Cialis
Information, News and Articles
The following
represent a comprehensive list of articles that address the use
of Cialis for erectile dysfunction:
New Cialis Study Shows Significantly Enhanced
Sexual Function in 81 Percent of Men With ED Regardless of Severity.
Business Wire
March 19, 2001
'Marathon
Effect' of Impotence Drug
BBC News
August, 2002
New
Phase III Study Shows, Cialis -- IC351 -- 20 mg Improved Erections
in 85 Percent of Men With Erectile Dysfunction Regardless of ED
Severity.
Business Wire
June 14, 2001
New
Clinical Data Show Patients Receiving Cialis - tadalafil - Improved
Intercourse Success at 24 and 36 Hours After Dosing.
Business Wire
May 25, 2002
In
Two New Studies, Cialis -IC351- Provided an Extended Period of
Responsiveness in Men With Erectile Dysfunction.
Business Wire
May 1, 2001
First
Phase 3 Data Show Cialis -IC351- Improved Sexual Function in Men
With Difficult to Treat, Diabetes-related ED.
Business Wire
April 6, 2001
EAU:
Cialis (IC351) Improves Sexual Function In Diabetic Men With Erectile
Dysfunction
Doctor's Guide
April 6, 2001
Lilly,
Bayer Ready Drugs to Take On Pfizer's Viagra
WALL STREET JOURNAL
July 24, 2001
A
Longer Lasting Viagra? Eli Lilly/Icos Developing a Longer Lasting
Competitor to Pfizer's Viagra
ABCnews.com
June, 2002
Pfizer
fears rivals' potency Viagra, the impotence treatment, has made
millions, but two new drugs could spoil the fun
The Guardian
October 24, 2002
FDA
Accepts Cialis NDA
Business Wire
August 31, 2001
New Cialis Study Shows Significantly Enhanced Sexual
Function in 81 Percent of Men With ED Regardless of Severity.
Business Wire
March 19, 2001
Men with mild-to-severe erectile dysfunction (ED)
may benefit from Cialis(TM) (IC351), an investigational oral treatment
for ED, according to a study published in the latest issue of
International Journal of Impotence Research. This first-time publication
of detailed Phase II data in a peer-reviewed journal shows that
on-demand treatment with Cialis, an advanced phosphodiesterase
type 5 (PDE5) inhibitor, improved erections in 81 percent of men
(relative to placebo: 17 percent), regardless of severity. Cialis
is currently in global Phase III studies.
"Cialis is a potent and highly selective
PDE5 inhibitor that both increased sexual function and was well-tolerated
in a broad range of men with ED," said Harin Padma-Nathan,
M.D., clinical professor of urology at the University of Southern
California, Los Angeles, and lead investigator on the study. "Based
on these data, Cialis has the potential to become a new treatment
option for ED."
In the trial, up to 80 percent of patients with
severe ED and up to 90 percent of patients with moderate ED reported
significant improvement in their ability to attain and maintain
an erection. Additionally, Cialis increased the percentage of
successful and satisfying intercourse attempts for both men and
their partners. "One of the most encouraging signs was that,
as evidenced by the IIEF score, a substantial number of men who
took Cialis were returned to normal sexual function," said
Padma-Nathan.
Cialis Increased Erectile Function in On-Demand
Study
In this study, 179 men (mean age: 56 years) with
mild-to-severe ED were randomized to receive placebo or Cialis
at doses up to 25 mg taken on-demand over a three-week period.
The men in the trial agreed to attempt at least four sexual encounters
during the treatment period.
Several measures were used to assess Cialis in
a natural setting. Researchers compared baseline scores from the
International Index of Erectile Function (IIEF) questionnaire
(an important outcome measure reflecting overall erectile function),
sexual encounter profile diaries of ED sufferers and their partners,
and a global assessment question about treatment effect on erections.
The data showed that both the men in the Cialis
group and their partners reported a significant increase in the
number of satisfying intercourse attempts compared with the placebo
group. In addition, a significant number of men taking Cialis
reported an increase in the number of successful intercourse attempts
compared with pretreatment. Men treated with Cialis were also
able to achieve penetration and maintain erections significantly
more often than those on placebo. Cialis also significantly increased
the IIEF erectile function domain score compared with placebo.
In this trial, the only three treatment-related
adverse events reported by more than 3 percent of men were headache,
back pain and dyspepsia. These effects were generally mild to
moderate and tended to decrease with time. Only two men discontinued
treatment due to adverse events. No alterations of color vision
were reported. Additionally, no clinically significant changes
were observed in clinical laboratory values, ECGs (electrocardiogram)
or blood pressure at any of the doses studied in this trial. Other
clinical trials are under way to determine the overall safety
profile of Cialis.
According to a recently published study in the
British Journal of Urology, ED is a highly prevalent condition
that affects an estimated 152 million men worldwide.(1) This includes
an estimated 90 million men combined in Brazil, France, Germany,
Italy, Japan, Spain, the United Kingdom and the United States.(2)
The condition is associated with a range of behavioral
risk factors, such as cigarette smoking and excessive alcohol
consumption, as well as numerous other medical conditions, notably
diabetes and cardiovascular disease. As a result of these often
age-related comorbidities, there is a higher prevalence of ED
in older men. Between the ages of 40 and 70 years, for example,
the incidence of severe ED triples from 5 percent to 15 percent,
while moderate ED doubles from 17 percent to 34 percent.
About Lilly ICOS
Lilly ICOS LLC, a joint venture between ICOS Corporation
(Nasdaq:ICOS) and Eli Lilly and Company (NYSE:LLY), is developing
Cialis, which is currently under investigation for the treatment
of both male erectile dysfunction and female sexual dysfunction
(FSD). Eli Lilly and Company, a leading innovation-driven corporation,
is developing a growing portfolio of best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs. ICOS is a product-driven company that has
expertise in both protein-based and small molecule therapeutics.
ICOS, located in Bothell, Wash., combines capabilities in molecular,
cellular and structural biology, high-throughput drug screening,
medicinal chemistry and genomics to develop highly innovative
products with significant commercial potential. The company applies
its integrated approach to specific target areas where it has
expertise. ICOS believes this strategy increases the chances of
successfully developing commercial products. ICOS' disease targets
include erectile dysfunction, female sexual dysfunction, sepsis,
pulmonary hypertension and other cardiovascular diseases.
This press release contains forward-looking statements
about the potential of the investigational compound Cialis(TM)
in treating male erectile dysfunction that reflect management's
current beliefs. However, as with any pharmaceutical under development,
there are risks and uncertainties in the process of development
and regulatory review. There are no guarantees that future clinical
trials will confirm the preliminary results reported in this release
or that the product will receive regulatory approvals or prove
to be commercially successful. For further discussion of these
and other risks and uncertainties, see the U.S. Securities and
Exchange Commission filings of ICOS and Lilly.
