05), in the
group of
women who received at least one dose each of placebo and active drug."
About
ALISTA
ALISTA is an investigational proprietary formulation of alprostadil
applied locally
to the female genitalia in Phase 3 clinical trials. The subgroup discussed here
included 155 patients
, mean age 65, who had significant comorbid conditions;
many of these patients also had severe ED
at baseline (51.
"Cialis provides a meaningful therapeutic benefit with regards to erectile
function
in men suffering from ED and significant comorbid conditions," said
Sanjeev Ahuja, M.
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq: ICOS)
and Eli Lilly and Company (NYSE: LLY), developed tadalafil for the treatment
of erectile dysfunction
.
(6) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou DG,
Krane RJ.newscom
.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )
mcsweeney edell
This
subgroup comprised patients who met the
enrollment criteria for the MOMENTUS
trial but who could not be included in any other predefined
group.4 percent of patients reported an improvement in their
erections after taking Cialis 20 mg
based on the Global Assessment Questions
(GAQ)(2), question one (Has the treatment you've been taking
during this study
improved your erections?).
Discontinuations due to adverse events in this group
were three percent and
similar to previously reported discontinuation rates in Cialis clinical
trials
.1%
Hyperlipidemia (%) 49.1%
MULTIPLE COMORBIDITIES:
Have two or more comorbid conditions 84.
(3) The IIEF is a validated
scale that assesses erectile function by
measuring treatment-related responses in patients.mcsweeney erectile
About VIVUS
VIVUS, Inc. is a pioneer in the research and development of proprietary
products
to restore sexual function for women and men. For women, VIVUS has initiated its Phase 3 programs with
ALISTA(TM) (topical alprostadil) for female sexual arousal disorder, and
Evamist(TM) (estradiol
MDTS) for the alleviation of menopausal symptoms.com. "Men
who have ED should visit their doctor
to discuss their sexual health and their
overall health."
The most commonly reported side
effects in the patients in this group were
headache, flushing, nasal congestion, back pain, and upset
stomach. More specifically, there can be no assurance that Cialis will
achieve commercial success
or that competing products will not pre-empt market
opportunities that might exist for the product
. Vol.
(8) Diseases and Conditions: Impotence,
http://www.improves furchgott
VIVUS currently markets
MUSE
(R) (alprostadil) suppository in the U. and internationally through
distributors for the treatment
of erectile dysfunction. Additional
information about ICOS is available at http://www., Lilly provides
answers -- through medicines and
information - for some of the world's most urgent medical needs
. Investors are cautioned that matters subject to forward-looking
statements involve risks and uncertainties
, including economic, competitive,
governmental, technological, legal and other factors discussed
in the two
companies' respective filings with the Securities and Exchange Commission,
which may
affect the business and prospects of the two companies and Lilly
ICOS. 170, 353-358; August 2003
(5) The SEP diaries contain five patient diary questions that allow
patients to record responses
following sexual events.flaws nyu
The disorder is characterized by diminished
blood flow to the genital tissues
resulting in a lack of genital engorgement
and a reduction in pleasure and sensation during sexual
stimulation.2
COMORBID CONDITIONS:
Diabetes (%)
72. Experts believe that 80 - 90 percent of ED cases are
related to a physical or medical condition
, like diabetes, cardiovascular
diseases, and prostate cancer treatment, while 10 - 20 percent are
due to
psychological causes(7,8). Such a
combination could cause a sudden, unsafe drop in blood
pressure.cialis.
ICOS Corporation, a biotechnology company headquartered in Bothell,
Washington
, is dedicated to bringing innovative therapeutics to patients.
(7) Shabsigh, R.scrotal impotence
ICOS. Headquartered
in
Indianapolis, Ind. 151, 54-61,
January 1994 and World Population Projection Program Of United
Nations (2002
Revision) with indirect standardization.20.cons erectile
These
statements may be identified
by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimated" and
"intend," among others.9. Not included in this clinical trial were patients with certain
serious
underlying cardiovascular conditions, including recent myocardial
infarction, uncontrolled arrhythmias
, hypotension (<90/50 mm Hg), uncontrolled
hypertension (>170/100 mm Hg), unstable angina or angina
occurring during
sexual intercourse, or those who recently suffered a stroke or had severe
heart
failure. Cialis does not protect a man or his partner from sexually
transmitted diseases, including
HIV.
P-LLY
Except for historical information contained herein, this press release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform
Act of 1995.seats talkessel
Investors should read the
risk factors set forth in VIVUS' Form 10-K for the year ended
December 31,
2004 and periodic reports filed with the Securities and Exchange Commission. It is
exciting to see such positive results in this group of patients, who had a
relatively high degree
of severe ED and many of whom had multiple
comorbidities," said Irwin Goldstein, M. Also, these
patients tolerated
treatment with Cialis very well. They also showed a 7. In many cases, however
, both psychological and
physical factors contribute to the condition(9).impotence.bicyclists improves
There are a number
of factors that
could cause actual events to differ materially from those indicated by such
forward
-looking statements. On average, nearly
50 percent of all attempts resulted in an erection that lasted
long enough to
have successful sexual intercourse when patients were treated with Cialis 20
mg
.
