BiDil(R) Data to be Presented at American Heart Association Scientific Sessions

American Heart Association's Scientific Sessions 2005
BIOWIRE2KDALLAS--(BUSINESS WIRE)--Nov. 11, 2005--NitroMed, Inc. (NASDAQ: NTMD) announced today that it will present several oral abstracts that feature post-approval analyses of BiDil(R) (isosorbide dinitrate/hydralazine HCI) data from the Company's landmark African American Heart Failure Trial (A-HeFT), at the American Heart Association's Scientific Sessions 2005, being held from November 13 - 16 in Dallas. BiDil was approved in June of this year by the U.S. Food and Drug Administration for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients.
The BiDil data to be presented further substantiate A-HeFT trial results, which demonstrated that the patients taking BiDil had significantly improved survival, prolonged time to hospitalization for heart failure and substantial improvement in patient-reported functional status, versus those patients who received placebo. The abstract presentations address the questions of: how does BiDil effect patient ventricular function; how is clinical benefit correlated with a blood pressure lowering effect of BiDil; how substantial are the financial savings to the health care system of using BiDil (decreased hospitalizations); and how does BiDil impact patients' quality of life.
The A-HeFT related oral abstracts will be presented during a scientific session titled "Heart Failure: Substudies From Larger Trials" (AOP.60.1), taking place at the Dallas Convention Center on Tuesday, November 15th, from 2:00 to 5:00 pm. The relevant titles follow, and all four will be presented in room C3 at the Dallas Convention Center.
-- Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Inhibits Left Ventricular Remodeling in Well-Treated Severe Heart Failure in African-Americans (3:00 pm)
-- Beneficial Effects of Isosorbide Dinitrate-Hydralazine on Survival in Heart Failure is Independent of its Blood Pressure Lowering Effect (3:45 pm)
-- Cost-Effectiveness of Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Therapy for Black Patients with Heart Failure (4:30 pm)
-- Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Improves Quality of Life in African Americans with Heart Failure (4:45 pm)
Notably, A-HeFT data will also be highlighted during a Circulation-sponsored symposium titled "Groundbreaking Studies in the Practice of Cardiovascular Medicine - Circulation Editors' Choices for 2004-2005" (Sunday Morning Program #12). During this symposium, being held on November 13th, Dr. Anne Taylor, Professor of Medicine at the University of Minnesota and chairperson of the A-HeFT steering committee, will present BiDil results in a talk titled "The Combination of Isosorbide Dinitrate and Hydralazine in Black Patients with Heart Failure."
BiDil was commercially launched by NitroMed in July 2005. The FDA based the approval of BiDil primarily on results from the A-HeFT trial, which was halted early, in July 2004, due to the significant survival benefit seen with the drug.
NitroMed plans to submit the left ventricular remodeling data presented today to the FDA before year-end, as a supplement to the data that formed the basis of BiDil's regulatory approval.
Manuel Worcel, M.D., F.A.H.A., Chief Medical Officer of NitroMed commented, "As exemplified by our four oral abstract presentations at AHA, scientific and medical community interest in BiDil remains strong. The A-HeFT database continues to be a valuable resource to help us further understand the mechanism and usefulness of BiDil, as we look ahead to the best ways to expand our BiDil franchise and cardiovascular product offerings."
About BiDil
BiDil is indicated for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients, to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status. There is little experience in patients with New York Heart Association (NYHA) class IV heart failure. Most patients in the clinical trial supporting effectiveness, referred to as A-HeFT, received, in addition to BiDil or placebo, a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
BiDil is a fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride. While the exact mechanism of action underlying the beneficial effects of BiDil in the treatment of heart failure is unknown, it is known that isosorbide dinitrate is a vasodilator with effects on both arteries and veins. The dilator properties of nitrates result from the release of nitric oxide that leads to the relaxation of vascular smooth muscle. Hydralazine is an arterial vasodilator.
