FDAnews
www.fdanews.com/articles/90575-lifecycle-s-combination-pill-comparable-to-lipitor-tricor

LIFECYCLE'S COMBINATION PILL COMPARABLE TO LIPITOR, TRICOR

February 27, 2007

LifeCycle Pharma has announced positive results from its Phase I clinical program with LCP-AtorFen, a fixed-dose combination product of atorvastatin and fenofibrate for the treatment of high cholesterol levels.

The program was a comparative pharmacokinetic study between LCP-AtorFen and Lipitor (atorvastatin) and Tricor (fenofibrate) and was carried out in Canada. LCP-AtorFen has a single-pill, once-daily dosing regime combining the active ingredients in Lipitor and Tricor.

The Phase I program showed LCP-AtorFen was safe and well tolerated and that the product had a similar rate and extent of absorption as Lipitor and Tricor. The company is now preparing for the initiation of a Phase II program, expected to start during the second quarter of 2007.

"This positive result confirms our confidence in the application of our MeltDose technology for producing convenient fixed-dose combination products of two different active ingredients within a single tablet," Flemming Ornskov, president and CEO of LifeCycle Pharma, said.