After taking Cialis 20 mg, patients reported an increase from baseline in
erections that
resulted in "successful sexual intercourse" based on positive
per patient response to Sexual Encounter
Profile (SEP)(5) question three (Did
your erection last long enough for you to have successful sexual
intercourse?). This will give their doctor the opportunity to do a complete
exam, during which
significant health problems may be detected and addressed,
and treatment options for ED can be discussed
.
Men should discuss their medical conditions and medications, including
alpha blockers for
prostate problems or high blood pressure, with their
doctors to ensure Cialis is right for them and
that they are healthy enough
for sexual activity. ICOS is working to develop treatments
for serious
unmet medical conditions such as benign prostatic hyperplasia,
pulmonary arterial hypertension, cancer
and inflammatory diseases.org/FAQ/index.abnormalities cycler
VIVUS Announces Presentation of ALISTA(TM) Clinical Data for
the Treatment of Female Sexual Arousal Disorder
This was the first trial that evaluated the use
of ALISTA in premenopausal women in the home setting. Costabile. Cialis studies were not designed
to assess
multiple intercourse attempts after a single dose.edell cycler
No serious adverse
events were reported
during this study. "ALISTA
represents a promising new treatment approach for those women who suffer
from
FSAD.
ALISTA is non-hormonal and is believed to increase blood flow to the female
genitalia
, thereby promoting engorgement and other natural processes that
occur during sexual stimulation.
VIVUS' current product
pipeline includes four investigational products in late stage clinical
development
.
CONTACT: Christina Weisgerber of VIVUS, Inc. These data will be presented today at the
100th Annual
Meeting of the American Urological Association (AUA).9 percent).com .
(1
) Cialis(R) is a registered trademark of Lilly ICOS LLC. Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy.abnormalities prostatitis
The study showed that 64 percent of ALISTA doses resulted in
satisfactory sexual events
when compared to placebo (p<0. For men, VIVUS is developing avanafil for erectile
dysfunction, which
is currently in a Phase 2 program. These comorbidities include cardiovascular disease
(including
hypertension), diabetes, depression, hyperlipidemia, and prostate
disease (including those who had
undergone prostatectomy).
"Treatment of ED in men with comorbid conditions is a challenge.
ICOS
is marketing its product, Cialis (tadalafil), through Lilly ICOS LLC, for
the treatment of erectile
dysfunction. (2002).impotence goldstein
Raymond A. As with any pharmaceutical under
development, there are significant
risks in the development, regulatory
approval and commercialization of new products. "The findings
confirm
that Cialis improved erectile function in men with ED even when associated
with significant
comorbid conditions.
In the subgroup, 77.4 percent) of the attempts
resulted in an erection
that lasted long enough for successful sexual
intercourse, compared to the percentage at baseline
of 16.D.
Baseline Characteristics Study group
AGE:
Mean age (years) 65
ED SEVERITY:
Severe
ED (%) 51.5%
About ED
ED is defined as the
consistent inability to attain and maintain an
erection sufficient for sexual intercourse.
Cialis is available by prescription only and is not for everyone. For full patient
information
, visit http://www.asp. Data accessed 11.paying flaws
Alprostadil is a synthetic version of prostaglandin E1
(PGE1), a naturally
occurring vasodilating agent. With both issued and pending patents, the
Company
believes it has the dominant patent position for the local delivery of
prostaglandins, such as alprostadil
, for the treatment of women with Female
Sexual Arousal Disorder (FSAD). VIVUS does not undertake
an obligation to
update or revise any forward-looking statement., +1-650-934-5240
5 million
patients worldwide have been treated
with Cialis since its first introduction in February 2003.edell scrotum
Costabile
, the Jay Y. It is the same active ingredient found in
VIVUS' product MUSE(R), which is used to treat
male erectile dysfunction."
Study Design + Key Findings
The MOMENTUS study (Multiple
Observations in Men with ED in National
Tadalafil Study in the United States) is a multi-center,
open-label study that
evaluated the efficacy and safety of Cialis 20 mg in 1,911 American men with
ED who were enrolled into eight predefined groups.48 in the Erectile Function (EF) Domain Score of
the
International Index of Erectile Function (IIEF)(3). Cialis is widely available throughout the
world,
including Australia, Brazil, Mexico, Canada, the United States and countries
throughout
Europe. Although rare, men who
experience an erection for more than four hours (priapism) should
seek
immediate medical attention. Impotence and its Medical and Psychosocial Correlates: Results
of
the Massachusetts Male Aging Study, Journal of Urology.dysfunction bicyclists
Testosterone MDTS(R) for the treatment
of hypoactive sexual desire disorder
has completed Phase 2 development. The MDTS system is a patented
new-generation, transdermal drug delivery technology that delivers drugs
through the skin. For
more information
on clinical trials and products, please visit the Company's web site at
http:
//www.
These forward-looking statements are based on VIVUS' current expectations and
actual results
could differ materially.8%
Depression (%) 38. More than
4. Erectile Dysfunction.bicyclists seats
05). There are no guarantees that
future clinical studies discussed in this
press release will be successful or
that any product will receive regulatory approval for any indication
or prove
to be commercially successful. Men
taking nitrates, often used for chest pain, should
not take Cialis.