In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies experienced a significant 43 percent decrease in the risk of mortality (P=.012) (absolute mortality rate: BiDil, 6.2% vs. placebo, 10.2%), a 39 percent reduction in the risk of first hospitalization for heart failure (P less than .001) (absolute first hospitalization rate: BiDil, 16.4% vs. placebo, 24.4%) and a statistically significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire, which is a self-report of the patient's functional status, versus patients taking placebo in addition to current standard therapies.
Heart Failure Burden in Black Patients
Heart failure, or end-stage cardiovascular disease, affects approximately five million Americans, including an estimated 750,000 African Americans. Each year, over 550,000 people are diagnosed with heart failure for the first time, and there is no cure for this disease - with more than 50 percent of patients dying within five years of diagnosis. With respect to heart failure, blacks are affected at a rate greater than that of the corresponding non-black population, presenting with the disease earlier and dying sooner. According to the Centers for Disease Control and Prevention (CDC), African Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range.
Important Safety Information
BiDil is contraindicated in patients who are allergic to organic nitrates. Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors (e.g., Viagra(R)/RevatioTM, Levitra(R), Cialis(R) could result in severe hypotension.
Treatment with hydralazine may produce a clinical picture simulating systemic lupus erythematosus (SLE) including glomerulonephritis. If SLE-like symptoms occur, discontinuation of BiDil should be considered. Residua have been detected many years after discontinuation of hydralazine. Symptomatic hypotension may occur with even small doses of BiDil. BiDil should be used with caution in volume depleted or hypotensive patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness and tingling, which may be related to an antipyridoxine effect. Caution should be exercised if BiDil is used with MAO inhibitors, alcohol, sildenafil, vardenafil or tadalafil.
Headache (50%) and dizziness (32%) were the two most frequent adverse events and were more than twice as frequent in the BiDil group.
Viagra is a registered trademark and Revatio is a trademark of Pfizer, Inc.; Levitra is a registered trademark of Bayer HealthCare, GlaxoSmithKline, and Schering-Plough; Cialis is a registered trademark of Lilly ICOS LLC.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is a research-based emerging pharmaceutical company and the maker of BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine that may be prescribed in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. BiDil was approved by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark A-HeFT (African American Heart Failure Trial) clinical trial, and is marketed by NitroMed through a nationwide, dedicated sales force.
The Company is committed to the development of novel pharmaceuticals and safer, more effective versions of existing drugs to treat underserved patient populations. NitroMed's development efforts are primarily directed at expanding its cardiovascular franchise.
Forward Looking Statements
Statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's expectations about the new clinical data regarding BiDil, the benefits of BiDil and its plans to make BiDil available to patients who can gain from its therapeutic benefits, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: unanticipated difficulties in obtaining regulatory approval with regard to new clinical data, maintaining existing regulatory approvals to market and sell BiDil; the Company's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; adverse side effects experienced by patients taking BiDil; the Company's ability to obtain or maintain intellectual property protection and required licenses; the Company's ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil and other factors discussed in its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2005, which is filed with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
For full prescribing information, visit: http://www.bidil.com/.
BiDil is a registered trademark of NitroMed, Inc.

