Icos (NASDAQ:ICOS)
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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.