Cialis Development Story
Cialis
Impotence sufferers are ready for more exciting news! A new medical
breakthrough is claimed to deliver more benefits than Viagra!
You
be the judge.
Why Cialis?
Pfizer
formulated a medication they named 'Sildenafil Citrate'. It was
originally invented as a medication for high blood pressure and
angina but it was a real flop. Then when Pfizer tried to stop the
testing, men refused to give their samples back. The researchers
immediately realised men in the sample group were up to something
outside of the normal test program. It was not long before Pfizer
realised they were onto something! So, they put it into a tablet,
called it 'Viagra®', and made $ millions.
Not to be caught flat footed, some clever resesearchers at Eli
Lilly & co, (makers of Prozac amongst other things) and
ICOS, formed
a joint venture called Lilly
ICOS. They assayed samples of Sildenafil Citrate and experimented
with ways to make it more effective. They hit the jackpot and called
the chemical compound 'Tadalafil', and gave it the trade name 'Cialis®'.
What's so good about it?
Like Viagra®, it's very easy to use. However, it is a more
effective and powerful product. It starts working up to twice as
fast as Viagra and continues to work for between 24 to 36 hours,
compared to Viagra's 6-8 hour effective life.
It also works for more people; In clinical tests Viagra®, was
found to work for 75% of people that tried it. Under the same test
conditions Cialis® was found to work for 88% of men that tried
it. Researchers claim it works twice as fast as Viagra with fewer
side effects. In clinical studies Cialis helped 88 percent of men
achieve erections in 30 minutes or less. The study also showed that
Cilias continued to stay in the system for up to 24 hours!
Cialis works exactly like Viagra only one difference. Cialis has
the ability to target the PDE5 receptors better. PDE5 enzymes control
different actions of cells in the body including the brain, heart
and eyes. If these receptors are not targeted effectively, certain
side effects can occur such as blurred vision, headaches, nausea,
and/or heart complications.
Marketing analysis are already predicting that Eli Lilly &
CO, the makers of Cialis, will hit at least US $600 million in sales
within the first year. That has already put Pfizer into scrambling
mode trying to develop campaigns to survive the shift in sales.
FAQ
What is Cialis?
Cialis is in a class of medications known as PDE-5 inhibitors, which
are used to treat cases of male impotence. The expected date Cialis
will become available worldwide is still unknown, however many marketing
analysts are predicting by the begining of next fall.
How does Cialis work?
Cialis acts in the same way as Viagra, by blocking an enzyme called
phosphodiesterase-5, or PDE-5. This helps the smooth muscles in
the penis relax and widen, which allows for more blood to enter.
As a result, you gain erections faster and easier.
What's the difference between Viagra® and Cialis®?
Cialis® comes in smaller doses and produces fewer side effects.
Cialis® also works much faster than Viagra®. In clinical
trials, the majority of men who took the drug were able to engage
in sexual intercourse within 30 minutes or less. The studies also
indicated that Cialis® stays in the system for up to 24 hours.
That's 18 hours longer than the traditional Viagra® treatment.
Test results have also shown that Cialis® has no adverse side
effects on vision or the heart. It's believed that Cialis® is
more selective than Viagra® at targeting PDE5 receptor sites.
Besides controlling blood flow to the penis, PDE5 enzymes play in
essential role in the action of cells in the brain, heart, kidney,
and eyes.
How well does Cialis® work?
Test results showed that out of 700 participants at least 88% of
men experienced improvement with their erections.
What's the normal dose?
In clinical testing most men were administered one 10 or 20 mg tablets
per day.
Are there any side effects?
The most common side effects reported in the study were headache,
myalgia (muscle pain), dyspepsia (upset stomach following meals)
and back pain. The severities of these side effects were minimized
with lower doses.
May 28, 2002 News report.
Lilly Icos reports positive phase 3 results for Cialis®
Lilly Icos LLC, a joint venture between Icos Corp. of Bothell and
Eli Lilly and Co., said Tuesday that its experimental Cialis erectile
dysfunction treatment performed well in a phase 3 clinical trial.
Patients who took the drug reported results "statistically
superior" to those who were given a placebo. The eight-week
trial was designed to evaluate the efficacy of Cialis® at 24
hours and 36 hours after taking the drug, and in both cases patients
reported "significant improvement" compared to the placebo
group. More exact study data were not released.
In earlier trials the company had found Cialis® lasted up
to 24 hours, compared to about four hours for Viagra, Pfizer's blockbuster,
with which Cialis would compete if approved. Those early studies
have shown the drug to be successful in treating about 88 percent
of erectile dysfunction patients, with fewer side effects than Viagra®.
Lilly Icos also said safety data from the trial gave no indication
of increased incidence of cardiovascular problems. Less than 2 percent
of the 348 patients taking Cialis® or placebo discontinued the
study due to side effects, which included headache, flushing and
upset stomach.
The company did not update the timeline to its commercial launch
of Cialis®. On April 30, the company delayed the release until
sometime in 2003 after the Food and Drug Administration asked for
more information about the drug. It had hoped to launch this year.
The company filed its application for the approval of Cialis®
in June 2001 and received word from the FDA on Aug. 31 that it was
accepted for review. In a press release April 30, the company said
the FDA required additional clinical studies, labeling discussions
and manufacturing inspections before it would give its final approval.
8/30/01
Business Editors, Health/Medical Writers
BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 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.
7/24/01
Published on JULY 24, 2001 in the WALL STREET JOURNAL
Lilly, Bayer Ready Drugs to Take On Pfizer's Viagra
by GEETA ANAND AND THOMAS M. BURTON
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 ompany 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 uestion is how it will be divided."
07/12/01
Lilly Icos applies for European approval of Cialis
Lilly Icos LLC, a joint venture between Icos Corp. of Bothell and
Eli Lilly and Co. of Indianapolis, Ind., said Thursday it has filed
an application for approval of Cialis, its erectile dysfunction
treatment, for use in Europe. The filing, made to the European Agency
for the Evaluation of Medicinal Products, follows closely the June
28 new drug application for Cialis to the U.S. Food and Drug Administration
for use in the United States.
Lilly Icos hopes that Cialis can be brought to market to compete
with Viagra, Pfizer Inc.'s enormously successful ED drug.
The company said ED affects about 31 million men in Europe, and
about 152 million men worldwide.
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