Double the pleasure

Treating his sexual woes also boosts her satisfaction
By Brian Alexander
MSNBC contributor
Updated: 3:31 p.m. ET Nov. 10, 2005
When Dr. Irwin Goldstein, a well-known expert in sexual medicine, presented recent research findings to a scientific meeting, he said: “It is rare for me to stand in front of an audience and say, ‘This is a manuscript that has changed my life.' But this one has done that.”
At first glance the study, printed in the Journal of Sexual Medicine (edited by Goldstein), seems like the most obvious thing in the world. When you hear the results, you say to yourself, “Well, duh!”
The results showed that female sexual partners in committed relationships with men who were treated with an impotence drug (in this case Levitra, made by Bayer, which also sponsored the study) had better sex. That’s the “duh” part. But get this: The women didn’t just like sex better because they could, you know, have sex. They liked sex better because their own bodies worked better. Lubrication improved. Orgasm improved. Desire improved.
In case you’re still not catching on, the women’s bodies reacted as if they were receiving the drug, as if they were the ones being treated. So a drug they didn’t even take affected their bodies.
“Her physiology is linked to him,” Goldstein says. “Men share problems with women, and the solutions … It totally intrigues me. I can change someone’s physiology without treating them. It’s the wildest thing!”
In fact, the better a man’s response to the drug, the better her response to him.
There’s a concept in the world of physics called “entanglement.” It refers to the weird fact that subatomic particles have “partners” — other subatomic particles — with which they can be entangled, sometimes over great distances. If a physicist tinkers with one particle, the change affects the other particle. Strange but true.
I find Goldstein’s study a strong indicator that humans can be entangled, that the romantic ideal extolled by poets and Dr. Phil exists in real life. We really do change when we fall in love. We become a unit, at least sexually. “There are no other physiologic abilities of men and women that are shared, and that is what is so fascinating about these data,” Goldstein says.
One sexual unit?He is reluctant to speculate beyond his data, but when I asked if he knew if the effect could work the other way, he says that he has some evidence that when he successfully treats women who suffer from dyspareunia, or pain with intercourse, their men get better erections and have more sexual satisfaction. And he suspects that male partners of women with low libido have poorer erections and that if those women could be treated, the men would improve, too.
Is this really possible? Do we really meld into one sexual unit?
Could be, says Jerry Phelps, a psychologist at the University of California, San Diego, who has studied and treats couples with sexual problems.
When Phelps worked with postmenopausal women who were counseled on the changes they might experience, given treatment options for any sexual dysfunction, and taught how to talk it all over with their partners, both partners benefited.
Phelps, who also treats young people at the school’s counseling center, says the theory isn’t just for middle-aged marrieds. “I would like to see joint treatment in most cases [of sexual dysfunction]," he says. “I would encourage the partner to be included,” whether the caregiver is a psychologist, psychiatrist, urologist or ob-gyn.
'A couple's condition'Goldstein says much of the existing paradigm for treating sexual dysfunction “is hopeless! It is penis-focused, male-oriented. There’s no involvement of the couple. That must change. Correct management is to treat this as a couple’s condition.”
He suggests using infertility medicine as an example. “When people cannot have a child," he says, "the medical conclusion is you must evaluate both members. But when a man has erectile dysfunction, we’re only treating the man!”
He’s not just being a romantic, either. One of the findings of his research is that in addition to all the good stuff that happened to the female partners of men treated for impotence, they also suffered more pain with intercourse than they did before the drug gave their man the woody of a titan. So by treating both people, women could be counseled on what to expect and ways to prevent pain.
I am not a scientist, nor a medical doctor, so I’m perfectly willing to go beyond the data to speculate on what’s going on, and here’s what I think. I think, and the questions submitted over and over again to Sexploration show, that people in long-term, committed relationships really are “entangled” in most if not all aspects of life.
It's always about youThis might seem obvious, yet we often deny it. We use the phrase “It’s not about you,” when we talk to our partners, but it’s ALWAYS about them. If we change jobs, it’s not just us being affected. If we suddenly feel depressed, we’re not the only ones suffering. Sexually speaking, if we gain lots of weight, dress like a slob, it’s not just about us. We don’t have to look at ourselves.
Accepting the joys of love — great sex being one — also means recognizing the responsibilities and one of those responsibilities is keeping yourself appealing to your partner. Sounds shallow, yes. But doing it shows you care about your partner. Your partner gains self-esteem as you do. Your partner loses it when you do. He feels sexy when you do. She feels in the mood when you do.
“This is intuitive, yes,” says Goldstein. “But that is what’s intriguing, that this is part of a relationship, the sharing of psychological issues. We get into each other's head.”
When Viagra first came out, Goldstein recalls, Pfizer was surprised that, even though the drug was a blockbuster, sales were lower than expected. Turned out many men with impotence weren’t going to get it on their own. Those who did were often spurred by their wives who recognized that his sexual problem was her problem, too.
So remember, it’s not only that we want to get into each other’s pants. It’s that we already inhabit them.
Brian Alexander is a California-based writer who covers sex, relationships and health. He is a contributing editor at Glamour and the author of "Rapture: How Biotech Became the New Religion" (Basic Books).
Sexploration appears every other Thursday.
© 2005 MSNBC Interactive