(1) Ayta IA, McKinlay JB, Krane RJ. The likely
worldwide increase in erectile dysfunction between 1995 and 2025
and some possible policy consequences. BJU Int 1999; 84: 50-56.
(2) Decision Resources, Inc., Erectile Dysfunction.
Pharmacor Mosaic Service, 2000.
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Marathon Effect'
of Impotence Drug
BBC
News
August, 2002
The drug is being developed in the US, mpotent men who take a
new drug for the condition may be able to have sex up to 24 hours
later, claims the maker Cialis, a medication trying to gain a
foothold in the lucrative anti-impotence market created by Viagra,
is being tested by doctors.
Pharmaceutical firm Eli Lilly wants to be able to market Cialis
in the US from the second half of this year. Their trial involved
223 men with moderate to severe impotence, some of whom were given
Cialis, and the rest a dummy placebo. While the drug group were
statistically more likely to achieve erection, they were also
more likely to have successful second sexual encounters during
a 24-hour period.
Dr Harin Padma-Nathan,
a professor of urology at the University of Southern California,
who led the study, acknowledged that other impotence drugs had
not been tested for this longevity of effect. However, he said:
"We saw a huge clinical difference within 24 hours in patients
taking Cialis and many of the men indicated a sense of freedom
and spontaneity."
Other trials
have also suggested that the drug is effective against some forms
of impotence. It is estimated that more than 7m men worldwide
have taken the original impotence drug, Viagra, since it came
onto the market in 1998. Almost $400m has been spent paying for
the treatment.
It is not
freely available on the NHS, although men with a range of conditions
which cause impotence as a side-effect are given a fixed number
of pills on prescription. Approximately 300,000 NHS prescriptions
for the drug are handed out every year.
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New Phase III
Study Shows, Cialis -- IC351 -- 20 mg Improved Erections in 85
Percent of Men With Erectile Dysfunction Regardless of ED Severity.
Business Wire
June 14, 2001
Clinical trials
with Cialis (IC351), a new PDE5 inhibitor in development by Lilly
ICOS LLC to treat erectile dysfunction (ED), have shown strong
results among men with mild to severe cases of the condition.
Results from several late-stage studies will be highlighted at
this week's 6th Annual Latin American Society for Impotence Research
in Rio de Janeiro.
In one Phase
III study, 85 percent of men taking Cialis 20 mg reported improved
erections, regardless of the severity of their ED(1). In another
study, men reported improved ability to achieve erections with
sexual stimulation even up to 24 hours after taking the drug(2).
The PDE5 inhibitor currently available to treat ED is known to
enable a man to achieve an erection within a four or five hour
period after the drug has taken effect(3).
"Based
on a collective review of the data presented at this meeting --
the strong response rate among men even with severe forms of ED,
the duration and tolerability -- Cialis has the potential to be
a valuable new medical treatment option for men suffering from
ED," said Miguel Rivero, MD, chief of the andrology service,
Hospital Militar Central in Buenos Aires, Argentina. "A new
therapy that also allows a man with ED to have a window of opportunity
for intercourse anytime within a 24-hour period would help him
and his partner regain spontaneity in their sexual relationship."
Cialis significantly
improved erections in men with mild-to-severe ED
The Phase
III study examined the safety and efficacy of "on-demand"
Cialis treatment in 196 men suffering from mild-to-severe ED(1).
Men in the study were randomized to receive up to 20 mg of Cialis
or placebo over a 12-week period. Men were free to take their
study medication without restrictions on food or alcohol consumption
and to have sex with their partners at the time of their choosing
after each dose.
Results showed
that 85 percent of men taking Cialis 20 mg reported significantly
improved erections compared with baseline. In addition, 78 percent
of intercourse attempts recorded by all men on Cialis 20 mg were
successful. Importantly, 63 percent of men with ED treated with
Cialis 20 mg achieved an erectile function score experts consider
"normal" for healthy men as measured by the International
Index of Erectile Function (IIEF).
On the 10
mg dose, 92 percent of men reported improved erections, and 70
percent of intercourse attempts were successful. Forty-two percent
of men taking the 10 mg dose achieved IIEF scores in the normal
range. Fifty-four percent of patients on placebo in the study
reported improved erections, while 43 percent of their attempts
were successful. Twenty percent of men taking placebo attained
IIEF scores in the "normal" range.
In this study,
side effects were mild to moderate, and their incidence diminished
with continued treatment. The most commonly reported side effects
were backache, muscle ache and upset stomach. There were no clinically
significant changes in blood pressure, heart rate, electrocardiograms
or laboratory tests attributable to treatment with Cialis.
Cialis provided
extended duration of responsiveness and worked promptly
Also presented
at this meeting were findings from two Cialis studies designed
to measure responsiveness to the drug(2). In the first study,
61 men with mild-to-severe ED were randomized to receive Cialis
(IC351) 10 mg or placebo. After taking Cialis, the men were evaluated
by RigiScan(TM) (a device for measuring the firmness and duration
of erections) during exposure to visual sexual stimulation. Men
in the Cialis group were significantly more successful in achieving
erections than men in the placebo group at 24 hours postdose.
In the second
trial to measure the onset of responsiveness, 223 men received
Cialis up to 20 mg or placebo in a home-based study. The men were
instructed to take the medication immediately before engaging
in sexual activity and to use a stopwatch to record the elapsed
time until they achieved an erection sufficient for successful
intercourse. In this trial, the ability to achieve an erection
after sexual stimulation was statistically superior in the group
taking Cialis 20 mg compared with the placebo group at 16 minutes
post dosing. Men taking Cialis 20 mg in this study also recorded
statistically greater success at second sexual encounters than
men on placebo for a period of up to 24 hours.
In these studies
on duration of responsiveness, there were no serious side effects.
The most common side effect reported was headache.
Duration of
responsiveness important to men with ED(4)
Duration of
responsiveness following dosing is an important attribute, according
to 88 percent of respondents in a recent Harris Interactive survey
of 256 men with erectile dysfunction in the U.S. The men who participated
in the survey indicated the duration of responsiveness was either
"very important" or "extremely important"
in selecting a treatment.
Erectile dysfunction
is defined as the consistent inability to attain and maintain
an erection sufficient for sexual intercourse. It affects an estimated
152 million men and their partners worldwide with many cases caused
by physical conditions, including cardiovascular disease and diabetes.
About Lilly
ICOS
Lilly ICOS
LLC, a joint venture between ICOS Corporation (Nasdaq:ICOS) and
Eli Lilly and Company (NYSE:LLY), is developing Cialis, which
is currently under investigation for the treatment of sexual dysfunction.
