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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: Tunica Albuginea who wrote (5917)3/16/1998 11:02:00 PM
From: BigKNY3  Read Replies (1) | Respond to of 23519
 
TA: I'm impressed! You included me in your Vivus Update. Your most balanced and informative update...ok, I'm biased.

Here's some additional information concerning the Vasomax study referred to by Edderd in this month's Journal of Urology. In this study, sponsored by Zonagen, efficacy was less than 40%.

Listed below is an editor's comments on the study.

Good investing!

BigKNY3
_______________________________

The Journal of Urology Vol. 159, April 1998, pg. 1216

ORAL PHENTOLAMINE AS TREATMENT FOR ERECTILE DYSFUNCTION

EDITORIAL COMMENT

Despite excellent results and minimal side effects, vasoactive intracavernosal pharmacotherapy of erectile dysfunction has poor patient acceptance and high discontinuation rates. Given the magnitude of the clinical problem, less invasive therapeutic approaches, in particular oral medication, demand attention, even if initial results may appear discouraging.

Patients for this prospective, double-blind, placebo controlled trial or oral phentolamine were carefully selected by an elaborate evaluation, which also included an interview by a psychiatrist, to avoid "obvious" psychogenic impotence. In addition, potential candidates were subjected to a placebo run-in period which resulted in exclusion of 10% of patients because of a positive response to placebo. Nevertheless, 20% of the patients in the placebo arm of the final study reported a successful response. In comparison 40% patients on active drug arms were considered to be responders, which is lower than reported previously in placebo controlled trials by Gwinup (reference explanation could be differences in drug preparation and/or dosage, although a clear dose/response relation was not unequivocally shown (success rates per total number of attempts at intercourse may bias the results by giving good individual responders more weight). More likely, patients with psychogenic disorders were excluded more vigorously.

Responders were younger and apparently had normal cavernous tissue and an intact autonomous supply. Is this treatment of psychogenic impotence or of early organogenic impotence, or a disguised placebo effect? As stated by the authors, the small number of patients does not permit a valid statistical analysis. Given the multiple variables that seem to influence outcome, even the statement that "oral phentolamine may be of benefit" must be viewed with caution. Only a similar study with patient populations large enough to permit valid statistical analysis will provide the answer. The authors' pleas for less stringent end points in defining success appears logical from a clinical standpoint. For determining the true benefit of a novel therapeutic approach the use of more subjective end points, such as satisfying intercourse, dilutes the protocol and hence automatically requires even larger patient numbers for meaningful results.

Michael Marberger
Urologische Klinik
Der Universitat Wien
Vienna, Austria



To: Tunica Albuginea who wrote (5917)3/17/1998 12:05:00 AM
From: east  Read Replies (1) | Respond to of 23519
 
TA thanks for the update, I enjoyed reading them...

What do the implication of a delay for viagra approval by FDA does to
VVUS stock price, which has a huge short interest, and is ready to explode?
Just a question...



To: Tunica Albuginea who wrote (5917)3/17/1998 8:06:00 AM
From: Lerasa  Read Replies (2) | Respond to of 23519
 
TA, what's your medical opinion of this abstract?

THE EFFECT OF THE SPECIFIC PHOSPHODIESTERASE (PDE) INHIBITORS ON HUMAN AND RABBIT CAVERNOUS TISSUE IN VITRO AND IN VIVO
CHRISTIAN G. STIEF,* STEFAN šCKERT, ARMIN J. BECKER, MICHAEL C. TRUSS AND UDO JONAS

From the Dept. of Urology, Medizinische Hochschule Hannover, Hannover, Germany

Purpose: Phosphodiesterases (PDE) are key enzymes in the regulation of the smooth muscle tone. Experimental studies showed PDE III and V-isoenzymes to play an important role in the smooth muscle tone regulation of corpus cavernosum. Recently, a specific PDE III-inhibitor (milrinone) and a PDE V-inhibitor (sildenafil) were introduced in clinical studies. An experimental study was done to examine a potential role of PDE-inhibitors in the treatment of erectile dysfunction.

Materials and Methods: In the organ bath, strips from human and rabbit corpus cavernosum were precontracted and increasing doses of PDE inhibitors were added. In patients with erectile dysfunction as well as in rabbits, intracavernous injections of milrinone were done.

Results: PDE-inhibitors dose-dependently relaxed human and rabbit corpus cavernosum strips. In the precontracted human cavernous tissue, milrinone and sildenafil were equally potent and efficacious in vitro. In the rabbit, milrinone induced slight tumescence but dramatic circulatory side effects. In patients, penile tumescences as well as full erections were observed.