URL: http://msnbc.msn.com/id/9979638/

Over time, use of common ADD medication stalls sex drive

Q: I was recently married. I am 39, my husband is 42, and we are having some trouble. My husband takes Adderall for ADD and has zero sex drive.He says he has felt this way for many years, due to the medication. (He's been on Adderall for almost 10 years.)We've tried Viagra and Cialis. They help his erectile dysfunction but do nothing for his libido. How can we improve his desire for sex?
I am feeling frustrated and hurt because he doesn't seem to desire me at all. Do we have a chance for a normal sex life?A: Adderall (mixed amphetamines) is used to treat a sleeping disorder called narcolepsy as well as attention-deficit disorder (ADD). Initially, amphetamine may increase sex drive, but over time interest in sex may diminish. Impotence is also a potential side effect.
Drugs like Viagra, Levitra and Cialis don't affect libido, so we're not surprised they did not improve his desire. Unless he can find a different way to deal with his ADD, it may be difficult to solve this problem.An endocrinologist can test to see if his testosterone levels are low. If so, he might benefit from hormonal replacement.Q: My doctor told me to use Prelief (calcium glycerophosphate) for interstitial cystitis. It does work. The nurse said it is natural and has no side effects. That seems too good to be true.
A: Interstitial cystitis is a painful bladder condition that may be aggravated by acidic foods like coffee, orange juice and tomato sauce. Prelief reduces acid in such foods to relieve symptoms associated with interstitial cystitis, overactive bladder or heartburn. We know of no side effects, but you can get more information at 1-800-994-4711 or www.prelief.com.Q: Why do doctors put patients on sleeping pills for years? A friend has taken Ativan for a long time and is now addicted. She is not the same person she once was.
A: Sleeping pills can seem like a simple solution for insomnia, but drugs like Ativan (lorazepam), Dalmane (flurazepam), Halcion (triazolam), ProSom (estazolam), Valium (diazepam) or Xanax (alprazolam) may lead to dependence. Sudden discontinuation can cause rebound sleeping problems as well as other symptoms (agitation, anxiety or tremor). Short-acting drugs like lorazepam or triazolam may be especially problematic. Gradually withdrawing over weeks or months may work.We are sending you our Guides to Getting a Good Night's Sleep and Psychological Side Effects, which provide more information on getting off sleeping pills. Anyone who would like copies, please send $3 in check or money order with a long (No. 10), stamped (60 cents), self-addressed envelope to: Graedons' People's Pharmacy, No. IM-7, P.O. Box 52027, Durham NC 27717-2027.
Write to Dr. Joe and Teresa Graedon in care of King Features Syndicate, 888 Seventh Ave., New York NY 10019, send e-mail to peoplespharmacy@gmail.com or visit http://www.peoplespharmacy.org/.


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Health Canada Issues Advisory Re: Viagra-Related Vision Problems

OTTAWA -- Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible. Risk factors for NAION include:* age greater than 50 years* heart disease* high blood pressure* high cholesterol* diabetes* smoking* certain pre-existing eye problemsAn article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.© Copyright 2004 by HalifaxLive.com