Lilly, a leading innovation-driven corporation is developing a growing
portfolio
of first-in-class and best-in-class pharmaceutical products by
applying the latest research from
its own worldwide laboratories and from
collaborations with eminent scientific organizations.erectile webmd
ED
affects an estimated 189
million men worldwide(6). Patients with certain medical
conditions or
taking concomitant medications may need to start at a lower
dose. N Engl J Med 2000; 342: 1802-1813
.flaws scrotal
The use
of ALISTA also resulted in significant improvement in orgasm as measured by
the increase
in the number of events that resulted in orgasm (p<0.
"Female sexual arousal disorder is a common
condition that has the
potential to significantly damage relationships," said Dr."
"We are
pleased to present these data for the first time at the American
Urological Association's Annual
Meeting," commented Leland F.vivus.
Study Population
The table below depicts the baseline
characteristics of age, severity of
ED, and comorbid conditions among this subgroup of patients.
(4) Mulhall J.bicycling seats
Study Shows Premenopausal Women Treated With ALISTA Experienced a Significant
Increase in Satisfactory Sexual Events
SAN ANTONIO, VIVUS, Inc.
Certain statements in this press release are forward-looking within the
meaning of the Private
Securities Litigation Reform Act of 1995. These factors include, but are not limited to,
substantial
competition; uncertainties of patent protection and litigation;
reliance on sole source suppliers;
limited sales and marketing efforts and
dependence upon third parties; risks related to the development
of innovative
products; and risks related to failure to obtain FDA clearances or approvals
and
noncompliance with FDA regulations. This is compared to approximately 17 percent of attempts at baseline
for
this patient group. It is generally
considered that an improvement of four points or more
in the EF domain score
reflects a clinically meaningful change(4). Results and the timing and outcome
of events may differ materially from
those expressed or implied by the forward-looking statements
in this press
release. Vol. New York: Kensington.paying seats
Dr. Gillenwater Professor of Urology and
Vice Chairman of the Urology Department at the University of Virginia Health
System Charlottesville
, VA, presented a detailed analysis of previously
announced results of the study. Wilson, VIVUS'
President
and Chief Executive Officer.D., Professor of Urology and
Gynecology at the Boston University School
of Medicine. In this study, after a
four-week treatment-free period to determine baseline ED, patients
were
instructed to take Cialis 20 mg as needed prior to sexual activity (not more
than one dose
a day) for a period of 12 weeks.9%
IIEF EF Domain Score 12.6
percent of patients had hypertension 67.03
(9) Lue, Tom F.seats scrotum
05) and by
the increase in
the orgasm domain score of the Female Sexual Function Index
(FSFI) questionnaire (p<0. The standard
recommended starting dose
of Cialis for most patients is 10 mg.
(2) The GAQ is a self-administered
questionnaire that allows patients to
rate improvement in erections.mcsweeney seats
S.Clinical Data Shows Lilly ICOS
' Cialis(R) (tadalafil) Improves Erectile Function in ED Patients with Significant Multiple Comorbid
Conditions
SAN ANTONIO, Texas, Lilly ICOS LLC
(NYSE: LLY and Nasdaq: ICOS) announced data
today from an open-label clinical
trial showing Cialis(R) (tadalafil)(1) improved erections in more
than three-
quarters of men who were suffering from erectile dysfunction (ED) and one or
more
comorbid conditions.3%
Cardiovascular disease* (%)
*60. Such forward-looking
statements are
based on current expectations, estimates and projections about the industry,
management
beliefs and certain assumptions made by the management of ICOS and
Lilly.paying cons
FSAD is one of the most
common sexual
problems experienced by women.6 point improvement from the
baseline score of 11
. The most common side effects with Cialis were headache,
upset stomach, delayed backache or muscle
ache.lilly. Deciphering Erectile Dysfunction Drug Trials, Journal of
Urology.
(Logo:
http://www.cycler impotence
(Nasdaq: VVUS)
today announced that positive results of a Phase 2 clinical study evaluating
the safety and efficacy of ALISTA(TM) (topical alprostadil), an
investigational treatment for
Female Sexual Arousal Disorder (FSAD), in
premenopausal women were presented at the Annual Meeting
of the American
Urological Association (AUA) in San Antonio, Texas. The double blind, placebo-controlled
,
crossover-design trial evaluated the response to ALISTA administered at home
by 51 women. "The
urology community has been at the
forefront of advancing the research and understanding of female
sexual
dysfunction, and we continue to work together with thought leaders in this
field for the
Phase 3 development of ALISTA for FSAD. On average, nearly half (49., Associate Medical Director, Eli
Lilly and Company.0%
Benign Prostatic
Hyperplasia/Prostatectomy (%)
36.
About Cialis
Cialis was approved by the FDA in November 2003 for the
treatment of
erectile dysfunction. Men should not drink alcohol in excess with
Cialis.
Individual results may vary.com. Additional
information about Lilly is available at http://www
.com .scrotum flaws
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