Lilly ICOS – a joint venture between ICOS Corp and Eli Lilly – has filed 2.5mg and 5mg once-a-day versions of the billion-dollar erectile dysfunction drug Cialis with European regulators.

The filing is based on data from three Phase III clinical trials which assessed Cialis’ safety and efficacy in a once-a-day regimen for the treatment of ED. Results found that the erectile function of men taking Cialis 5mg Once-A-Day was significantly improved compared to those taking placebo. A similar filing for Cialis (tadalafil) in the US and Canada is scheduled for later this year.

“We are very excited about the prospect of bringing Cialis Once-A-Day to the market in North America and Europe,” commented Paul Clark, ICOS Chairman and Chief Executive. “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,” he explained.

“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,” he added, as the company said in a statement that it expects to make a profit in 2007 of $0.53-$0.68 per share and targeted earnings of $1.23-$1.45 for 2008.

“Introducing the once-a-day treatment for ED is part of our long range strategic plan for maximizing the value of the tadalafil molecule,” said Leonard Blum, Senior Vice President of Sales and Marketing at ICOS. "The once-a-day dose would be priced less than the Cialis 10mg or 20mg tablet, commonly used on-demand and, as a result, could be a financially viable alternative to the current on-demand regimen.”