Lilly ICOS plans to market once-a-day Cialis, Lilly diabetes drug shows promise

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Lilly ICOS is targeting men in their forties and fifties who use erectile dysfunction drugs on a “more frequently than average” basis with a once-a-day version of its Cialis (tadalfil) treatment. “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,” said ICOS CEO Paul Clark in a statement. Last week, Lilly ICOS submitted European regulatory filing for marketing approval of Cialis 2.5 mg and 5 mg once-a-day dosing and plans on filing for US and Canadian approval later this year. If approved, the US launch of once-a-day Cialis could happen by late 2007. “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,” with projected global sales of $250 million by 2010, Clark said. ICOS’ SVP of sales and marketing Leonard Blum added, “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.” Cialis competes in the $3 billion per year global ED drug market. Worldwide sales of Cialis reached $747 million in global sales last year, a 35% jump from 2004. Meanwhile, Eli Lilly this week reported promising study results for using Arxxant (ruboxistaurin mesylate), a first-of-its-kind oral therapy, in preventing diabetic retinopathy. In two phase III trials, the drug reduced the risk of sustained moderate vision loss by 41% when compared to placebo in patients with moderate to severe, nonproliferative diabetic retinopathy (DR). DR affects one-third of the world’s estimated 230 million diabetics, and analysts say Arxxant could generate more than $1 billion a year in sales for Lilly. The vision-threatening illness is currently treated with laser surgery. The drug works by limiting protein kinase C beta (PKC beta) overactivation and is the first of a new class of compounds being investigated for the treatment of DR. Lilly submitted an NDA for the DR indication in February, and the FDA accepted it for a priority review. The two Lilly studies—presented at the Annual ADA Scientific Sessions in Washington, DC—tracked 813 patients with the eye disease for three years. Over that time, 6.1%  who took Arxxant daily suffered moderate vision loss, compared to 10.2% of patients who took a placebo. The drug had no effect on glucose or blood pressure control, and fewer patients suffered serious adverse events while taking Arxxant than patients taking the sugar pill. Lilly is also exploring Arxxant for treating nerve pain associated with diabetes, but this area has proved ineffective in tests.

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