Eli Lilly
and Company, a leading innovation-driven corporation, is developing
a growing portfolio of best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers --
through medicines and information -- for some of the world's most
urgent medical needs.
ICOS Corporation
is a product-driven company that has expertise in both protein-based
and small molecule therapeutics. ICOS, located in Bothell, Wash.,
combines capabilities in molecular, cellular and structural biology,
high throughput drug screening, medicinal chemistry and genomics
to develop highly innovative products with significant commercial
potential. The company applies its integrated approach to specific
target areas where it has expertise. ICOS believes this strategy
increases the chances of successfully developing commercial products.
ICOS' disease targets include sexual dysfunction, sepsis, pulmonary
hypertension and other cardiovascular diseases.
This press
release contains forward-looking statements about the potential
of the investigational compound IC351 in treating male erectile
dysfunction that reflect management's current beliefs. However,
as with any pharmaceutical under development, there are risks
and uncertainties in the process of development and regulatory
review. There are no guarantees that future clinical trials will
confirm the preliminary results reported in this release or that
the product will receive regulatory approvals or prove to be commercially
successful. For further discussion of these and other risks and
uncertainties, see the U.S. Securities and Exchange Commission
filings of ICOS and Lilly.
References
-- 1. ED:
Challenges and solutions. CME symposium sponsored by the Columbia
University College of Physicians and Surgeons. June 1, 2001; Anaheim,
CA..
-- 2. Padma-Nathan,
H. et al. Cialis (IC351) provides prompt response and
extended period of responsiveness for the treatment of men with
erectile
dysfunction. Publishing ID 923: poster presentation at the American
Urology
Association Meeting. June 2001; Anaheim, CA.
-- 3. Sildenafil
label and prescribing information: Summary of Product
Characteristics.
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New Clinical
Data Show Patients Receiving Cialis - tadalafil - Improved Intercourse
Success at 24 and 36 Hours After Dosing.
Business Wire
Issue: May 25, 2002
According
to newly released clinical data on Cialis(TM), an investigational
PDE5 inhibitor being developed by Lilly ICOS LLC for the treatment
of erectile dysfunction (ED), men with ED reported a statistically
significant improvement in successful intercourse attempts at
24 and 36 hours after taking the drug, compared to placebo.
These and
other new findings - including a summary of cardiovascular safety
data that showed no increased incidence of cardiovascular events
during clinical studies - are being presented at the 97th Annual
Meeting of the American Urological Association in Orlando, Florida.
Cialis Period
of Effectiveness - Key Study Findings
In a Phase
III clinical study designed to evaluate the efficacy of Cialis
at specific time points after dosing, 348 men with mild-to-severe
ED were randomly assigned to receive Cialis 20 mg (n=175) or placebo
(n=173) over approximately an eight-week period. Patients were
instructed to attempt intercourse with their partners on four
specific occasions: on two occasions at 24 hours after dosing
and on two occasions at 36 hours after dosing. The primary endpoint
was the percentage of successful sexual intercourse attempts.
"Cialis
was statistically superior to placebo in enabling men with ED
to have successful intercourse at 24 or 36 hours after taking
the drug and showed a consistent effect at both time points,"
said Raymond Rosen, Ph.D., study author and director of the Program
in Human Sexuality at the University of Medicine and Dentistry
of New Jersey and professor of psychiatry, Robert Wood Johnson
Medical School, Piscataway, New Jersey. "Also, in this study,
the duration of effectiveness did not appear to influence the
incidence or severity of side effects."
In addition,
study results show that in secondary measures of efficacy - including
ability to penetrate, satisfaction with hardness of erection and
overall satisfaction - Cialis was statistically superior to placebo
at 24 and 36 hours.
The most commonly
reported (greater than 5 percent) treatment-emergent side effects
in the study were headache, flushing and upset stomach. Less than
two percent of patients taking Cialis or placebo discontinued
the study due to side effects. There were no treatment- emergent
serious adverse events reported.
Cardiovascular
Data - Key Study Findings
The overall
cardiovascular profile of Cialis was summarized based on data
from several Phase III pivotal clinical trials and other studies.
Men with ED with a wide variety of stable cardiovascular conditions,
including patients taking multiple antihypertensive medications,
were included in the Phase III clinical trials. Co-administration
of a nitrate with Cialis is likely to be contraindicated, pending
FDA approval.
"Overall,
the incidence of cardiovascular events was not statistically significantly
different from placebo," said Robert A. Kloner, MD, Ph.D.,
professor of medicine at the University of Southern California
and director of research at the Heart Institute of Good Samaritan
Hospital, Los Angeles. "These newly presented clinical safety
data provide further information for the cardiovascular profile
demonstrated in clinical trials for Cialis."
Findings show
that healthy patients taking Cialis 20 mg had no statistically
significant differences in standing blood pressure and no change
in heart rate, compared to placebo. In addition, the incidence
of heart attack in Cialis-treated patients across all clinical
studies (involving more than 4,000 patients) was not different
from those receiving placebo.
Further, data
collected from large-scale Phase III clinical trials involving
1,328 men with ED show that the overall incidence of cardiovascular
side effects - including flushing, dizziness, hypertension and
syncope (feeling faint/fainting) - in both placebo- and Cialis-treated
patients was not statistically significantly different.
Erectile Dysfunction
- Just the Facts
Erectile dysfunction
is defined as the consistent inability to attain and maintain
an erection sufficient for sexual intercourse. ED affects an estimated
152 million men and their partners worldwide and more than 30
million men in the United States, with many cases caused by physical
conditions, including cardiovascular disease and diabetes.
About Lilly
ICOS
Lilly ICOS
LLC, a joint venture between ICOS Corporation (Nasdaq:ICOS) and
Eli Lilly and Company, is developing Cialis for the treatment
of sexual dysfunction.
Eli Lilly
and Company, a leading innovation-driven corporation, is developing
a growing portfolio of best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs.
ICOS is a
product-driven company that has expertise in both protein-based
and small molecule therapeutics. The Company combines its capabilities
in molecular, cellular and structural biology, high throughput
drug screening, medicinal chemistry and gene expression profiling
to develop highly innovative products with significant commercial
potential. The Company applies its integrated approach to erectile
dysfunction and other urologic disorders, sepsis, pulmonary arterial
hypertension and other cardiovascular diseases, and inflammatory
diseases. ICOS' strategy targets multiple therapeutic areas with
drugs that act through distinct molecular mechanisms, increasing
the Company's opportunities to market breakthrough products.
