Tuesday, July 26, 2005

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.
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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

Thursday, July 21, 2005

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 )