Erectile dysfunction drug Cialis (tadalafil) does well in US market

After only six months, Cialis (tadalafil)1, the latest oral erectile dysfunction (ED) treatment on the market in the U.S., is challenging Viagra (sildenafil citrate)2for share of the ED market as Cialis leads in new treatment initiations by urologists3 and switches from other products for April. Cialis is marketed by Lilly ICOS LLC, a joint venture between Eli Lilly and Company (NYSE: LLY) and ICOS Corporation (Nasdaq: ICOS). Cialis is the only ED treatment shown to improve erectile function up to 36 hours in most men. Cialis can be taken without regard to food.

Cialis Leads in New Treatment Initiations

According to market research firm ImpactRx (which tracks the habits of a panel of high prescribing physicians and may reflect emerging trends in doctors' offices today)4, U.S. urologists initiated treatment with Cialis in April at a rate of more than two-to-one over each of the other oral ED treatments. In fact, Cialis represented 56 percent of new treatment initiations by urologists in April, compared to 21 percent for Levitra (vardenafil HCl)5 and 23 percent for Viagra.6

Based on data from IMS, another source of market information, in April, Cialis represented 30 percent of new ED treatment prescriptions written by urologists, compared to 16 percent for Levitra and 54 percent for Viagra.7

Cialis Leads in Switches

In April, nearly two thirds of all men who switched their oral ED treatment switched to Cialis. Following is information from ImpactRx on share of new prescriptions written in April by doctors changing their patients' ED treatment from product to another.

CIALIS
Primary Care Physicians 60% Urologists 69%

LEVITRA
Primary Care Physicians 36% Urologists 26%

VIAGRA
Primary Care Physicians 4% Urologists 5%

In an independent clinical study, more men selected Cialis as their preferred treatment of choice after trying different oral ED medications, primarily because of how long the drug worked.8 This may explain why many men with ED who are on oral treatment are switching to Cialis.

Cialis Challenges Viagra

The percentages of new prescriptions written by all doctors for oral ED treatments in April broke out as follows: Cialis, 19 percent; Levitra, 14 percent; and Viagra, 67 percent.9 "The early success of Cialis in the U.S. is similar to the trend we saw when it first became available in other countries. Cialis has claimed market shares of 19 percent to 39 percent across Europe, and even higher in some other markets," said Leonard Blum, vice president of marketing, ICOS Corporation. In the first quarter of 2004, Cialis achieved $108 million in global sales. More than two million men around the world have been treated with Cialis since its first introduction globally last year.

"For us, the number of Cialis prescriptions written by urologists is one of the most important indicators of future trends. Urologists are the experts in treating ED. We expected that urologists would be the quickest adopters of Cialis, and the data suggest that these specialists, like their peers overseas, are making Cialis their preferred treatment," said Blum.

Benefits of Cialis

Cialis is changing the way doctors and patients think about treating ED by offering two important benefits: a 36-hour window of opportunity for intimacy and the ability to take the tablet on an empty stomach or with a meal, without concern that high-fat food will reduce the absorption of the medicine.

"What the marketplace tells us is that men and their partners are truly taking advantage of the benefits of Cialis," said Matt Beebe, U.S. brand team leader for Cialis, Lilly ICOS LLC. "Men can take Cialis Friday evening and choose the moment for romance as late as Sunday morning. Because Cialis works for up to 36 hours, it allows a man and his partner to relax, forget about planning intimacy and let it happen when the moment is right for them."

About Cialis

Cialis, approved by the FDA in November 2003 for the treatment of erectile dysfunction, is the only oral ED treatment shown to improve erectile function up to 36 hours in most men. Cialis can be taken without regard to food. The absorption of Cialis is not reduced by food, including high-fat foods. Cialis is currently available in more than 60 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than two million patients worldwide have been treated with Cialis since its first introduction in February 2003.

Cialis is available by prescription only and is not for everyone. Men taking nitrates, often used for chest pain, or certain alpha-blockers for prostate problems or high blood pressure, should not take Cialis. Such combinations could cause a sudden, unsafe drop in blood pressure.

Men should discuss their health status with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity.