Certain of
the matters discussed herein with respect to clinical studies
and ICOS and Lilly's products may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements are based on current
expectations, estimates and projections about the industry, management
beliefs and certain assumptions made by management. Investors
are cautioned that matters subject to forward-looking statements
involve risks and uncertainties, including economic, competitive,
governmental, technological 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. More specifically, there can be no assurance that
this product will achieve commercial success or that competing
products will not pre-empt any market opportunity that might exist
for the product.
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In Two New
Studies, Cialis -IC351- Provided an Extended Period of Responsiveness
in Men With Erectile Dysfunction.
Business Wire
May 1, 2001
According
to results of clinical trials released today on Cialis(TM), a
new PDE5 inhibitor in development by Lilly ICOS LLC to treat erectile
dysfunction (ED), men reported an improved ability to achieve
erections even 24 hours after taking the drug. These data will
be presented for the first time at the 96th Annual Meeting of
the American Urological Association in Anaheim, California, in
June.
"Cialis
has the potential to be a valuable new treatment option for men
with ED and their partners," said Dr. Harin Padma-Nathan,
urologist and lead investigator of the study. "A therapy
that allows a man with ED to engage in intercourse within a 24-hour
window permits the couple to regain spontaneity in their sexual
relationship."
Cialis provided
extended duration of responsiveness and worked promptly
In the first
of two trials to measure responsiveness, 61 men with mild-to-severe
ED were randomized to receive Cialis 10 mg or placebo in a clinical
setting. After taking Cialis, men underwent RigiScan(TM) (a device
for measuring the firmness and duration of erections) evaluations
during exposure to visual sexual stimulation. Men in the Cialis
group were significantly more successful in achieving erections
than men in the placebo group, even when evaluated at 24 hours
postdosing.
To measure
the onset of responsiveness in a more natural setting, 223 men
received Cialis (up to 20 mg) or placebo in a second, home-based
study. The men were instructed to take the medication immediately
before engaging in sexual activity and to use a stopwatch to record
the elapsed time until they achieved an erection sufficient for
successful intercourse. In this trial, the ability to achieve
an erection after sexual stimulation was statistically superior
in the group taking Cialis compared with the placebo group at
16 minutes postdosing. Patients on Cialis in this study also recorded
statistically significantly more success at second sexual encounters
than patients on placebo for a period of up to 24 hours after
dosing.
There were
no treatment-related serious adverse events. The most commonly
reported adverse event was headache. "The side effects in
the trials are consistent with other large-scale trials conducted
to date with Cialis," said Dr. Padma-Nathan. "Importantly,
the extended duration of responsiveness does not appear to increase
the rate of side effects or their severity. This is further supported
by the fact that very few men chose to discontinue Cialis treatment
due to side effects."
Extended duration
of responsiveness important to men with ED
Dr. Padma-Nathan
said that these results are especially encouraging in light of
a recent Harris Interactive survey of 256 men with ED in which
88 percent of the men surveyed indicated the duration of responsiveness
was either "very important" or "extremely important"
in selecting a treatment.
Cialis(TM)
Phase II/III Studies Encouraging
In a previously
released Phase II placebo controlled study, Cialis improved erectile
function in up to 88 percent of men with varying degrees of ED.
In a placebo controlled Phase III study in men with difficult-to-treat
diabetes-related ED, up to 64 percent of men reported improved
erections. The trials demonstrated good tolerability over the
entire duration of the medication's effect with headache and dyspepsia
(upset stomach) the most commonly reported side effects. The reported
side effects were transient, generally considered mild to moderate,
and their occurrence diminished with continued treatment. In addition,
there were no serious treatment related adverse events.
Erectile dysfunction
is defined as the consistent inability to attain and maintain
an erection sufficient for sexual intercourse. It affects an estimated
152 million men and their partners worldwide with many cases caused
by physical conditions, including cardiovascular disease and diabetes.
About Lilly
ICOS
Lilly ICOS
LLC, a joint venture between ICOS Corporation (Nasdaq:ICOS) and
Eli Lilly and Company (NYSE:LLY), is developing Cialis, an investigational
PDE5 inhibitor.
Eli Lilly
and Company, a leading innovation-driven corporation, is developing
a growing portfolio of best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs.
ICOS Corporation
is a product-driven company that has expertise in both protein-based
and small molecule therapeutics. ICOS, located in Bothell, Wash.,
combines capabilities in molecular, cellular and structural biology,
high throughput drug screening, medicinal chemistry and genomics
to develop highly innovative products with significant commercial
potential. The company applies its integrated approach to specific
target areas where it has expertise. ICOS believes this strategy
increases the chances of successfully developing commercial products.
ICOS has advanced clinical trials in erectile dysfunction, severe
sepsis and pulmonary arterial hypertension.
This press
release contains forward-looking statements about the potential
of the investigational compound Cialis(TM) (IC351) in treating
male erectile dysfunction that reflect management's current beliefs.
However, as with any pharmaceutical under development, there are
risks and uncertainties in the process of development and regulatory
review. There are no guarantees that future clinical trials will
confirm the preliminary results reported in this release or that
the product will receive regulatory approvals or prove to be commercially
successful. In addition, new pharmaceutical products can face
risks of intellectual property claims and product litigation.
For further discussion of these and other risks and uncertainties,
see the U.S. Securities and Exchange Commission filings of ICOS
and Lilly.
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First Phase
3 Data Show Cialis -IC351- Improved Sexual Function in Men With
Difficult to Treat, Diabetes-related ED.
Business
Wire
April 6, 2001
The first
Phase 3 study for Cialis(TM), a new PDE5 inhibitor being developed
by Lilly ICOS LLC to treat erectile dysfunction (ED), showed strong
results among one of the most difficult to treat populations of
men with ED. The findings--to be released tomorrow at the European
Association of Urology Meeting (EAU)--demonstrated that 64 percent
of men with diabetes-related ED taking Cialis 20 mg on demand
reported improved erections.
"The
impairment of nerve and blood vessel function that accompanies
diabetes makes ED prevalent and particularly difficult to treat
in this population," said Professor Inigo Saenz de Tejada,
of the Foundation for Research and Development in Andrology in
Madrid, Spain. "This study, alongside previously released
data, suggests on demand Cialis may help most men with ED regain
sexual function, regardless of cause or severity." Tejada
noted that while direct comparisons cannot be made to the clinical
trial results of other ED compounds in patients with diabetes,
the 64 percent response rate seen in this Cialis study is impressive.
Sexual function
significantly improved across all study endpoints
In this Phase
3 study, 216 men with mild-to-severe diabetes-related ED were
randomized to receive either placebo or Cialis at doses of up
to 20 mg for 12 weeks. Results indicated 64 percent of men taking
Cialis 20 mg reported improved erections, compared to 25 percent
for placebo. Treatment with Cialis significantly improved sexual
function compared to placebo across all primary and secondary
study endpoints, regardless of patient age, duration and severity
of ED or diabetes.