Ellen Goodman: Life vs. lifestyle

12:07 AM CDT on Tuesday, July 26, 2005
Remember when Viagra first came on the market? The spokesman was Bob Dole, veteran, Senate leader, and prostate cancer survivor, who urged other men to talk to their doctors about erectile dysfunction. The slogan was: courage.
Balance of Opinion
In addition to the syndicated national columnists who regularly appear on Viewpoints, we are offering readers more voices in this twice-weekly roundup, on Tuesdays and Fridays, of comments from the country's leading political commentators.Read the complete columns at DallasNews.com.
Fast forward through the millennium. The spokesman now is a hunky 40-something guy with a two-day-old beard and a slogan that says: ''Keep that spark alive."
The message today is less about disease and more about delight. We've seen ads for erectile dysfunction drugs that feature one man throwing a football through a swinging tire – say, what? – and another getting his mojo back while window-shopping for lingerie. We have a leading lady oozing her satisfied testimonial to Levitra's ''strong and lasting" effects. We have romantic scenes with the Cialis tagline: ''When the time is right, will you be ready?"
The only warning missing from the stream of side effects listed in these ads was to the drug companies themselves. Beware: If you pitch Viagra, Cialis, and Levitra as lifestyle drugs, you can't complain when they get targeted as lifestyle drugs.
It shouldn't have been a surprise when the House of Representatives voted to ban Medicare and Medicaid payments for erectile dysfunction drugs. It happened soon after the brain-numbing news that 800 sex offenders in 14 states had been given Viagra under Medicaid. Paying for Viagra for sex offenders is like funding assault weapons for impoverished felons. But in this case, the vote was less about sexual abuse than sexual recreation.
As Representative Steve King of Iowa put it, ''We provide drugs through Medicare and Medicaid that are lifesaving drugs; we don't pay for lifestyle drugs." We can't tell taxpayers, he added, ''we're going to take the money you earned on overtime to pay for Grandpa's Viagra."
Now sex is ready to rear its head in the Senate version of the spending bill. Is it possible to have a rational conversation about rationing?
At the heart of it, this is a conversation about rationing disguised as a conversation about lifestyle drugs. I don't know anyone who thinks the government should pay for hair replacement drugs, nail fungus treatments, or cosmetic surgery. But what exactly is a lifestyle drug? Is there a difference between medicine that enhances our ''lifestyle" and our ''quality of life," and our life itself?
King said Medicare and Medicaid are only for life-saving drugs. But where do we draw that line? A drug that reduces the nausea from chemo doesn't save lives. Reconstructive breast surgery after a mastectomy doesn't save a life. A nose job to meet beauty standards may be a lifestyle choice, but what about a nose job after a car accident? When is a cataract operation lifesaving and when is it ''merely" life-enhancing?
While we are on the subject, if you lose your sense of taste, should the public pay for a cure? How is that pleasure different from sexual pleasure? Bioethicist Art Caplan calls the debate about Grandpa and Viagra ''Puritanism masquerading as medicine." It seems that a Congress that can't even negotiate prices with the drug companies has no trouble whatsoever with values-based rationing.
There are many, like Jonathan Weiner, a health policy professor at Johns Hopkins, who believe ''we should not be paying for sex for elders as long as we aren't paying for basic coverage for everyone." But the issue of coverage for everyone isn't even on the table.
While we talk about cost containment for sex, we haven't even begun to think about what we'll do with the truly expensive drugs coming down the pike. Some of the new cancer treatments can cost $100,000 in order to prolong life for a few weeks or months. How does a country divided over Terri Schiavo's fate wrestle over the cost of that ''lifesaving" healthcare?
I have no interest in using my tax dollars so a perfectly normal 70-year-old can be ready whenever ''the time is right." On the other hand, sex is not just a Cialis ad. One of the reasons why many men close their eyes to prostate cancer is the fear of impotence. It's possible and sensible to distinguish between the dysfunction caused by disease and the superfunction that urges 70-year-olds to behave like 40-year-olds. We can fund one and not the other.
For the moment, drug companies have produced their own advertising blowback. It's too easy to attack the notion of government-funded sex. But anyone who embraces the matter of healthcare costs and choices had better remember the very first tagline on this subject: courage.
Online at: http://www.dallasnews.com/sharedcontent/dws/dn/opinion/balance/stories/072605dnedicybergood.c713beb.html