The most common side effects with Cialis were headache, upset stomach, delayed backache and muscle ache. Although rare, men who experience an erection for more than four hours should seek immediate medical attention. Men should not drink alcohol in excess with Cialis. Cialis studies were not designed to assess multiple intercourse attempts after a single dose.

For full patient information, visit www.cialis.com.

About ED

ED 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.10 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.11,12 In many cases, however, both psychological and physiological factors contribute to the condition.13

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, developed tadalafil for the treatment of erectile dysfunction.

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. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

ICOS Corporation, a biotechnology company, is dedicated to bringing innovative therapeutics to patients. Headquartered in Bothell, Wash., ICOS is marketing its first product, Cialis (tadalafil), for the treatment of erectile dysfunction. ICOS is working to develop treatments for serious unmet medical conditions such as chronic obstructive pulmonary disease, cancer and inflammatory diseases.

B-roll is available via satellite, C-band feed:
WEDNESDAY, JUNE 2, 10:30 - 11:00 AM EDT C-Band, IA 6, Tr. 21, DL 4120
WEDNESDAY, JUNE 2, 13:15 - 13:45 PM EDT C-Band, IA 5, Tr. 23, DL 4160
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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. 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. 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. 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. 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.

Erectile Dysfunction -- The Canary In The Mineshaft?

New research into urologic conditions - such as erectile dysfunction - indicate that these disorders could be associated with or precursors to more serious conditions, and suggest a need for practitioners to view these diseases in the greater context of total health as opposed to isolated disorders. A special session highlighting the association on urologic diseases with non-urologic conditions such as heart disease and metabolic syndrome was presented during the 102nd Annual Scientific Meeting of the American Urological Association. A special session for the media was moderated by Marshall L. Stoller, M.D.

ENDOTHELIAL DYSFUNCTION AND OXIDATIVE STRESS ASSOCIATED WITH THE METABOLIC SYNDROME CAN BE REVERSED BY A CHRONIC TREATMENT WITH SILDENAFIL (Abstract 686)

Metabolic syndrome is characterized by a number of conditions, including elevated blood pressure, excess body fat around the waist and insulin resistance. Many patients with these conditions also exhibit endothelial dysfunction with increases in oxidative stress and decreases in nitric oxide production - which has been related to erectile dysfunction (ED). Researchers from France explored whether treatment with sildenafil - a common pharmacologic treatment for ED - could improve endothelial dysfunction in a rat model.

Researchers administered sildenafil to fructose-fed rats to achieve plasma concentrations known to give efficacy in men and observed endothelial function and oxidative stress in the animals during treatment and one-week after treatment had been stopped. It was observed that chronic sildenafil treatment improved endothelial function and oxidative stress, suggesting that this treatment could be a benefit for cardiovascular indications as well as erectile dysfunction.

ERECTILE DYSFUNCTION AND CORONARY HEART DISEASE (Abstract 864)

Research has shown a connection between erectile dysfunction (ED) and cardiovascular disease (CVD) in men, and has established a need to consider one a precursor to the other. Researchers further evaluated the association of these two conditions and whether the association could be age-related.

A random sample of men from the Olmsted County population was evaluated by questionnaire, and community medical records of the subjects were examined. Logistical regression models examined the associations between ED and CVD. Men with CVD were 4.2 times more likely to have ED than men without heart disease. The results underscore a need to consider sexual function in men with heart disease and CVD in men with ED.

ERECTILE DYSFUNCTION, METABOLIC SYNDROME, HYPOGONADISM ARE INTERTWINED (Abstract 863)

If left untreated, metabolic syndrome can lead to an increased risk for diabetes mellitus and cardiovascular disease - both known risk factors for erectile dysfunction (ED). Hypogonadism, or low testosterone, is an etiological factor for metablic syndrome and an etiological factor in ED. Using a sample of men with ED, German researchers investigated symptoms and incidence of metabolic syndrome and hypogonadism.