Importantly,
study participants reflected a broad cross-section of men with
diabetes and included those with poor glucose control, diabetic
retinopathy
(damage to
the retina in the eyes), and diabetic kidney disease. Despite
including men with these diabetes-related complications, few side
effects were reported in this study. Headache and dyspepsia (indigestion)
were the only side effects reported by greater than five percent
of study participants. Researchers observed no significant changes
in clinical laboratory values, ECGs (electrocardiograms) or blood
pressure in this trial. In addition, Cialis use was not associated
with disturbances in color vision for men in the study, including
those with diabetic retinopathy. Of the side effects that were
reported, the majority were mild-to-moderate and appeared to diminish
with continued treatment. Few patients discontinued treatment
due to side effects.
Additional
results from the Cialis global Phase 3 program will be presented
at scientific meetings later this year.
Phase 2: Up
to 88 percent of men with ED of varying etiologies reported improvement
Findings from
a Cialis Phase 2 study are also to be presented at this meeting.
In this study, a broad population of ED sufferers of varying severity
and causes (including men with diabetes) took Cialis on demand
at doses of up to 25 mg for eight weeks. Results indicated that
up to 88 percent of men taking Cialis reported significantly improved
erections, compared with 28 percent of those taking placebo. Headache
and dyspepsia were the only side effects reported by greater than
five percent of all Cialis-treated study participants.
Several measures
of sexual function and satisfaction indicate Cialis superior to
placebo
Men participating
in both studies completed the International Index of Erectile
Function (IIEF), a standard sexual function questionnaire used
by urologists, which includes questions on a man's ability to
achieve and maintain an erection. To evaluate Cialis' effect versus
placebo, researchers compared baseline scores with scores reported
after treatment. Additionally, men and their partners completed
sexual encounter profile (SEP) diaries, indicating their perceptions
on the success and satisfaction of each sexual attempt. Data reported
to date from Phase 2 and Phase 3 studies show treatment with Cialis
significantly increased the number of successful and satisfying
intercourse attempts reported by both men and their partners,
relative to placebo. Cialis was well tolerated and there were
no treatment-related serious adverse events.
ED is a common
complication in men with diabetes
It is estimated
that 150 million adults worldwide have diabetes(1). Experts suggest
that between 25-75 percent of men with diabetes also have ED.
Diabetes can cause vascular complications which, in addition to
ED, can lead to blindness, kidney failure, heart disease and nerve
damage.
According
to a recently published study in the British Journal of Urology,
ED is a highly prevalent condition that affects an estimated 152
million men worldwide(2). This includes an estimated 90 million
men combined in the United States, France, Germany, Italy, Spain,
the United Kingdom, Japan, and Brazil(3). The disorder is associated
with a range of behavioral risk factors, such as cigarette smoking
and excessive alcohol consumption, as well as numerous other medical
conditions, notably diabetes and cardiovascular disease.
As a result
of these often age-related co-morbidities, there is a higher prevalence
of ED in older men. Between the ages of 40 and 70 years, for example,
the incidence of severe ED triples from five percent to 15 percent,
while the probability of moderate ED doubles from 17 to 34 percent.
About Lilly
ICOS
Lilly ICOS
LLC, a joint venture between ICOS Corporation (Nasdaq:ICOS) and
Eli Lilly and Company (NYSE:LLY), is developing Cialis, which
is currently under investigation for the treatment of both male
erectile dysfunction and female sexual dysfunction (FSD).
Eli Lilly
and Company, a leading innovation-driven corporation, is developing
a growing portfolio of best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs.
ICOS Corporation
is a product-driven company that has expertise in both protein-based
and small molecule therapeutics. ICOS, located in Bothell, Wash.,
combines capabilities in molecular, cellular and structural biology,
high throughput drug screening, medicinal chemistry and genomics
to develop highly innovative products with significant commercial
potential. The company applies its integrated approach to specific
target areas where it has expertise. ICOS believes this strategy
increases the chances of successfully developing commercial products.
ICOS' disease targets include erectile dysfunction, female sexual
dysfunction, sepsis, pulmonary hypertension and other cardiovascular
diseases.
This press
release contains forward-looking statements about the potential
of the investigational compound Cialis (IC351) in treating male
erectile dysfunction that reflect management's current beliefs.
However, as with any pharmaceutical under development, there are
risks and uncertainties in the process of development and regulatory
review. There are no guarantees that future clinical trials will
confirm the preliminary results reported in this release or that
the product will receive regulatory approvals or prove to be commercially
successful. For further discussion of these and other risks and
uncertainties, see the U.S. Securities and Exchange Commission
filings of ICOS and Lilly.
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EAU: Cialis
(IC351) Improves Sexual Function In Diabetic Men With Erectile
Dysfunction
Doctor's
Guide
April 6, 2001
The first
Phase 3 study for IC351 (Cialis™), a new PDE5 inhibitor
being developed by Lilly ICOS LLC to treat erectile dysfunction
(ED), showed strong results among one of the most difficult to
treat populations of men with ED. The findings-to be released
tomorrow at the European Association of Urology Meeting (EAU)-demonstrated
that 64 percent of men with diabetes-related ED taking IC351 20
mg on-demand reported improved erections. This rate of response
is considered high given the difficulties associated with treating
diabetes-related ED.
"The
impairment of the nerves and blood vessels that accompanies diabetes
makes ED prevalent and particularly difficult to treat in this
population," said Dr. Gerald Brock, a urologist from St.
Joseph's Health Centre in London, Ontario. "This study, alongside
previously released data, suggests that on-demand Cialis may help
most men with ED regain sexual function, regardless of cause or
severity."
In this Phase
3 study, 216 men with mild-to-severe diabetes-related ED were
randomized to receive either placebo or IC351 at doses of up to
20 mg for 12 weeks. Results indicated 64 percent of men taking
IC351 20 mg reported improved erections, compared to 25 percent
for placebo. Treatment with IC351 significantly improved sexual
function compared to placebo across all primary and secondary
study endpoints, regardless of patient age, duration and severity
of ED or diabetes.
Importantly,
study participants reflected a broad cross-section of men with
diabetes and included those with poor glucose control, diabetic
retinopathy (damage to the retina in the eyes), and diabetic kidney
disease.