Lilly ICOS LLC Reports Results for Second Quarter of 2005

Lilly ICOS LLC Reports Results for Second Quarter of 2005 - Quarterly net loss narrows to $1.7 million - - Worldwide sales of Cialis(R), since launch, exceed $1 billion -Thursday July 21, 7:00 am ET
BOTHELL, Wash. and INDIANAPOLIS, Ind., July 21 /PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: ICOS) is releasing its financial results for the second quarter ended June 30, 2005. The Company has advanced to the point where it is on the cusp of profitability as a result of sustained sales growth and reductions in marketing and selling expenses. Worldwide sales of Cialis® (tadalafil)(1) in the second quarter of 2005 totaled $190.9 million, an increase of 39% compared to $137.2 million in the second quarter of 2004. U.S. sales of Cialis were $71.1 million in the second quarter of 2005, compared to $50.8 million in the second quarter of 2004.
Cialis Net Sales (unaudited):
----------------------------
(in millions)
Three Months Ended Six Months Ended
June 30, June 30,
------------------ ----------------
2005 2004 2005 2004
-------- -------- -------- -------
Lilly ICOS Territories:
United States 71.1 $50.8 $113.9 $83.6
Europe (2) 60.9 45.3 117.2 81.6
Canada and Mexico 13.8 8.9 26.0 14.8
-------- -------- -------- -------
Total Lilly ICOS 145.8 105.0 257.1 180.0
Lilly Territories 45.1 32.2 84.0 65.5
-------- -------- -------- -------
Worldwide Total $190.9 $137.2 $341.1 $245.5
======== ======== ======== =======
"It is exciting that, in 2005, cumulative worldwide sales of Cialis passed the $1 billion mark," stated John Bamforth, Lilly Global Marketing Director. "The progress we have made supports our long-standing belief that men value the benefits that Cialis offers."
Paul Clark, ICOS Chairman, President and CEO stated, "The global launches of Cialis have been successful. Our strategic plan has focused on gaining market share. In the U.S., market share of total prescriptions of Cialis increased 160 basis points in the second quarter of 2005, compared to the previous quarter, to 22.7%(3). In every major Lilly ICOS market, Cialis has far surpassed Levitra® (vardenafil HC1). Additionally, Cialis has passed Viagra® (sildenafil citrate) in a number of countries, including France -- and is closing in on it in several others. Cialis captured 31.7% of aggregate market share across Europe, Canada and Mexico in May 2005."(4)
Financial Results
For the three months ended June 30, 2005, Lilly ICOS reported a net loss of $1.7 million, compared to a net loss of $70.5 million for the three months ended June 30, 2004. The decreased net loss results from an increase of $43.4 million in total revenue, combined with a $25.4 million reduction in total expenses.
Total revenue for the second quarter of 2005 was $154.9 million, compared to $111.4 million for the second quarter of 2004. Revenue for the 2005 period includes $9.0 million in royalties on sales reported by Lilly, compared to $6.4 million in royalty revenue for the second quarter of 2004. The increase in overall Lilly ICOS revenue reflects the continued growth of Cialis in the Lilly ICOS territories since its 2003 introduction, as well as its global expansion in countries where it is sold by Lilly.
In December 2004, Lilly ICOS began to reduce U.S. wholesaler inventories of Cialis to targeted levels and, by early February 2005, was party to new agreements with its U.S. wholesalers. As a result, it is estimated that approximately $27 million of U.S. wholesaler inventory reductions of Cialis occurred during the first quarter of 2005. No significant additional wholesaler inventory reductions are anticipated.
Selling, general and administrative expenses decreased $31.6 million from the second quarter of 2004, to $126.2 million in the second quarter of 2005. The decrease is primarily due to the planned higher level of sales and marketing expenses, in the first half of 2004, following the November 2003 U.S. launch of Cialis.
Research and development expenses were $18.4 million in the second quarter of 2005, compared to $15.1 million in the second quarter of 2004. The increase is primarily due to incremental costs associated with pursuing additional indications for tadalafil, including benign prostatic hyperplasia and pulmonary arterial hypertension.