771 erectile dysfunction patients were given comprehensive screening for symptoms of hypogonadism and metabolic syndrome over a two-year period. 18.3 percent had testosterone levels less than 12 nmol/L. Of this hypogonadal subgroup, average abdominal girth was 112.2 cm, 35 percent had arterial hypertension, 21 percent were dyslipemic and 14 percent had benign prostatic hyperplasia or lower urinary tract symptoms. In this group, eight men had not yet been diagnosed with diabetes mellitus, 12 had not been diagnosed with dyslipemia and five had not yet been diagnosed with heart disease. These results indicate a link between erectile dysfunction and other major health conditions, and suggest that erectile dysfunction be considered a portal to men's health. Treatment for erectile dysfunction should involve corresponding treatment of underlying metabolic syndrome conditions and hypogonadism.

SERUM BIOMARKERS OF ENDOTHELIAL FUNCTION AND OXIDATIVE STRESS AFTER DAILY DOSING OF SILDENAFIL IN TYPE 2 DIABETIC MEN WITH ERECTILE DYSFUNCTION (Abstract 955)

It is known that erectile dysfunction (ED), particularly in diabetic men, is often characterized by increased oxidative stress and decreased endothelial function. Johns Hopkins researchers investigated whether daily long-term sildenafil treatment can provide vasculoprotective effects in these patients in a multi-center, randomized, double-blind, placebo-controlled two-arm study. Using a group of 300 men with documented ED and type 2 diabetes mellitus, researchers measured serum biomarkers for endothelial function (cyclic guanosine monophosphate, or cGMP) and oxidative stress (8 isoprostane). Inflammatory cytokines were measured using Bio-Plex suspension array sytem assays for interleukin-6 and interleukin-8. Erectile dysfunction was measured based on affirmative responses to question 4 of the Sexual Health Inventory-Male which asks about a patient's ability to maintain an erection for sexual intercourse.

Endothelial function increased and oxidative stress decreased in the treatment group with no significant change noted in the placebo group. Erectile function improved in the treatment group with 22.8 percent at baseline and 58.2 percent at four weeks. Statistically significant change was not observed in the placebo group with 27.8 percent at baseline vs 30.7 percent at four weeks.

BODY MASS INDEX AFFECTS THE RESPONSE TO SILDENAFIL IN MEN WITH MODERATE AND SEVERE LOWER URINARY TRACT SYMPTOMS (Abstract 1161)

A known link has been established between erectile dysfunction (ED) and cardiovascular risk factors such as obesity. A link has also been suggested between these factors and lower urinary tract symptoms (LUTS). This study from researchers in Chicago and New York analyzed a multi-center, double-blind, placebo-controlled study of men explores the connection between body mass index (BMI) and response to sildenafil in patients with ED and LUTS.

Men with scores less than or equal to 25 on the Erectile Function domain of the International Index of Erectile Funcation and an International Prostate Symptom Score greater or equal to 12 were given 50 mg of sildenafil (or matching placebo) nightly or one hour before sexual activity. After two weeks, dose was increased to 100 mg with the option of returning to the original dose. Patients were evaluated for erectile function, IPSS and flow rate (Qmax) and assessed by BMI category. Sildenafil improved erectile function scores independent of baseline BMI and IPSS scores were decreased in men taking sildenafil yet similar between BMI groups. Flow rate was not affected by the drug. Higher BMI appeared to have an association with more severe ED.

NEPHROLITHIASIS AND THE RISK OF CARDIOVASCULAR DISEASE (Abstract 1362)

Stone disease is a urologic condition whose etiology has not been completely characterized. Researchers in San Francisco and Boston have hypothesized a connection between stone disease and cardiovascular disease (CVD) in a large-cohort prospective analysis of 4,747 patients with a history of nephrolithiasis. CVD was defined as myocardial infarction, angina, need for coronary artery bypass graft and ischemic or hemorrhagic stroke.

Risk of CVD in men with a history of nephrolithiasis was 1.15; the risk was highest for angina among individual outcomes analyzed. No increased stroke risk was observed. While the statistical risk for CVD in stone disease patients was modest, results correlate with other studies investigating a link between CVD and nephrolithiasis and may contribute to the etiology of stone formation and the counseling of patients.

