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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Dowscanner who wrote (5329)2/6/1998 12:39:00 AM
From: Rubble  Read Replies (2) of 23519
 
I've been waiting to buy some more VVUS for weeks, and finally decided to pick some up at today's low. It's been so odd how VVUS got stuck in this 15-15.1 range for what seemed like an eternity. The drop to 14 looked like a good opportunity. So, I turn on Nightline to see that the assault on Clinton is now heating up as his personal secretary is giving not that glowing testimony about him. I expect the market tomorrow will be considerably down early in the day, with the chance of a recovery later on as the White House gives rebuttals and the whole situation becomes shrouded in confusion once again. QCOM's announcement was already making me jittery about the INTC I picked up today...and now this.

Here's a couple articles I came across. The first talks a bit about VVUS' roots, and the second is about VVUS advertising campaign. I never knew that Virgil was experimenting on his own pecker to perfect MUSE...I bet few of you knew either :)

The Guardian

Tuesday, February 3, 1998

The Guardian Feature Page

Health: Up, up and away At the age of 73 an American doctor is launching the
new impotence treatment he developed by testing it - very thoroughly - on
himself. Annabel Ferriman reports
ANNABEL FERRIMAN

I suspected that I was lunching with someone unusual when my
guest, Dr Virgil Place, ordered hot water as an aperitif and then
insisted on eating his meal in reverse order, starting with
chocolate mousse and ending with soup. 'I am 73 years old,' he
said. 'Life is uncertain - eat dessert first.' But then what can
you expect from a man who invented a new treatment for male

impotence (now called erectile dysfunction, or ED) at the age of
64, tested it extensively on himself and launched it on the
American market at the age of 72? Since then almost 500,000 men
have tried it, and now it is to be launched in Britain, where one
in 10 men suffers from erectile dysfunction. What's different about
Dr Place's solution is the delivery system. In the 1980s, a doctor
in Sweden discovered that a drug called alprostadil, which was used
to dilate the blood vessels in new born babies with heart problems,
was also highly effective in penile erectile tissue. It was taken
up and marketed by the pharmaceutical industry, but the only way of
using the drug was by injection, direct into the side of the penis.

'This was not a user-friendly system,' explained Dr Place, an
American who is both an endocrinologist (hormone specialist) and a
drugs industry pharmacologist. Place should know. He used the old
method of treatment after suffering erectile dysfunction following
an operation for prostate cancer in 1988. He set about trying to
discover a better method of getting the drug into the blood vessels
of the penis. He was well qualified, because he had spent the
previous 20 years developing new drug delivery systems, including
trans-dermal skin patches to deliver drugs for motion sickness,

high blood pressure, angina and menopausal symptoms in women. He
had also developed a testosterone skin patch for men.

By 1989 he felt he had come up with a solution. He had developed
a system in which patients could insert a small pellet into the
opening of the urethra (the tube in the penis through which urine
is passed) and massage it until it dissolved. The patient has to
have urinated shortly before inserting the pellet because the drug
needs a few drops of urine to act as a solvent. The drug works
within five to 10 minutes and the erection usually lasts between 30
minutes and an hour.

During his time in the pharmaceutical industry, Dr Place had
always tried out new inventions on himself before proceeding to
clinical trials. As he puts it, all new systems are first tried 'in
vitro' (in test tubes), next 'in vivo' (in animals), and then 'in
Virgil'. This new system was no exception.

'I worked on it every evening and at weekends, changing the
formulation, testing it and then modifying and improving it,' he
told me at our lunchtime discussion, which was followed closely by

diners at the adjoining tables. By the end of the eighties he felt
that he had got it right. Unfortunately the company he was with was
not interested in it, so in 1991 he left and, with venture capital
from several groups in California, formed Vivus Inc. The company
set up several large clinical trials and, after satisfactory
results (a successful trial was published in the New England
Journal of Medicine), applied to the Food and Drug Administration
for a licence, which they received in November 1996. The system,
named Muse (Medicated Urethral System for Erection), went on to to
the market in the US in January 1997.

So does the system, which has several advantages over an
injection, have any disadvantages? Putting the applicator into the
urethra is not as uncomfortable as it sounds, apparently: the tube
is three millimetres in diameter and has to be inserted three
centimetres. But in some cases, the drug does not disperse well,
with the result that patients feel some uncomfortable stinging in
the penis. Most problems, says Place, are surmountable. 'We want
to see patients educated properly in its use. We have discovered in
the US that if a doctor simply prescribes it and does not train the
patient properly, he often does not come back for more. But doctors

who educate their patients get success rates of 60 per cent or
more.' In the US the company has a free help-line which, in the
first weeks after the drug's launch, got about 1,000 calls a day.
It is staffed by male nurses, who sometimes have to talk the
procedure through with the patient. Some callers listen to the
instructions with the receiver in one hand and their reproductive
equipment in the other.

