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 )


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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.

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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.

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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.

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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.

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ICOS. Headquartered in
Indianapolis, Ind. 151, 54-61,
January 1994 and World Population Projection Program Of United Nations (2002
Revision) with indirect standardization.20.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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 .

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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.

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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.

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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.

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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.

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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.

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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.

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(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 .

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