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, Washington and Indianapolis, Indiana (ots/PRNewswire)
Lilly ICOS LLC (NYSE: LLY and Nasdaq: 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.
About Cialis
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.
The most commonly reported adverse events with Cialis are headache, upset stomach, nasal congestion, backache, muscle ache, dizziness and flushing. The adverse events reported with Cialis were transient and generally mild or moderate. As with other PDE5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates or for those who have cardiac disease and for whom sexual activity is not advisable.
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, 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.
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.
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Contact:
Lacy Fitzpatrick of ICOS, +1-425-415-2207; or Jane Calloway of Lilly,
+1-317-651-5870. Photo:
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