Viagra Intensifies War Among Impotence Hopefuls: Medical Market
Bloomberg News
May 26, 1998, 12:55 p.m. PT
Viagra Intensifies War Among Impotence Hopefuls: Medical Market
San Diego, May 26 (Bloomberg) - Now that Pfizer Inc.'s
Viagra pill has established itself as the first-line treatment
for impotence, other companies are competing to treat the one-
third of impotence patients who don't respond to Viagra or can't
take it.
''For people who fail Viagra, there is a real battle for
second line therapy,'' said Steve Lisi, a drug-industry analyst
with Mehta Partners. As the nation's urologists gather next
weekend for the American Urology Association's annual conference,
''this is a hot topic,'' he said. ''It's going to be what takes
up most of the AUA meeting.''
Schering-Plough Corp. last year joined the game by acquiring
the rights to market Zonagen's Inc.'s Vasomax pill if it wins
Food and Drug Administration approval. Abbott Laboratories
and Japan's Takeda Chemical Industries, meanwhile, are preparing
to file for approval to market their pill treatment for male
erectile dysfunction, known as apomorphine.
Physicians at AUA conference will have a chance to review
the results of the latest studies of those pills, along with less-
convenient remedies made by competitors like Vivus Inc.'s Muse
and Pharmacia and UpJohn's Caverject.
Viagra-mania will overshadow the topics that usual dominate
the gathering of 18,000 urology specialists, like prostate
cancer, incontinence and an enlarged prostate condition known as
BPH.
1 Million Prescriptions
The market for impotence treatments took off last month when
Pfizer introduced Viagra as the first pill treatment for
impotence.
Reports of the drug's effectiveness have already prompted
some 1 million men to seek Viagra prescriptions from urologists,
internists and primary care physicians.
The drug is not for all patients, however, as it should not
be taken with nitrates, common drugs that dilate arteries in
patients with chest pain. That combination can lead to severely
lowered blood pressure, a heart attack, or death.
The FDA on Friday said at least six people have died while
taking Viagra, though it's not clear whether the deaths were
linked to the drug's use or whether they were treated with
nitrates.
To be sure, the FDA said it still considers Viagra safe
and effective, while investors said they don't think reports
of the deaths will hurt the drug's long-term sales. Analysts
estimate that Viagra sales will reach $2 billion next year, more
than 12 times the combined $158 million in revenue reported by
Vivus Inc.'s Muse and Pharmacia and UpJohn's Caverject.
Competing companies are counting on the interest generated
by Viagra to encourage more men to seek treatment for impotence,
increasing sales for other remedies as well, especially among men
whose heart medication makes it risky to use Viagra.
''When you've got a really big drug, people who never would
have gone to doctors start to do so,'' said Jerry Castellini, a
Loomis Sayles Inc. fund manager, whose $2.5 billion portfolio
holds about 700,000 Pfizer shares.
Impotence is a problem for as many as an estimated 30
million men in the U.S., including more than a third of 40-year-
olds and two-thirds of 70-year-olds. While surgery, vacuum pumps,
prostheses, penile injections and drug delivery through the
urethra have been available for years, they can be painful and
awkward to use, leaving many men reluctant to discuss the problem
with their doctors.
Physicians attending the meeting will be able to review the
results of late-stage clinical trials of two other pills for
impotence, TAP Holdings Inc.'s apomorphine and Zonagen Inc.'s
Vasomax. Those companies will include those studies when they
apply for FDA approval to market the drugs.
Vasomax will be marketed by Schering-Plough, one of
the world's biggest drugmakers. Apomorphine's developer TAP is
owned by two other giants in the pharmaceutical industry, Abbott
Park, Illinois-based Abbott Laboratories and Takeda Chemical
Industries Co. of Japan.
Vasomax has had its ups and downs. At least eight groups of
shareholders have filed lawsuits against Zonagen, frustrated by
delays in filing for FDA approval to market the drug. Meanwhile,
Zonagen shares have nearly doubled this year after the tiny
Houston-area company signed up Schering-Plough as its marketing
partner.
Zonagen plans to file a new drug application with the FDA by
the end of next month, while TAP has said it expects to seek
approval by the middle of next year.
Non-invasive treatments like Viagra, Zonagen, apomorphine
and topical creams will one day be able to treat about 80 percent
of men suffering from impotence, estimates Ira Sharlip, a member
of the American Urological Association's impotence guidelines
committee.
That leaves treatments like Vivus Inc.'s Muse, which was the
top-selling impotence product before Viagra's introduction, and
Pharmacia & Upjohn's Caverject injection slugging it out for the
rest of the market.
''These are men who have already come out of the closet and
said to their primary care physicians that they have this problem
and want to be treated for it. In the 20 percent of those people
it doesn't work for, they're going to say 'What are my
alternatives now?,''' Sharlip said.
Vivus is developing an improved version of Muse, its system
that inserts an alprostadil pellet in the urethra. The urology
meeting will hear the results of clinical trials of that product,
which seeks to boost the effectiveness of Muse by adding an alpha
blocker to the pellet.
Muse had sales of $108 million last year, more than double
the $47 million rung up by Caverject, according to IMS Health.
Muse's strongest challenge will come from Senetek
Plc's INVICORP, which will also be discussed at the conference,
Lisi said.
One interesting discussion on impotence treatments will take
place Sunday afternoon, when the Society for the Study of
Impotence meets to discuss whether they can be used to treat
sexual dysfunction in women.
''It's an important subject to address because if Viagra and
other products become effective and safe for treating female
dysfunction, you at least double the market,'' said Sharlip. It
could take several years to determine whether drugs like Viagra
are effective and safe in women, he said.
Prostate Treatments
Investors will also be closely watching results of studies
on two incontinence drugs -- Pharmacia & Upjohn Inc.'s Detrusitol
and Alza Corp.'s Ditropan XL.
And the conference will also review clinical trials of
treatments for symptomatic benign prostatic hyperplasia, or BPH,
a noncancerous enlargement of the prostate that restricts urine
flow.
Until the 1990s, the primary treatment for BPH was a
surgical procedure called a transurethral resection of the
prostate, which required general anesthetic, a hospital stay and
whose side effects could include bleeding and sexual dysfunction.
Now some 2 million men are on drug treatments that must be
taken daily for the rest of a patient's life, according to
Phillip Nalbone, an analyst at Volpe Brown Whelan. Those drugs
include Merck & Co.'s Proscar, Abbott Laboratories Inc.'s Hytrin
and Bristol-Myers Squibb Co.'s Cardura.
''There's a huge market opportunity out there, there's a
clear need for alternative to drug therapies and old surgical
standards,'' said Nalbone.
--Jim Finkle in the San Francisco newsroom (415) 912-2996 with |
