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


To: Zebra 365 who wrote (9217)6/5/1998 8:44:00 AM
From: regine  Read Replies (1) | Respond to of 23519
 
TO ALL! BETTER HOLD ON TO YOUR SHARES OR BUY NOW!!!

Friday June 5, 7:31 am Eastern Time

Company Press Release

VIVUS Responds to Reports of "Disappointing Results"
With MUSE

MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 5, 1998--VIVUS, Inc. (NASDAQ:VVUS -
news) today responded to media reports about ''disappointing results'' data presented
at the American Urological Association (AUA) annual meeting earlier this week in San
Diego, CA. VIVUS would like to refer patients and physicians to the efficacy data of
MUSE(R)(alprostadil) amassed from 71 worldwide clinical trial sites and involving nearly
1,800 patients. Additional new data on the efficacy of MUSE in clinical practice are
scheduled for presentation at the American Diabetes Association meeting to be held
June 13-16 in Chicago, IL.

The abstract presented at the AUA by researchers from Presbyterian Hospital in Dallas,
TX stated that ''only 27% of patients achieved rigidity sufficient for intercourse despite
being challenged to the highest dose.'' In discussing his study results, the presenting
physician clarified that not all men were challenged to the highest doses (500 or 1000
mcg) of MUSE, and that only 10 of these 115 patients (or 9%) were administered the
1000 mcg dose. In VIVUS' clinical trials of MUSE, between 41% and 65% of men
required the 1000 mcg dose to achieve rigidity sufficient for intercourse.

The efficacy of MUSE was established in part through the VIVUS Phase III clinical study
which was the basis of Food and Drug Administration (FDA) approval of MUSE in
November 1996. This 58-site U.S. study reported in the New England Journal of
Medicine in January 1997 found that 66% (996/1511) of men with severe, organic
erectile dysfunction were able to achieve an erection sufficient for intercourse in a clinic
setting. A more recent 13-site study of MUSE conducted in five European countries and
reported in this month's issue of the British Journal of Urology found that 64%
(159/249) of men with severe, organic erectile dysfunction achieved an erection
sufficient for intercourse in a clinic setting. Patients in these two VIVUS-sponsored clinical
studies received doses of MUSE up to and including the highest (1000 mcg) dose.
Currently, over 80% of all prescriptions for MUSE are at the 500 or 1000 mcg dose
level.

''Efficacy of MUSE is clearly dose dependent,'' said Tom Lue, MD, Professor of Urology,
University of California, San Francisco. ''In my clinical practice, most patients require
dosing of MUSE at the 500 or 1000 mcg level.''

Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic
systems for the treatment of erectile dysfunction, commonly referred to as impotence.
VIVUS has pioneered a novel therapy for erectile dysfunction known as
MUSE(R)(alprostadil). MUSE is a therapy which consists of a proprietary, non-invasive
drug delivery system applied into the urinary opening, and is not for men with sickle cell
trait, disease or other blood disorders. One third of men reported genital pain, causing
some to stop use. A few men reported dizziness and, rarely, fainting.

Note to Editors: MUSE is a registered trademark of VIVUS, Inc. Additional written
materials, recent releases and Company information are available through a variety of
sources, including: the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand
Service (1-888-329-5719).

Contact:

VIVUS
Nina W. Ferrari or David Yntema, 650/934-5200



To: Zebra 365 who wrote (9217)6/5/1998 9:21:00 AM
From: Frostman  Read Replies (1) | Respond to of 23519
 
Zebra, WSJ interactive picked up the story this morning as well..
**************************
Vivus: Efficacy Of Muse Impotence Pdt Is 'Dose Dependent'
Dow Jones Newswires

MOUNTAIN VIEW, Calif. -- Vivus Inc. (VVUS) said the efficacy of its impotence drug, Muse, is "dose dependent."

The company was responding to recent media reports about "disappointing results" presented by Dallas researchers at the American Urological Association annual meeting earlier this week.

In a press release Friday, Vivus said the data, which indicated that 27% of patients achieved rigidity sufficient for intercourse, were based on a study in which not all men were challenged to the highest doses (500 or 1,000 mcg) of Muse. The company said only 9% of the patients in the study received the 1,000-mcg dose.

Vivus said in its own trials, between 41% and 65% of men required the 1,000-mcg dose to achieve rigidity sufficient for intercourse....>>
etc etc.

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