For the six months ended June 30, 2005, Lilly ICOS reported a net loss of $43.4 million, compared to a net loss of $209.3 million for the six months ended June 30, 2004. The decrease is due to increases in Lilly ICOS revenues since the 2003 Cialis launch and a reduction of sales and marketing expenses.
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture equally owned by ICOS Corporation and Eli Lilly and Company, is marketing Cialis for the treatment of erectile dysfunction in North America and Europe.
ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is working to develop treatments for serious unmet medical conditions such as benign prostatic hyperplasia, pulmonary arterial hypertension, cancer and inflammatory diseases.
Eli Lilly and Company, 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, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. F-LLY
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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.
The forward-looking statements contained in this press release represent ICOS' and Lilly's judgments as of the date of this release. Neither ICOS nor Lilly undertake any obligation to update any forward-looking statements.
-Selected financial data follows-
Lilly ICOS LLC
Condensed Consolidated Statements of Operations
(in thousands)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
-------------------- --------------------
2005 2004 2005 2004
--------- --------- --------- ---------
Revenue
Product sales, net $145,882 $105,000 $257,076 $180,017
Royalties 9,010 6,449 16,800 13,101
--------- --------- --------- ---------
Total revenue 154,892 111,449 273,876 193,118
--------- --------- --------- ---------
Expenses
Cost of sales 11,934 8,982 21,686 15,555
Selling, general and
administrative 126,232 157,838 263,259 352,891
Research and
development 18,413 15,119 32,287 33,946
--------- --------- --------- ---------
Total expenses 156,579 181,939 317,232 402,392
--------- --------- --------- ---------
Net loss $(1,687) $(70,490) $(43,356) $(209,274)
========= ========= ========= =========
Lilly ICOS LLC
SUMMARIZED OPERATING RESULTS
(in thousands)
(unaudited)
2005
---------------------------------
Q1 Q2 TOTAL
--------- ---------- ----------
Revenue:
Product sales, net:
United States $42,744 $71,118 $113,862
Europe 56,264 60,925 117,189
Canada and Mexico 12,186 13,839 26,025
--------- ---------- ----------
111,194 145,882 257,076
Royalties 7,790 9,010 16,800
--------- ---------- ----------
Total revenue 118,984 154,892 273,876
--------- ---------- ----------
Expenses:
Cost of sales 9,752 11,934 21,686
Selling, general and
administrative 137,027 126,232 263,259
Research and development 13,874 18,413 32,287
--------- ---------- ----------
Total expenses 160,653 156,579 317,232
--------- ---------- ----------
Net loss $(41,669) $(1,687) $(43,356)
========= ========== ==========
Lilly ICOS LLC
SUMMARIZED OPERATING RESULTS
(in thousands)
(unaudited)
2004
-------------------------------------------------
Q1 Q2 Q3 Q4 TOTAL
-------- -------- -------- -------- ---------
Revenue:
Product sales, net:
United States $32,807 $50,768 $70,226 $52,783 $206,584
Europe 36,356 45,301 43,414 52,859 177,930
Canada and Mexico 5,854 8,931 9,380 13,063 37,228
-------- -------- -------- -------- ---------
75,017 105,000 123,020 118,705 421,742
Royalties 6,652 6,449 6,210 6,809 26,120
-------- -------- -------- -------- ---------
Total revenue 81,669 111,449 129,230 125,514 447,862
-------- -------- -------- -------- ---------
Expenses:
Cost of sales 6,573 8,982 10,173 10,338 36,066
Selling, general
and administrative 195,053 157,838 123,222 130,398 606,511
Research and
development 18,827 15,119 17,203 16,169 67,318
-------- -------- -------- -------- ---------
Total expenses 220,453 181,939 150,598 156,905 709,895
-------- -------- -------- -------- ---------
Net loss $(138,784) $(70,490) $(21,368) $(31,391) $(262,033)
======== ======== ======== ======== =========
(1) Cialis® is a registered trademark of Lilly ICOS LLC. All other trademarks are the property of their respective owners.
(2) Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
(3) IMS Health, IMS National Prescription Audit Plus(TM), (based on total prescriptions) April, May and June 2005.
(4) Based on calculations using IMS Health, IMS MIDAS (PDE5 inhibitor tablets from wholesalers to pharmacies) May 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )

