Cialis Filed in European Union for Once-a-Day Dosing for Erectile Dysfunction; ICOS Expects Significant Acceleration of Earning
June 07 2006 - 7:14PM
Business Wire
ICOS Corporation (Nasdaq:ICOS) today announced that Lilly ICOS LLC,
its joint venture with Eli Lilly and Company (NYSE:LLY), has
submitted a regulatory filing for marketing approval to the
European Medicines Agency (EMEA) for Cialis(R) (tadalafil) 2.5 mg
and 5 mg once-a-day dosing to treat erectile dysfunction (ED).
Lilly ICOS plans to file in the United States and Canada later in
2006. If approved, the first launches could occur in late 2007. "We
are very excited about the prospect of bringing Cialis Once-A-Day
to the market in North America and Europe," stated Paul Clark, ICOS
Chairman and CEO. "Market research revealed that once-a-day therapy
could especially appeal to an important segment of the patient
population -- the man in his forties or fifties who takes a PDE5
inhibitor more frequently than average." Mr. Clark added,
"Importantly, growth in worldwide Cialis sales, including Cialis
Once-A-Day beginning in 2008 if approved, are expected to drive
accelerated earnings for ICOS Corporation." The recent EMEA filing
followed the completion of three Phase 3 clinical studies that
evaluated the efficacy and safety of Cialis when administered
once-a-day for the treatment of ED. Men with ED taking Cialis 5 mg
Once-A-Day experienced significantly improved erectile function
compared to those taking placebo. Cialis 5 mg Once-A-Day was
generally well-tolerated with most frequently occurring side
effects being upset stomach and headache. "Introducing the
once-a-day treatment for ED is part of our long range strategic
plan for maximizing the value of the tadalafil molecule," added
Leonard Blum, Senior Vice President, Sales and Marketing. "The
once-a-day dose would be priced less than the Cialis 10 mg or 20 mg
tablet, commonly used on-demand and, as a result, could be a
financially viable alternative to the current on-demand regimen."
Financial Outlook In order to provide some context as to the
potential value of Cialis Once-A-Day, ICOS is presenting its
expectations for future results. ICOS is assuming that Cialis
Once-A-Day will be approved in the United States, Europe, Canada
and Mexico, and will generate incremental sales beginning in 2008.
On May 4, 2006, ICOS stated its expectation that 2006 worldwide
Cialis product sales would be around $900 million, and Lilly ICOS'
2006 net income would be near the upper end of the $210 million to
$240 million range previously communicated. The Company also
indicated that it expected ICOS' 2006 full year GAAP net loss to be
near the low end of the $5.0 million ($0.08 per share) to $25.0
million ($0.39 per share) net loss range that it had previously
communicated. "We are delighted to discuss, for the first time, our
expected significant acceleration of earnings for ICOS Corporation
in 2007 and 2008," said Michael Stein, Senior Vice President and
Chief Financial Officer. ICOS Corporation currently expects its
2007 fully-taxed net income to be in the range of $35 million
($0.53 per diluted share) to $45 million ($0.68 per diluted share).
For 2008, ICOS Corporation's fully-taxed net income is presently
expected to be in the range of $85 million ($1.23 per diluted
share) to $100 million ($1.45 per diluted share). The expected 2007
and 2008 results of operations for ICOS Corporation are presented
on a fully-taxed basis, assuming a 35% effective income tax rate.
However, because of net operating loss carryforwards, the Company
does not expect that ICOS Corporation will recognize or pay
significant Federal income taxes in those years. ICOS anticipates
that 2007 worldwide Cialis product net sales may grow at or greater
than a mid-teens percentage rate, to in excess of $1 billion, and
expects a greater than 50% increase in Lilly ICOS' 2007 net income
compared to 2006. ICOS expects that 2008 worldwide total Cialis net
product sales (including once-a-day) may grow 20% to 25% over 2007,
and expects a 40% to 50% increase in Lilly ICOS' net income in 2008
compared to 2007. Expected results for Lilly ICOS do not include
any costs it might choose to incur as a result of a successful
outcome of the currently in process Phase 2 study of tadalafil in
hypertension. Conference Call ICOS will host a conference call, on
Thursday, June 8, 2006, at 8:30 a.m. Eastern Time, to discuss plans
for Cialis Once-A-Day and related matters, including information
regarding expected future results of operations. The conference
call can be accessed as a webcast at www.icos.com, in the
Investor/Events section, or by telephone, using the Passcode
832207, live at 480-629-9025, or as a replay at 320-365-3844. The
webcast will be available until June 15, 2006, at 9:30 a.m. Eastern
Time. The telephone replay will be available until June 9, 2006, at
8:00 p.m. Eastern Time. About ED ED is defined as the consistent
inability to attain and maintain an erection sufficient for sexual
intercourse. ED affects an estimated 189 million men worldwide(1).