Conclusions: Milrinone strongly relaxes human cavernous smooth muscle cells but it exhibits low relaxant effects in the rabbit cavernous tissue. In human tissue, sildenafil was equieffective with milrinone in vitro. In vivo, milrinone induced a good erectile response in humans but a poor erectile effect in rabbits. Our results support a possible potential for selective PDE-III and -V inhibitors in the treatment of impotence and give further evidence that the rabbit is an animal model of limited value to study the effects of drugs on cavernous smooth muscle tone regulation in vivo.

Key words: phosphodiesterase, smooth muscle, erectile dysfunction



To: Tunica Albuginea who wrote (5917)4/19/1999 2:44:00 AM
From: Tunica Albuginea  Read Replies (2) | Respond to of 23519
 
Hi Tunica: 4-19-99:UPDATED VIVUS NEWS & WORLD REPORT (gg):
============================================================

MISCELLANEOUS MEDICAL/INVESTMENT INFO FOR NEW VIVUS INVESTORS;
=============================================================

...\\\\|////
...\\ ~ ~ //
..( @ @ )
._oOOo_\_^__oOOo__


It's ok, VVUS, we all gotta be 40 someday.
Yes, and even more.
Frostman Oct 3 1997 : #531
Message 2352631

EDITORIAL

This initiates a series of future editorials on SI to keep current and potential Vivus investors abreast of the latest in Erectile Dysfunction therapy, as well as to give them a broad perspective of the past and future of the Ed field.
This editorial had been published regularly in 1997 -1998 until it was decided to suspend it in the spring of 1998 when Viagra was approved and there was a national " blind rush " to a " new salvation pill for ED ".
We decided to wait because we are very familiar with the usual sequence to the approval of any drug, which goes likes this:
1st phase : This pill cures everything including old age. ( in this phase, patients are usually oblivious to cautionary statements, and " they must have the pill ". We prudently decided to lay low).
The 2nd phase ( as the pill is widely used and the true extent of potential ill-effects becomes known ): " this pill has too many side effects. Let's drop it "

I believe we started to enter this phase when th e FDA relabeled Viagra as follows:
verity.fda.gov

"Special Warnings:

<Viagra> was not studied in patients ( now you tell us ) who have a history of the following conditions:
oHeart attack, stroke, or life-threatening irregular heart rhythm within the last 6 months
oVery low and very high blood pressure
oHeart failure or unstable chest pain
oCertain eye disorders
Because of the blood pressure lowering effect of <Viagra>, your doctor will evaluate your overall medical condition to determine if this, in combination with sexual activity, could adversely affect you.

<Viagra> may cause a rare but serious condition of prolonged erection (priapism). It is important to contact your health care provider immediately if your erection lasts longer than 4 hours.

Men for whom sexual activity is inadvisable may not be good candidates for <Viagra>.

General Precautions with <Viagra>:

You should have a complete medical history and exam to determine the cause of your impotence before taking <Viagra>.
Men who have medical conditions that may cause a sustained erection such as sickle cell anemia, leukemia or multiple myeloma or who have an abnormally shaped penis may not be able to take <Viagra>.
There are several medications that are known to interact with <Viagra>, so be sure to tell your doctor about all medications you are taking including those you can get without a prescription.
<Viagra> has not been studied with other treatments for impotence, so use in combination with other treatments is not recommended.

As bewildered patients and hurried ( to the golf course ) physicians started reading the fine print it suddenly dawned on them that the FDA was talking about them and that they were about to start taking a pill that could kill them.
And the previously 160 + deaths reported now were rumored to be 436+
boards.go.com

And all of a sudden people started developing cold feet. First quietly and then like a thunder, when Pfizer last April 15, disclosed that US Viagra sales were drawing to a crawl:
"sales peaked within two months and then plateaued as pent-up demand was met,"
and
safety concerns arose over scores of deaths among users "
. ''Pfizer's stock is getting punished today, and it basically comes down to Viagra. It's not doing as well as last year's initial hype
suggested,'' said Mike Krensavage, an analyst for Brown Brothers Harriman & Co.
biz.yahoo.com

At the same time however Vivus came out with a better than expected eps report through early payment by it's European partner ASTRAZENECA and Janssen Pharmaceutica through licensing and distribution agreements. biz.yahoo.com
What made this exciting is that ASTRA-ZENECA have just merged to become the worlds THIRD largest Pharmaceutical Co behind Merck and Glaxo, and the 2nd biggest in the US behind Merck news.bioresearchonline.com
This, together with the great studies produced by Vivus at the AUA meeting and the forthcoming approval of Alibra which will be the MOST powerful ED drug ever, has now added credence to the Companies' plan to become the world's premier ED drug Co.