Despite including
men with these diabetes-related complications, few side effects
were reported in this study. Headache and dyspepsia (stomach upset
following meals) were the only side effects reported by greater
than five percent of study participants. Researchers observed
no significant changes in clinical laboratory values, ECGs (electrocardiograms)
or blood pressure in this trial. In addition, IC351 use was not
associated with disturbances in color vision for men in the study,
including those with diabetic retinopathy. Of the side effects
that were reported, the majority were mild-to-moderate and appeared
to diminish with continued treatment. Few patients discontinued
treatment due to side effects.
Additional
results from the IC351 global Phase 3 program will be presented
at scientific meetings later this year.
Findings from
a IC351 Phase 2 study are also to be presented at the European
Association of Urology Meeting (EAU). In this study, a broad population
of ED sufferers of varying severity and causes (including men
with diabetes) took IC351 on-demand at doses of up to 25 mg for
eight weeks. Results indicated that up to 88 percent of men taking
IC351 reported significantly improved erections, compared with
28 percent of those taking placebo. Headache and dyspepsia were
the only side effects reported by greater than five percent of
all IC351-treated study participants.
Men participating
in both studies completed the International Index of Erectile
Function (IIEF), a standard sexual function questionnaire used
by urologists, which includes questions on a man's ability to
achieve and maintain an erection. To evaluate IC351's effect versus
placebo, researchers compared baseline scores with scores reported
after treatment. Additionally, men and their partners completed
sexual encounter profile (SEP) diaries, indicating their perceptions
on the success and satisfaction of each sexual attempt. Data reported
to date from Phase 2 and Phase 3 studies show treatment with IC351
significantly increased the number of successful and satisfying
intercourse attempts reported by both men and their partners,
relative to placebo. IC351 was well tolerated and there were no
treatment-related serious adverse events.
It is estimated
that 150 million adults worldwide have diabetes. Experts suggest
that between 25-75 percent of men with diabetes also have ED.
Diabetes can cause vascular complications which, in addition to
ED, can lead to blindness, kidney failure, heart disease and nerve
damage.
According
to a recently published study in the British Journal of Urology,
ED is a highly prevalent condition that affects an estimated 152
million men worldwide. The disorder is associated with a range
of behavioral risk factors, such as cigarette smoking and excessive
alcohol consumption, as well as numerous other medical conditions,
notably diabetes and cardiovascular disease.
As a result
of these often age-related co-morbidities, there is a higher prevalence
of ED in older men. Between the ages of 40 and 70 years, for example,
the incidence of severe ED triples from five percent to 15 percent,
while the probability of moderate ED doubles from 17 to 34 percent.
SOURCE; Eli
Lilly Canada Inc.
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Lilly,
Bayer Ready Drugs to Take on Pfizer's Viagra
WALL STREET JOURNAL
July 24, 2001
When people
think impotence, they think Viagra. Soon, that may change.
Two "sons
of Viagra" are close to reaching the market, and doctors
say these new drugs may have some definitive advantages. They
work in a similar way, but they seem to act faster and cause fewer
of the trademark Viagra side effects: headaches, nasal congestion,
flushed faces and blue vision.
To tout the
new drugs' advantages, their makers can unleash some serious marketing
firepower -- sufficient to give Pfizer Inc., which effectively
created the pharmaceutical market for alleviating erectile dysfunction
when it launched Viagra a few years ago -- a run for its money.
A lot of money is at stake. Viagra's sales totaled $1.3 billion
last year and are projected to rise to $1.6 billion this year.
The two new
rivals are Cialis, made by Eli Lilly & Co. and its biotechnology
partner, Icos Corp.; and vardenafil, made by Bayer AG. Lilly and
Icos applied to the U.S. Food & Drug Administration last month
to begin marketing Cialis. Vardenafil is in final clinical trials,
and Bayer says it will seek FDA approval this fall. Both drugs
could reach the market next year.
Cialis and
vardenafil act in the same way as Viagra, by blocking an enzyme
called phosphodiesterase-5, or PDE-5, and in the process relaxing
smooth muscle cells in the penis and elsewhere. In causing these
muscles to relax, the drugs effectively increase blood flow to
the penis.
Though they
work in similar ways, Cialis, vardenafil and Viagra are distinctly
different chemical entities. Some urologists say vardenafil and
Cialis are more effective at blocking the PDE-5 enzyme and hence
potentially more potent than Viagra. This means they could act
as well as, or better than, Viagra at smaller doses. They also
interact with fewer other molecules and hence might have fewer
side effects.
In the looming
marketing battle, Viagra starts out with some advantages, Pfizer
argues. The company has conducted more than 80 studies of Viagra,
says Michael Widlitz, a vice president at Pfizer, and "no
competitor can hope to ascend this mountain of efficacy and safety
data."
Drug-industry
executives estimate that 30 million American men suffer from some
degree of erectile dysfunction; about one-third have tried Viagra.
Pfizer says 66% of men with erectile dysfunction who have taken
Viagra in clinical trials report being able to have sexual intercourse,
as compared with 20% who were not given the drug. And a survey
of 500 urologists by Boston's SG Cowen Securities Corp., which
has handled stock offerings for Icos, found that more than 95%
said their patients were satisfied with Viagra.
On the other
hand, about 50% of men who take Viagra don't renew their prescriptions.
Pfizer says Viagra doesn't work on about 25% of them and some
others may have had too high expectations. And if the competing
drugs prove to be more effective and cause fewer side effects,
as clinical trials suggest, they may lure Viagra users as well,
according to Maury Jayson, a urologist in New York. "They
look like they could be more potent, super Viagras," he says.
No one can
make a definitive comparison between the drugs because there have
been no public head-to-head clinical trials. But the newcomers
are already zeroing in on what they believe are their drugs' advantages
over Viagra. Cialis, for instance, gave men improved ability to
have sex for up to 24 hours, according to results from a study
presented at a medical conference recently. In contrast, Pfizer
recommends that men have sex within four hours of taking Viagra.
"Patients
should not have to worry about watching the clock and planning
their sex life around the time they take a drug," says Paul
Clark, chief executive officer of Icos. "Cialis allows you
to have a more spontaneous relationship."
In addition,
Cialis and vardenafil may take effect faster than Viagra, urologists
say. Pfizer advises patients to take Viagra an hour before attempting
sexual intercourse. In a clinical trial, a majority of patients
who took Cialis were able to engage in sexual intercourse within
30 minutes of taking the drug. Bayer hasn't conducted a similar
trial to test how quickly vardenafil acts, but Irwin Goldstein,
a professor of urology at Boston University School of Medicine
who has conducted clinical investigations of vardenafil, says
his patients seem to experience a faster onset than Viagra.
Cialis's longer
duration could pose safety problems, according to Dr. Goldstein.
