Viagra's Rivals Share the Spotlight at Impotence Conference
Bloomberg News
August 24, 1998, 2:29 p.m. ET
Viagra's Rivals Share the Spotlight at Impotence Conference
Amsterdam, Aug. 24 (Bloomberg) -- Some 1,300 doctors and
scientists are meeting at an international convention on sexual
dysfunction that opened today -- the first major conference on
impotence since Pfizer Inc. launched its blockbuster Viagra pill.
The 8th World Meeting on Impotence Research is held in the
week that Pfizer's pill faces scrutiny by European Union drug
regulators who'll advise on approval of the drug in Europe. The
conference will feature details on Viagra and on rival drugs such
as a gel by MacroChem Inc. and an injection by Schwarz Pharma AG.
Viagra reaped $411 million in sales within three months of
its April launch, and this week's conference should shed more
light on a market worth as much as $4 billion in annual sales,
according to analysts, and could offer hope to 50 million men --
and their partners -- in Europe, the U.S. and Japan.
''Future alternatives could be topical gels,'' said Annika
Espander Jansson, a healthcare analyst at Enskilda Securities,
adding that one of the main themes of the meeting will be ''a
continuous discussion on the side-effects of Viagra.''
Pfizer will present research on the safety of Viagra after
Washington-based watchdog Public Citizen said Aug. 20 the drug
should be reviewed by the U.S. Food and Drug Administration due
to safety concerns. On July 21, the FDA said 39 men who took
Viagra in the U.S. later died, though that hasn't caused the
agency to change its stance that the drug is safe; many of the
men had been taking heart drugs known to have danger interactions
with Viagra.
As well as hearing from Pfizer about studies on Viagra's
safety and effectiveness, the conference will see the results of
new studies on Viridal, or Idix, an injected potency drug from
German drugmaker Schwarz Pharma, and Topiglan, a potency gel from
U.S. company MacroChem.
Easier to Use
Sales of Viagra, the first pill for impotence, took off
after it was introduced in April because it's easier to use than
previous treatments, analysts say. The drugmaker said July 9
that second-quarter profit rose 38 percent on the introduction of
Viagra. The shares have rocketed on the prospects for the drug,
and are up 42 percent to 105 3/4 this year.
The alternatives to the pill include injected impotence
drugs, such as Pharmacia & Upjohn Inc.'s Caverject and Schwarz
Pharma's Viridal, and Vivus Inc.'s Muse, a pellet that's
injected in the urethra.
At the Amsterdam meeting, scientists will present the
results of a comparative study between Viridal and Muse, in which
95 patients received both drugs and were tested for penile
response. Another study assesses the pain that patients associate
with potency injections.
U.K. drugmaker Senetek Plc will be presenting new data on
its injectable impotence drug Invicorp, which is still
undergoing approval tests.
Enskilda analyst Jansson said injections and pellets are
awkward to use. ''I do think those topically administered
drugs will prove to be important,'' Jansson said.
Impotency researcher Irwin Goldstein will present results
of a phase 2 trial of U.S.-based MacroChem's Topiglan. The
gel allows a common anti-impotence drug to be absorbed into the
surface of the skin on the penis, helping a man achieve an
erection. NexMed Inc. of the U.S. is also testing a topical gel.
Rival Makers
Rival pill-makers to Pfizer include U.S. drugmaker Zonagen
Inc. with its Vasomax drug, a pill like Viagra but quicker to
work. Zonagen may be presenting new data from phase 3 trials,
the last phase of testing required for regulatory approval, at
the impotence conference.
Another competitor is Icos Corp., a U.S. biotechnology
company with a pill in the second phase of testing. The drug
could go into the final phase of testing by the end of the year,
analysts said.
Like Viagra, the pills work by stopping enzymes thought to
prevent erections by blocking the flow of blood to the penis.
Biotech company Icos said its drug appears to act on just one of
these kinds of enzymes, known as phosphodiesterases, while
Viagra may affect others. Drugs that target enzymes more
specifically produce fewer side-effects.
Physicians will also have a chance to review clinical trials
of apomorphine, another Viagra wannabe that's being developed by
Japan's Takeda Chemical Industries and Abbott Laboratories of the
U.S. In June, the first data on large-scale trials of that oral
drug showed that it enabled men to have intercourse 51 percent of
the time they took it.
Apomorphine is about a year behind Vasomax in the
development process. The drug is a tablet placed under the
tongue, which could enable it to take effect faster than a
swallowed pill like Viagra.
The meeting also spotlights the problem of female sexual
dysfunction, which could offer drugmakers a huge new market for
their impotence treatments. Already, women are using Viagra on
their own and Pfizer has begun testing its star drug to see if
it improves women's sexual functioning.
EU Scrutiny
Viagra this week faces scrutiny by a committee of European
Union drug regulators, who'll recommend whether the European
Commission, the EU's executive arm, approve its sale.
Viagra got the backing of the European Medicines Evaluation
Agency, an expert panel that advises European regulators on drug
approvals, on May 29. Final approval from the commission usually
comes two to three months after EMEA approval.
Pfizer's Swiss unit said today that it sold about 15,000
Viagra pills in the first month after its introduction in
Switzerland -- the first European country to approve Viagra -- in
what Pfizer said was the country's most successful launch of a
new drug. Pfizer began selling the drug there at the end of June.
Switzerland isn't in the EU.
The impotence-research meeting, hosted by Amsterdam
university Vrije Universiteit, started today and will run though
Friday, Aug. 28.
--Rudy Ruitenberg in the Amsterdam bureau (31-20) 589 8507 with |
