Danish biotech company LifeCycle Pharma has commenced Phase II clinical studies of its drug candidate LCP-Atorfen for the treatment of high cholesterol levels. The fixed-dose drug combines atorvastatin, the active ingredient of Pfizer's hugely successful anti-cholesterol drug Lipitor, and fenofibrate. The idea of the combination drug is to address all angles of the so-called atherogenic triad* in a single once daily pill.
Michael Wolff Jensen, LifeCycle Pharma's finance director, comments: "This is an extremely important product for us, and the commencement of Phase II studies is yet another milestone for use. We are holding to our previously announced time plan that we will begin the studies in mid-2007."
If all goes according to plan, the clinical data will be available in 2008 after which Phase III clinical studies can begin. The final product could reach the market by 2011, which is when the patent expires on Pfizer's Lipitor. Worldwide, Lipitor sales in 2006 totalled USD 13.6 bn, up 6% on the 2005 figure. Worldwide sales of fenofibrate in 2006 were USD 1.7 bn, up 16% on 2005.
The news was reported by national daily newspaper Børsen and in a press release from LifeCycle Pharma.
LifeCycle Pharma is based in Hørsholm north of Copenhagen. The company utilizes its proprietary Meltdose technology to improve the bioavailability of known and established compounds so that patients can absorb them more effectively. LifeCycle Pharma is listed on the OMX Nordic Exchange.
*a trio of biochemical entities linked to the formation of furred-up arteries: cholesterol associated with low density lipoprotein (LDL), cholesterol associated with high density lipoprotein (HDL), and triglycerides – Ed.