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(2)(3). In many cases, however, both
psychological and physical factors contribute to the condition(4).
About Cialis Cialis(R) (tadalafil) is approved for the treatment of
erectile dysfunction, and is the only oral ED tablet clinically
proven to work up to 36 hours. Cialis is available by prescription
only and is not for everyone. Men taking nitrates, often used for
chest pain, should not take Cialis. Such a combination could cause
a sudden, unsafe drop in blood pressure. The most common side
effects with Cialis were headache, upset stomach, delayed backache
or muscle ache. As with any ED tablet, in the rare event of
priapism (an erection lasting more than four hours), men should
seek immediate medical attention to avoid long-term injury. Men
should not drink alcohol in excess with Cialis. Cialis does not
protect a man or his partner from sexually transmitted diseases,
including HIV. In rare instances, men taking prescription ED
tablets (including Cialis) reported a sudden decrease or loss of
vision. It's not possible to determine if these events are related
directly to the ED tablets or to other factors. If a man has a
sudden decrease or loss of vision, he should stop taking any ED
tablet and seek immediate medical attention. Men should discuss
their medical conditions and all medications with their doctors to
ensure Cialis is right for them and that they are healthy enough
for sexual activity. Individual results may vary. Cialis has not
been studied for multiple attempts per dose. For full patient
information and/or full prescribing information, visit
http://www.cialis.com. Tadalafil, the active ingredient in Cialis,
is also being evaluated for other medical conditions, such as
hypertension, benign prostatic hyperplasia (BPH) and pulmonary
arterial hypertension (PAH). About ICOS Corporation 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,
hypertension, pulmonary arterial hypertension, cancer and
inflammatory diseases. Additional information about ICOS is
available at www.icos.com. 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, including statements concerning anticipated
regulatory approvals of once-a-day dosing of Cialis and expected
future results of operations. In some cases, you can identify
forward-looking statements by terminology such as "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "possible," "potential," "predict,"
"should" or "will" or the negative of such terms or other
comparable terminology. Forward-looking statements are only
predictions that provide our current expectations or forecasts of
future events. These forward-looking statements involve risks and
uncertainties that may cause our results and the timing and outcome
of events to differ materially from those expressed in or implied
by the forward-looking statements, including risks associated with
product commercialization, research and clinical development,
regulatory approvals, manufacturing, collaboration arrangements,
liquidity, competition, intellectual property claims, litigation
and other risks detailed in our latest Quarterly Report on Form
10-Q and our other public filings with the Securities and Exchange
Commission. In particular, government regulatory authorities may
not approve once-a-day dosing of Cialis or may delay its approval.
Any failure to receive the regulatory approvals necessary to
commercialize once-a-day dosing of Cialis could harm our business.
Human therapeutic products are subject to extensive and rigorous
government regulation. In addition, we have only limited experience
in filing and pursuing applications necessary to gain regulatory
approvals, which may impede our ability to obtain such approvals.
The regulatory review and approval process is lengthy, expensive
and uncertain. Any FDA or other regulatory approval of our product
candidates, once obtained, may be withdrawn. Any or all of our
forward-looking statements in this press release and in any other
public statements that we make may turn out to be wrong. Inaccurate
assumptions we might make and known and unknown risks,
uncertainties and other factors may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
such forward-looking statements. Although we believe that the
expectations reflected in the forward-looking statements are
reasonable, based on the information available to us at the time
the statements are made, we cannot guarantee future results,
performance or achievements. You should not place undue reliance on
these forward-looking statements. The forward-looking statements
contained in this press release represent our judgment as of the
date of this release. Except as required under federal securities
laws and regulations, we undertake no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future events or otherwise. The biotechnology and
pharmaceutical businesses are risky and there can be no assurance
that any of our products or product candidates will achieve
commercial success or that competing therapies will not pre-empt
market opportunities that might exist for any of our products or
product candidates. (1)Data were extrapolated from Feldman HA,
Goldstein I, Hatzichristou DG, Krane RJ. Impotence and its Medical
and Psychosocial Correlates: Results of the Massachusetts Male
Aging Study, Journal of Urology. Vol. 151, 54-61, January 1994 and
World Population Projection Program Of United Nations (2002
Revision) with indirect standardization. (2)Shabsigh, R. (2002).
Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York:
Kensington. (3)Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp. Data accessed 11.20.03
(4)Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342:
1802-1813.
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