| FIRST
Of Two Viagra Rivals OK'd For Sale
August 21,
2003
The Food and Drug Administration
has approved the first serious competition for
Viagra, the little blue blockbuster that revolutionized
the treatment of impotence -- and more rivals
are on the way
Levitra, a drug that combats
erection problems in much the same way as Viagra
but reportedly more quickly, taking effect in
as little as 16 minutes, is expected to become
available in pharmacies within weeks following
the FDA
approval late on Tuesday.
A third drug, Cialis,
which also works similarly but lasts much longer,
offering 36 hours or more of improved erections,
is awaiting a final FDA decision late this year
and could come to the US market within months,
its makers say. Both drugs are already sold
in Europe.
With Levitra and Cialis on their
way and other
impotence treatments under development,
Viagra appears on the verge of losing its status
as the only drug for the erectile dysfunction
problems believed to affect some 30 million
men in the United States.
The pill brought impotence into
the open and brought in billions of dollars
for its maker, Pfizer Inc., but now it will
have to fight for market share. Stay tuned,
market analysts say, for a battle to get men's
attention during Sunday football games; the
makers of Levitra, Bayer and GlaxoSmithKline,
have already signed on the services of legendary
coach Mike Ditka.
Viagra is a wonderful drug, said
Dr. Irwin Goldstein, director of Boston University's
Institute of Sexual Medicine, but "now
it's five years later, and there is competition,
and I think all of this is very good for the
field."
In particular, he said, some
men fear Viagra because of the perceived health
risk: "They link the word `Viagra' to the
words `heart attack,' " Goldstein explained,
noting that the risk is very slight. "I
think having a new medication that doesn't have
that sort of baggage may be very beneficial
to the field."
In truth, Levitra poses heart
hazards similar to Viagra. Men who are taking
nitrate medication like nitroglycerin to treat
chest pain or alpha blockers for blood pressure
or prostate problems are not supposed to take
Levitra, according to Bayer and GlaxoSmithKline.
The FDA does not recommend the drug for people
whose heart disease makes sex dangerous or who
have had a recent heart attack or stroke.
In clinical trials of Levitra
among more than 5,000 men, the most common side
effects reported were headaches, flushing, indigestion,
and nasal stuffiness. A few patients reported
abnormal vision.
Viagra, Levitra, and Cialis all
work by blocking an enzyme to allow better blood
flow to the penis, and all have been shown to
be effective at helping at least six or seven
of every 10 men who have erection problems.
No studies have pitted Viagra
directly against Levitra, but market analysts
predict that the two drugs will be battling
it out in the US consumer market.
Viagra had Bob Dole as a poster
boy; Levitra will use former Chicago Bears coach
Ditka for an "educational campaign"
called "Tackling Men's
Health," said Nancy Bryan, vice president
for marketing in men's health for Bayer Pharmaceuticals.
Bayer has also signed a sponsorship
deal with the National Football League, and
Bryan said it hopes to reach 120 million men
through ads during football games.
And Levitra's price, Bryan said,
"is going to be competitive with Viagra."
Viagra generally costs $10 or $12 a pill, though
it is often covered by insurance.
Levitra already has some enthusiastic
fans. One of Goldstein's patients, a 68-year-old
diabetic who identified himself only as Jason,
said the drug worked for him so much better
than Viagra that "I told Bayer I wanted
to open my mouth under the conveyor belt."
But a Pfizer spokesman challenged
the claims that Levitra acts faster or better
than Viagra. (The usual time given for Viagra
to take effect is an hour, but Pfizer said that
in tests, it often acts faster.)
"We don't see it as much
competition, to tell you the truth," said
the spokesman, Daniel Watts. "It's another
choice for patients, but based on the data and
the labeling the FDA has given the product,
they're not superior to us in any way, so we
remain the gold standard."
And in terms of marketing, he
said, "We're going to continue doing what
we've been doing," such as sponsoring a
car in NASCAR races and getting endorsements
from the likes of soccer star Pele.
Pfizer has worked hard to bring
impotence out of the closet, and Levitra's makers,
too, talk about reducing stigma and prompting
men to seek treatment. "The real opportunity
here is to expand the marketplace," Bryan
said.
Of the estimated 30 million American
men with erectile dysfunction, only about one-tenth
use Viagra.
But in Europe, where all three
drugs are on sale, initial indications are that
Levitra and Cialis do pull consumers away from
Viagra and don't bring in new patients for treatment
as quickly as hoped.
Sales of the new drugs "are
eating away at Viagra's sales, and unfortunately,
the broadening of the market that everyone expected
is happening at a slower pace than they want,"
Goldstein said.
His center has performed clinical
trials on all three of the drugs, and received
money for the tests from all the drug companies.
He said Levitra, whose chemical name is vardenafil,
does a better job than Viagra biochemically
at blocking the enzyme. It also has the advantage
of not needing to be taken on an empty stomach.
For its part, Cialis does have
the advantage of lasting a day and a half, compared
with about 12 hours for Viagra and about 15
to 18 for Levitra, he said.
Carole Copeland, a spokeswoman
for the joint venture between Eli Lilly and
a biotech company called ICOS, which are working
together on Cialis, said: "It offers a
longer window of opportunity for intimacy, and
that's what men and their partners say they
miss most when they have erectile dysfunction:
those special moments that just come naturally."
Ultimately, Goldstein said, each
of the impotence drugs could find its own niche.
It could be that some patients
will be swayed by actor Paul Newman's connection
to Cialis, he said, or Ditka's role in the Levitra
campaign. Or it could be that the same person
will use Levitra or Viagra during the week and
Cialis on Friday night.
"I think choice will be the
inevitable consequence, and that has to be good,"
he said.
Carey Goldberg can be reached
at Goldberg@globe.com.
source:-http://www.boston.com
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