratories and Japanese drugmaker Takeda Chemical Industries, Ltd. expects to seek federal approval for its anti-impotence pill Uprima in the next few months.
Last week, TAP presented data at a medical conference showing the largest dose of Uprima is 61 percent effective compared to 29 percent for a dummy pill
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