Until the 1980s doctors thought that psychological problems were
the main cause of impotence, but many now believe that
physiological reasons may account for about three-quarters of
cases. The condition also increases sharply with age. About 5 per
cent of 40-year-olds are affected and this goes up to 15-25 per
cent of men over the age of 65.

Despite the fact that Dr Place is 73 and has undergone major
prostate cancer surgery, he is still carrying out research into
male and female dysfunction. He and his third wife, Irina, a
beautiful 30-year-old English literature PhD student have a home in
Hawaii and, when he is not working, ski-ing or travelling the
world, they are developing a botanic garden in their 45-acre

estate. Perhaps we should all adopt Dr Place's recipe for health,
success and long-life and drink only hot water at all times and
start meals with a chocolate dessert.



The Business Journal - San Jose

Monday, February 2, 1998

Vol. 15, Issue: 41

Rejection of Super Bowl ad deflates Vivus' plans Goal was for 30-second spot to
anchor campaign
Peter Delevett Business Journal staff writer

If you were among the millions who watched this year's Super Bowl,
you probably saw advertisements for Silicon Valley companies
including Oracle Corp., Intel Corp. and Sun Microsystems Inc.

But you didn't see one for Vivus Inc. of Mountain View.

Officials at the medical technology company said NBC turned down

its request for fear that viewers weren't ready to see a TV ad for
an erectile-dysfunction product.

Vivus had envisioned a 30-second Super Bowl spot as the
centerpiece of a major advertising campaign kicked off in recent
weeks to promote Muse, a medication that increases penile blood flow.

"It was disappointing that NBC made this decision," said Julian
Gangolli, Vivus' vice president of sales and marketing.

Company officials said the Super Bowl would have been a perfect
forum for discussing impotence, which they said affects one in 10
men by age 50.

The company's research shows men of that demographic constitute 75
percent of the Super Bowl audience.

The advertisement consists solely of text with a voice-over by
actor Ed Asner. It starts off with the words: "Attention, impotent
men-all 20 million of you."

It goes on to urge men to discuss Vivus' product with a doctor,
"then buy some flowers."

The advertisement apparently was a bit too much for NBC, even
without any visual accompaniment.

NBC turned down Vivus and its proffered $1.3 million check because
the ad didn't pass the network's litmus test for propriety,
according to Leslie Clayton of San Francisco ad agency
Hoffmanewis, which created the spot.

Ms. Clayton said Rick Gitter of NBC's standards committee told
Hoffmanewis the network would consider running the ad only after
11:30 p.m.

"Since there was no experience airing something like this, they
said, 'We really want to wait until it's on television [elsewhere]
before we put it on prime time," she said.

Vivus appealed the decision to Roz Weinman, NBC's senior vice
president for broadcast standards, to no avail.

Mr. Gitter was traveling and unavailable for comment. Ms. Weinman
did not return phone calls. Both are based at NBC's New York
headquarters.

But Alex Constantinople, NBC's director of corporate
communications, did say: "We're not comfortable airing the ad,
bottom line."

Vivus called the network's decision ironic, pointing out that
NBC's own sitcoms are more risque than the proposed ad. Ms.
Constantinople said separate departments set standards for the
content of ads and programs.

NBC's competitors apparently don't share its concerns about
viewer reaction.

Ms. Clayton said CBS had agreed to air the commercial during the
AT&T Pebble Beach National Pro-Am golf tournament Jan. 31. The ad
also was scheduled to run during the "CBS Evening News with Dan
Rather," "60 Minutes," "Chicago Hope" and others.

ABC has agreed to air the ad after 10 p.m., a constraint Vivus
can live with because it includes programs such as "20/20," Ms.
Clayton said.

"Obviously, it's subjective," Ms. Constantinople said when asked
why other networks would agree to run the spot.

A CBS spokesman who requested anonymity said networks must be
careful in deciding whether to run certain ads, and when.

"Every town has different mores," he noted. "What goes in New
York may not go in Eau Claire, Wis., or Oxford, Miss."

He added that in general, a product such as Muse would be
restricted to post-10 p.m. advertising.

Ms. Clayton said CBS has agreed to run the spot earlier during
specific programs.

Print ads for Muse will appear in mainstream publications such as

Newsweek, Time, Readers Digest and The New York Times.

"I would venture to guess that in three months, [NBC] will be
looking for us to advertise," Ms. Clayton said.

Mr. Gangolli of Vivus said the company hopes the ad blitz will
debunk notions that impotence is primarily a psychological
condition. He said research has shown 90 percent of cases are
attributable to physical causes such as diabetes, vascular surgery
and hypertension.

But fewer than 10 percent of men who suffer from impotence seek
treatment, Mr. Gangolli said.

"We hope this [advertising] effort will let individuals know they
are not alone, that impotence can be easily treated," he said.

More than 475,000 patients have used Muse since it was launched
in early 1997, making it the nation's top-selling product for
impotence treatment, according to Vivus.

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