Even as thst occurs, Pfizer/Viagra the competition, is further being hammered by the forthcoming announcement due out by the FDA that will tell us the exact No of deaths.
These deaths were calculated by me in June 97 ( when the first ere reported) to occur at a frequency of about 3 - 4 a week. So that 88 weeks later, 88X3= about 264 - 362 deaths, a pretty high number.

Whether the deaths are 264 or 362 or 436, all those are pretty high numbers if you consider that POSICOR by ROCHE was with drawn after 1.5-2 years after only about 220 deaths: Message 4779642

And so this begins a new chapter for Vivus.

It is difficult to say when somebody should buy Vivus. But investors should always remember that " you buy when nobody wants it " in the famous words of Bernard Baruch. And " that it is always dark before the dawn ".

Is this the dawn? : equities.barchart.com

TA

Reference: Last Vivus Editorial, 3-16-98:
Message 3731994

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

A))) RECENT MEDICAL ARTICLES ON VIVUS/MUSE:
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

1)from the forhtcoming 5/99 American Urological meeting:

a} Does Renewed Sexual Activity Increase Cardiac Morbidity? Meta-Analysis of the
Experience With MUSE® (Alprostadil) : Answer:
auanet.org
b} Gene therapy for ED. A Vivus study. (Vivus at the forefront of ED research; gg Vivus ).

First study : auanet.org
Second study : auanet.org

c } Induction of Penile Erection by Intracavernosal and Transurethral Administration of
Zaprinast
and Prostaglandin auanet.org

d } EFFECTIVENESS OF COMBINATION THERAPY OF MUSE AND VIAGRA IN THE
SALVAGE OF ERECTILE DYSFUNCTION PATIENTS DESIRING NONINVASIVE
THERAPY auanet.org

[PS Do not forget this important, landmark, abstract in last year's AUA meeeting: This is Vivus' new magnum bullett - drug! ]
( GREATER )Efficacy Of Transurethral Alprostadil (MUSE®) VS. Transurethral
Alprostadil/Prazosin (AlibraTM) In Men with Complete, Organic Erectile Dysfunction
vivus.com



B)) OLDER SCIENTIFIC ARTICLES ON MUSE/VIVUS:
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
( Courtesy of VLAD ) : Message 8441310

C)) )The VIVUS COMPETITION :
XXXXXXXXXXXXXXXXXXXXXXX
VIAGRA:
April 1999 : Sildenafil (Viagra) and Ophthalmology
Editorial, by Michael F. Marmor, MD, Professor, Dept. of
Ophthalmology ,
Stanford University.
ama-assn.org

Older ( but still valid ), articles on VIAGRA side effects
Tunica, March 16, 1998 -Phosphodiesterase ( PDE ) sideeffects from Goodman &
Gillman 1996 ED.Textbook of pharmacology.
www3.techstocks.com
www3.techstocks.com
July 5, 1998 Message 5100265

D)))TECHNICAL ANALYSIS
XXXXXXXXXXXXXXXXXXX
Equities by Barchart.com : " Vivus, a Buy ".
www3.techstocks.com
equities.barchart.com

VIVUS INC

Symbol: VVUS Exchange: NASDAQ Quick Links: Quote / Chart

Date Open High Low Last Change Volume
04/16/99 6.00 6.00 5.00 5.03 +0.53 7645500


Composite Indicators
Trend Spotter (tm) buy

Short Term Indicators
7 Day Directional Indicators buy
10 - 8 Moving Average Hilo Channel buy
Price vs. 20 Day Moving Average buy
20 - 50 Day MACD Oscillator buy
20 Day Bollinger Bands buy
--- ---- ----
short term indicators average - 100% buy

Medium Term Indicators
40 Day Commodity Channel Index buy
Price vs. 50 Day Moving Average buy
20 - 100 Day MACD Oscillator buy
50 Day Parabolic Time/Price buy
--- ---- ----
medium term indicators average - 100% buy

Long Term Indicators
60 Day Commodity Channel Index buy
Price vs. 100 Day Moving Average buy
50 - 100 Day MACD Oscillator buy
--- ---- ----
long term indicators average - 100% buy

Overall Indicators Average - 100% buy


E)))INSTITUTIONAL holdings of VIVUS:
XXXXXXXXXXXXXXXXXXXXXX
Message 8458764

F))))BIGGEST MUTUAL FUND HOLDINGS OF VIVUS:
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Message 8458807

G)))PATENTS:
XXXXXXXXXX

1)ALIBRA PATENT:
Message 8512358

2)FEMALE ED PATENT:
Message 8200535

H)))THE FUTURE!!!!

Check out new study Vivus is preparing in Italy with DrGreco Ermanno:
( Higher target standards than the previous 2 pound study will be used this time.( Reportedly it will be a Lamborghini)
Message 3311743

TA