More info about the Vasomax filing from Bloomberg:
Zonagen Impotence Pill Clears First Step to Compete With Viagra
Bloomberg News
July 15, 1998, 5:34 p.m. ET
Zonagen Impotence Pill Clears First Step to Compete With Viagra
Washington, July 15 (Bloomberg) -- Zonagen Inc. said it
filed an application with the U.S. Food and Drug Administration
for clearance to sell what would be the first challenger to
Pfizer Inc.'s record-selling Viagra impotence pill.
Called Vasomax, the pill would be Zonagen's first drug on
the market, and would pit The Woodlands, Texas-based company
against Pfizer, the second largest U.S. drugmaker, in a battle
for the burgeoning impotence drug market.
Vasomax would be sold by Schering-Plough Corp., which last
year entered the impotence drug fray by acquiring the rights to
market the drug from Zonagen.
Shares in Zonagen fell 2 11/16 to close at 22 15/16. Shares
in New York, New York-based Pfizer fell 2 1/2 to 116. And shares
in Schering-Plough fell 1 1/16 to close at 102 5/8.
''This event marks a major milestone for Zonagen,'' said
Joseph Podolski, president and chief executive officer for the
company.
Analysts estimate that sales for Viagra, which ignited a
previously sleepy impotence drug market, will reach $2 billion
next year. While Zonagen's drug is expected to work only in about
30 to 40 percent of men as compared to Viagra's 70 percent of
users, the drug is believed to be faster acting and perhaps to
carry fewer side effects, qualities that could boost sales and
help Vasomax compete against Viagra.
Still, when the results of a large trial confirmed that the
newer drug didn't work as well as Viagra, shares in Zonagen fell
about 15 percent.
An estimated 48 million men between the ages of 40 and 70
in Canada, the U.S. and Europe may suffer from impotence of some
form, Zonagen said. The drug has been shown to work in about 30
to 40 percent of men with mild to moderate problems getting or
keeping an erection, the company said.
Zonagen said it expects to hear from the FDA within 60 days
as to whether its application was accepted for evaluation, and
the FDA could issue a decision on the drug within the next 14
months.
Vasomax makes it possible for a man to attain or to maintain
an erection by increasing blood flow into the genital area and
relaxing the smooth muscles of the penis. Pfizer's Viagra has
the same effect but triggers the blood flow in a different way.
The major side effect of Zonagen's drug is a stuffy nose,
which occurs in about 17 percent of those taking the highest dose
of Vasomax.
Other companies developing oral drugs to treat the erectile
disfunction condition include Abbott Laboratories and Japan's
Takeda Chemical Industries, whose Apomorphine tablet will likely
be ready for government review in about a year. And Pharmacia &
Upjohn Inc. has said it is developing a treatment as well.
--Kristin Reed in Washington (202) 624-1858/ mfr |