"What happens if you take Cialis three times a week?"
he asks. "If you block enzyme regulation for a prolonged
period of time, it's not known what the effects are." (Icos
says the safety concerns are unfounded and patients have taken
the drug every day for six months in a clinical trial and fared
fine.)
Some urologists
say patients who have used Cialis and vardenafil seem to experience
fewer side effects. Dr. Goldstein says, "There's no question
patients find vardenafil better than Viagra."A Pfizer spokesman
says the company won't respond to assertions about the other drugs
because it hasn't seen details of the studies. He says the company
prefers to stand by Viagra's record so far as a safe and effective
drug.
So far, Pfizer
says, doctors around the world have written 40 million prescriptions
for Viagra, and 13 million men have tried it. A study in the British
Journal of Urology estimated that about 150 million men in the
world suffer from erectile dysfunction. Prostate surgery, diabetes
and heart disease often contribute to the problem.
John Borzilleri,
senior vice president in money management at State Street Research
& Management in Boston, predicts the total market will double
in the next few years to about $3 billion in sales. Perhaps the
best situation that could result for Viagra is that the new drugs
could expand the market for impotence drugs so much that Viagra
won't lose sales to the newcomers.
With so many
potential patients, the new drugs will indeed increase the number
of users, says William Tanner, a biotech analyst at SG Cowen.
"The
pie will grow," says Dr. Jayson, the New York urologist.
"The only question is how it will be divided."
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A Longer Lasting
Viagra? Eli Lilly/Icos Developing a Longer Lasting Competitor
to Pfizer's Viagra
ABCnews.com
June, 2002
Cialis, a
drug being developed by Eli Lilly and Co. and Icos Corp., may
be able to give men erections for 24 hours after they take the
drug, or approximately 20 hours longer than Viagra can. "Cialis
has the potential to be a valuable new treatment option for men
with ED [erectile dysfunction] and their partners," says
Dr. Harin Padma-Nathan, a urologist with the University of Southern
California and lead investigator of two studies testing the drug
for the companies.
"A therapy that allows a man with ED to engage in intercourse
within a 24-hour window permits the couple to regain spontaneity
in their sexual relationship." Viagra's manufacturer, Pfizer,
Inc., recommends men take Viagra about one hour before engaging
in sexual activity. The drug helps men get an erection if they
are sexually excited in about 30 minutes, and it lasts up to four
hours, the company says.
Erections Up to 24 Hours Later
In one of
the studies being reported today, 61 men with mild to severe erectile
dysfunction received either Cialis or a placebo in a clinical
setting. The doctors were not aware which patients received the
drug or the placebo until after the data was collected.
After taking the drug and looking at sexual images, the doctors
measured the men's response with a RigiScan, or a device that
measures the firmness and duration of erections.
The men taking the Cialis were more successful at achieving erections,
even up to 24 hours later, Padma-Nathan reports.
Sixteen Minutes to Action?
In another
study, 223 men took the drug or a placebo at home, in a more natural
setting. The men were instructed to take the drug before engaging
in sexual activity and to use a stopwatch to record the time it
took to achieve an erection. Men were able to get an erection
as early as 16 minutes after taking the drug and could have a
second sexual encounter up to 24 hours later, Padma-Nathan found.
The firms report no significant side effects from the drug, except
headaches.
Too Soon to Tell For Public Use
Experts commenting
on the studies said it was too early to tell if Cialis represented
an improvement on Viagra. "It would have to be tested head
to head with Viagra rather than a placebo to see if it is better,"
says Dr. Michael P. O'Leary, associate professor of urology at
Harvard Medical School. More men also need to be tested to see
if any side effects show up in a larger population. The firms
are continuing with larger studies of the drug and plan on doing
comparison tests with Viagra, says Lacy Fitzpatrick, a spokeswoman
for Icos.
The findings of these studies will be presented at the 96th annual
meeting of the American Urological Association next month in Anaheim,
Calif.
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Pfizer fears
rivals' potency Viagra, the impotence treatment, has made millions,
but two new drugs could spoil the fun
The
Guardian
October 24, 2002
When a London
critic lauded the stage performance of actress Nicole Kidman as
"theatrical Viagra", his meaning was perfectly clear.
The drug to treat impotence has annual sales of $1.5bn and has
rapidly become a household name in the five years since it first
appeared on the market. So much so that it can now stand in as
a metaphor. But Pfizer, the pharmaceutical firm behind the best-selling
product, may no longer have things entirely its own way.
Pending final
approval by regulators, Viagra is about to face some competition
from rival drugs promising quicker and longer lasting results
- a joint venture between Bayer and GlaxoSmithKline dubbed Levitra
and another rival treatment by Eli Lilly and Icos Corporation
called Cialis.
Both are planning
to launch early next year, setting the scene for one of the most
expensive and fiercely contested marketing battles the drugs industry
has ever seen. Pfizer yesterday filed a suit in an attempt to
block the launch of the drugs in the US but similar legal action
in Europe has already failed.
Experts estimate
that around 30m men suffer from some form of erectile dysfunction
in the US and only 10% receive any kind of treatment, which means
there is still a huge untapped market. Worldwide the number of
sufferers reaches 152m. Demographics are also making the erectile
dysfunction market more attractive for the drug industry as baby
boomers move towards retirement age.
For the companies
involved there is a lot at stake. The industry is being battered
by the onslaught of cheap generic rivals as patents on a string
of bestsellers expire. Regulators are getting tougher on safety
and trial data on new drugs and political pressure is pushing
prices lower. This comes as the pipeline of possible new blockbusters
is dwindling. The volume of new drugs on the market in 2001 was
the lowest for eight years.
Salomon Smith
Barney has suggested that both of the new impotence drugs have
potential sales of $1bn a year. Lehman Brothers estimates that
sales of erectile dysfunction drugs will reach $6bn globally within
six to seven years.
"Erectile
dysfunction is a very serious condition," said Alan Riley,
professor of sexual medicine at the University of Central Lancashire
and president of the British Society for Sexual and Impotence
Research. "Men who suffer from it are often pretty miserable.
It can cause breakdown in marriages and men to lose their jobs
because they become preoccupied with failure. It does have profound
effects - there are even instances of suicide. But we are still
only seeing the tip of the iceberg seeking treatment."
All three
impotence drugs work in a similar fashion. They block an enzyme
called phosphodiesterase 5, otherwise known as PDE-5, which relaxes
certain muscle cells and allows increased blood flow into the
penis. They act as an enabler, allowing users to achieve an erection
when sexually stimulated.
Pfizer tried
to prevent other companies using the mechanism in Europe but was
unable to patent it because it was already ruled to be in the
public domain. Pfizer received a broad patent in the US this week
covering the use of PDE-5 and forming the basis of its suit but
analysts are doubtful it will succeed. A spokeswoman for Icos
said the company would "vigorously defend" its position
and said the claim to use a patent on PDE-5 inhibitors had already
been invalidated by the European patent office and in UK appeal
courts.