GENERAL OBESITY AS MEASURED BY WAIST CIRCUMFERENCE IS PREDICTIVE OF SEVERITY OF LOWER URINARY TRACT SYMPTOMS, SEXUAL DYSFUNCTION AND COMPONENTS OF THE METABOLIC SYNDROME (Abstract 1508)

Increased body mass index (BMI) and other components of metabolic syndrome have been linked to a number of urologic disorders, including erectile and voiding dysfunction. Researchers from New York and Illinois suggest that measurement of waist circumference may be a useful predictor for the severity of lower urinary tract symptoms (LUTS) and prostate volume. Baseline parameters - International Prostate Symptom Score (IPSS), prostate volume (measured by ultrasound), serum prostate-specific antigen (PSA), flow rate and erectile and ejaculatory dysfunction - were gathered, along with data on the incidence of hypertension, coronary artery disease and diabetes mellitus were compared among the 88 men in the study. Men were divided into three groups based on waist circumference (30-36 inches, 36-40 inches and greater than 40 inches).

Significant positive relationships between waist circumference and prostate volume, PSA, IPSS, erectile dysfunction and ejaculatory dysfunction were observed. Flow rates were inversely related. Higher waist circumference was also associated with an increase in diabetes mellitus, hypertension and coronary artery disease. These data suggest that increased waist circumference is associated with voiding and sexual dysfunction, and increase in metabolic syndrome disorders.

No Need To Whisper: Talking And Treating Erectile Dysfunction

The conversation about male sexual dysfunction has grown from a whisper to a roar. From Bob Dole to Mike Ditka, erectile dysfunction, or ED, is no longer hush-hush as more men are talking more openly. Non-stop commercials convey help in the bedroom is just a prescription away. And while some 35 million men in this country have found a renewed sex life thanks to the "little blue pill," Temple urologist Jack Mydlo says men can improve their performance without a visit to the doctor or a drugstore.

"The last thing I want them to do is take a pill and jump in bed because a certain part of the mechanism for erections is psychological. They have to be in the right mood, with the right person and take care of themselves" said Mydlo, MD, professor and chair of the department of urology at the School of Medicine.

Surprisingly, a good percentage of men who seek medical help aren't even in a relationship.

"About thirty percent of the men who have a penile prosthesis don't even have a partner," said Mydlo. "They're putting the cart before the horse, so to speak, and think they'll get a partner once they have the implant.

Instead, Mydlo offers simple tips this Valentine's Day to turn a man's potency from terrible to terrific.

Stop smoking

Diabetes and high blood pressure restrict blood flow to the penis, leading to erectile dysfunction. But if you can rule those conditions out as causes of ED, the next culprit in line is cigarettes. "The number one thing we can do to stop erectile dysfunction is to stop smoking. It's the number one environmental cause of ED in our society," says Mydlo. Again, smoking restricts blood flow. The catch? Don't expect better erections the minute you stop lighting up. He says it takes 12 to 24 months for better function once you quit the habit.

Control cholesterol

Cholesterol is a trigger of sorts for ED. "Men with a cholesterol level of 240 or higher have almost a twofold increase of ED compared to a man who has lower cholesterol numbers," says Mydlo. That's because high levels of cholesterol lead to plaque buildup in tubes (corpa cavernosa) in the penis and arteries, which can greatly reduce blood flow. And no blood flow means no erection. So start exercising and check with your doctor about cholesterol-lowering medications.

Cut back on fat

Obesity is to blame not only for men with self-esteem issues involving their appearance, but also their performance. "Adipose tissue in body fat converts testosterone to estrogen, and lower levels of testosterone can make it difficult for a man to achieve an erection, no matter how many pills they take," says Mydlo. Losing weight will improve the testosterone to estrogen ratio, which may improve sex drive, or libido, as well as erections. It also decreases cholesterol, which will help improve blood flow.

For some of the 18 million men who have erectile dysfunction, these three tips may do the trick. For others, Mydlo suggests a visit to a urologist to go over options, ranging from pumps to implants to pills, like Viagra®, Cialis®,and Levitra.® There is one factor, though, that Mydlo can't help with but Cupid probably can: finding the right mate.

"They believe if they don't have good sexual function, who is going to want them? But the truth is, if you don't have a mental connection with your partner, everything will be for naught."