Medicaid coverage of Viagra halted

Medicaid coverage of Viagra haltedSex offenders' use gives state pauseBy AMY GARDNER, Staff WriterThe state has stopped paying for Viagra and other drugs that treat erectile dysfunction after finding that 15 convicted sex offenders received the pills through Medicaid.
State health officials discovered the offenders after news accounts of similar discoveries in other states. They suspended the coverage last week, and state lawmakers quickly began drafting legislation to keep Viagra and similar therapies off-limits to sex offenders.
"It is just abhorrent that we would run the risk of any sex offender receiving the drug," said Carmen Hooker Odom, North Carolina's secretary of health and human services.
Last fiscal year, North Carolina's Medicaid program -- which provides health insurance for poor residents -- filled more than 41,000 prescriptions for erectile-dysfunction drugs at a cost of nearly $800,000.
That figure is a small fraction of the $1.4 billion that North Carolina and the federal government spent on prescription drugs for Medicaid patients in the state last year.
Still, it warrants closer attention, lawmakers said, particularly in a year when legislative leaders ordered up to $100 million in cuts in Medicaid to offset the program's spiraling spending increases.
Some lawmakers were surprised to learn that taxpayers were helping pay for erectile dysfunction drugs at all. Edd Nye, a Bladen County Democrat and co-chairman of the House Appropriations Committee, said such "recreational" drugs ought not be covered.
"I didn't know we were paying for it, and I'm glad we stopped it," Nye said. "Maybe we could keep it stopped."
State Sen. Linda Garrou, a Democrat from Winston-Salem and a co-chairwoman of the Senate Appropriations Committee, is drafting a bill that would ban Medicaid coverage of erectile-dysfunction drugs for sex offenders.
State officials say it is too cumbersome for medical providers to distinguish patients who are sex offenders from other Medicaid recipients. To keep from supplying the drugs to sex offenders, the state would have to ban Medicaid coverage for all patients, including law-abiding men with medical conditions that cause dysfunction, such as prostate cancer or diabetes.
Hooker Odom said she's comfortable banning all coverage. Medicaid paid for only two pills a month before the temporary suspension. At about $10 apiece, Hooker Odom is willing to pass along that cost to those men who wish to continue using the drug.
Pharmacy benefit managers often classify Viagra as a lifestyle drug that does not treat a life-threatening disease. According to a study published in 2000 in the Archives of Internal Medicine, only 40 percent of men taking Viagra for the first time have previously been treated for erectile dysfunction. Such data suggest that not all men receiving Viagra or similar drugs through Medicaid have a medical condition warranting it.
Controlling costs
Overall, North Carolina spends $7.1 billion a year on Medicaid. The program's prescription drug costs have been difficult to rein in. Among the reasons: the political influence of the pharmaceutical industry, and evidence that spending more on drugs can reduce other costs such as emergency room visits and hospitalizations.
For example, the state spent $11 million on contraceptives last year -- but would have spent even more on pregnancy care and childbirth if contraceptives weren't covered.
Contraceptives, like drugs for erectile dysfunction, have always been covered under federal Medicaid laws.
It was only last month, after news reports that taxpayers were paying for sex offenders to take impotence pills, that federal Medicaid officials authorized states to put a stop to the practice.Staff writer Amy Gardner can be reached at 829-8902 or agardner@newsobserver.com.

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