Longer lasting
Eli Lilly
and Icos say that Cialis will produce longer lasting effects than
the Pfizer treatment. Viagra takes about an hour to work and then
lasts for between three and four hours - although some men still
benefit 12 hours later. Its absorption is also inhibited if taken
after food. With Cialis, the tests showed that 59% of men still
reported the ability to have sex 36 hours after taking it. In
addition, food does not affect Cialis, or Levitra, according to
the available data.
Dr Anthony
Beardsmith, who has worked on the development of Cialis at Eli
Lilly, said the drug uses "exactly the same mechanism as
Viagra so the efficacy data is pretty much the same. Around four
out of five people are able to achieve an erection and three out
of four are able to achieve sexual intercourse. The main difference
is the 'half life' - a measure of how long it will stay active.
With Cialis the half life is 17 hours and with Viagra it is three
to four hours. Cialis is active in the body for much longer."
Mark Barbato
is executive director at Eli Lilly in Indianapolis and product
team leader for Cialis. "With current therapies people are
tied to a stopwatch," he said. "You have to wait a while
after food before you can take it and then you have a window of
a few hours. Cialis puts more spontaneity back into it. In France
it is already being called the 'le weekend' drug. The basic clinical
effects are very similar to Viagra and the side effects are very
similar (around 14% experience headaches and 9% heartburn) so
it will come down to how it applies to the day-to-day usage."
The companies
behind the rival drugs are each banking on success. Bayer found
fame when it developed aspirin more than a century ago but has
been in the headlines recently after it was forced to withdraw
Baycol, its cholesterol-lowering drug, when it was linked to dozens
of deaths.
Eli Lilly,
which has suffered falling profits, is desperate for new drugs
to replace the loss of patent protection on Prozac, its popular
anti-depressant. It has also been hit by US regulators raising
quality-control questions over some of its factories.
For GlaxoSmithKline,
it is a case of convincing investors that the merger of Glaxo
Wellcome and SmithKline Beecham two years ago has done more than
just deliver some short-term cost-cutting gains. Loss of patents
on some drugs has pushed Glaxo's share price to five-year lows.
But taking
on Pfizer, the biggest drug company in the world, will not be
easy. It spent about $100m on marketing Viagra last year and has
armies of sales people. The company is the process of a $53bn
takeover of rival Pharmacia to cement its place at the top.
Brand recognition
Geoff Cook,
a Pfizer spokesman, said the brand recognition of Viagra also
gave the company a tremendous advantage. "It's rare to have
a brand like Viagra - our rivals will never have that recognition
because we have the advantage of being identified with a scientific
breakthrough. This is also a proven entity with a history of safety
and efficacy, which has been dispensed by 600,000 physicians and
used by 20m men."
He also shrugged
off the threat posed by the claims of longer lasting effects.
"There is no real evidence that they are benefits. The fact
is that in the real world our target audience is having one or
two sexual encounters a week and it isn't necessary for the effects
to last longer," he said. "And if the drug lasts longer
then so, potentially, do any side effects."
Assuming the
launches go ahead, the US marketing campaigns for Levitra and
Cialis are likely to emphasise lifestyle and aspirational images.
The Levitra name is derived from the French masculine pronoun
'le' and 'vita', which is Latin for life, and uses a flame for
a logo. Cialis is a wordplay on 'ciel', the French for sky.
In Britain,
where there are an estimated 2.5m sufferers, the marketing campaigns
will be behind the scenes. Unlike the US, where direct-to-consumer
advertising is allowed for prescription drugs, Europe has a total
ban on any kind of promotion.
But in an
increasingly global media marketplace, heavy promotion in the
US naturally bleeds into Europe. The companies are counting on
it.
"We actually
think the competition is a good thing," Mr Cook said. "The
reality is that the biggest competition for us is getting men
off their couch and into the doctor's offices. Embarrassment prevents
a lot of men from going to the doctor and seeking help. If this
creates more interest in the area and generates more coverage
then it makes things easier for everyone."
Thrills and
pills
· Viagra
appeared five years ago and now has annual sales of $1bn. Estimates
suggest sales of erectile dysfunction drugs will reach $4bn globally
within six to seven years.
· 30
million men suffer from some form of erectile dysfunction in the
US and only 10% receive treatment. Worldwide the number of sufferers
reaches 152million.
· Viagra-style
drugs work by blocking an enzyme called phosphodiesterase 5, otherwise
known as PDE-5, which relaxes certain muscle cells and allows
increased blood flow into the penis.
· Viagra
takes about an hour to work and lasts for between three and four
hours - though some men benefit up to 12 hours later.
· Pfizer
claims Viagra has been dispensed by 600,000 doctors and used by
20 million men.
· The
brand name chosen for Icos and Eli Lilly's drug is reported to
have drawn opposition from several members of a family with the
last name Cialis.
· It
took more than a year to whittle about 700 possible names down
to Levitra, derived from "le", the French masculine
pronoun, and "vita", Latin for life.
· Israeli
scientist, Ya'acov Leshem, at Bar-Ilan University, put Viagra
into a vase of cut flowers and found they stayed fresh for a week
longer than usual by increasing nitric oxide in them.
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FDA Accepts
Cialis NDA.
Business
Wire
Issue: August 31, 2001
ICOS Corporation
(Nasdaq:ICOS) announced today that the New Drug Application (NDA)
for Cialis(TM) has been accepted for review by the U.S. Food and
Drug Administration. "Even though it was stated in our last
quarterly conference call, that we probably would not make an
announcement, several of our shareholders have made inquiries
and therefore, we decided to make this release," stated Lacy
Fitzpatrick, Associate Director of Investor Relations.
ICOS is a
product-driven company that has expertise in both protein-based
and small molecule therapeutics. The Company combines capabilities
in molecular, cellular and structural biology, high throughput
drug screening, medicinal chemistry and genomics to develop highly
innovative products with significant commercial potential. The
Company applies its integrated approach to specific target areas
where it has expertise. ICOS believes this strategy increases
the chances of successfully developing commercial products. These
target areas include erectile dysfunction, sepsis, psoriasis,
pulmonary hypertension and other cardiovascular diseases.
This press
release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties that
could cause the Company's results and the timing of certain events
to differ materially from those discussed in the forward-looking
statements, including risks associated with clinical development,
regulatory approvals, product commercialization, intellectual
property claims and litigation and other risks detailed in the
Company's latest Annual Report on Form 10-K and its other public
filings filed with the Securities and Exchange Commission.
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