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Statement to the Media: Lilly ICOS Pleased with European Patent
Office's Decision to Affirm Revocation of Pfizer's Patent on Treatment of
Erectile Dysfunction
BOTHELL, Wash. and INDIANAPOLIS, Ind., Feb. 10 /PRNewswire-FirstCall/ -- Lilly
ICOS LLC (NYSE:LLYNYSE:andNYSE:NASDAQ:NYSE:ICOS), marketer of Cialis(R)
(tadalafil), a PDE5 inhibitor indicated for the treatment of erectile
dysfunction (ED), is pleased with the European Patent Office's (EPO) final
decision to affirm its earlier decision to revoke Pfizer's method-of-use patent
- European Patent EP-B-0702555, containing claims for the use of any PDE
inhibitor for the manufacture of an oral treatment for ED. The ruling was made
following a three-day hearing by a Board of Appeal of the EPO, which concluded
on Thursday, February 3, 2005. Lilly ICOS offered the following statement
regarding the decision:
-- This decision by the Board of Appeal confirmed our view that the patent was
invalid.
-- The decision makes it clear that Pfizer is not entitled to exclusivity in
the area of oral PDE5 inhibitors for erectile dysfunction (ED) in many of the
countries in Europe.
-- The decision affirms the EPO's previous decision to revoke this patent in
2001, and is consistent with a final UK decision to revoke Pfizer's
corresponding patent in 2002.
-- Cialis is available in Europe to help millions of men who suffer from ED.
Cialis is the only oral ED treatment shown to improve erectile function up to
36 hours in most men.
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 approximately 100 countries, including Australia,
Brazil, Mexico, Canada, the United States and countries throughout Europe. More
than 3.5 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
or 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 does not protect a man or his partner
from sexually transmitted diseases, including HIV.
Individual results may vary. Cialis studies were not designed to assess
multiple intercourse attempts after a single dose. For full patient
information, visit http://www.cialis.com/.
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS Corporation (NASDAQ:ICOS) and Eli
Lilly and Company (NYSE:LLY), developed tadalafil for the treatment of erectile
dysfunction.
ICOS Corporation, a biotechnology company headquartered in Bothell, Washington,
is dedicated to bringing innovative therapeutics to patients. ICOS is marketing
its product, Cialis (tadalafil), through Lilly ICOS LLC. ICOS is working to
develop treatments for serious unmet medical conditions such as chronic
obstructive pulmonary disease, benign prostatic hyperplasia, cancer and
inflammatory diseases.
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. P-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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO
DATASOURCE: Lilly ICOS LLC
CONTACT: Lacy Fitzpatrick of ICOS, +1-425-415-2207; or
Kindra Strupp of Lilly US, +1-317-277-5170