LifeCycle Pharma Announces Positive Data from LCP-AtorFen Phase II Clinical Program
LifeCycle Pharma A/S (OMX:LCP) announced today positive results from the company’s Phase II clinical program with LCP-AtorFen, a fixed-dose combination product of atorvastatin and fenofibrate for the treatment of mixed dyslipidemia. LCP-AtorFen is a convenient single tablet with a once-daily dosage profile and is without food effect.
“The Phase II clinical program confirmed that LCP-AtorFen was safe and well-tolerated. In addition, the study showed significantly better effect of our LCP-AtorFen combination therapy for HDL-C and Triglycerides versus atorvastatin (Lipitor) monotherapy, and for non-HDL, LDL-C, Triglycerides and Total Cholesterol versus fenofibrate monotherapy”, said Dr. Michael Beckert, Executive Vice President and Chief Medical Officer of LifeCycle Pharma.
LifeCycle Pharma is preparing for end of Phase II discussions with the FDA for the initiation of a Phase III clinical program which is expected to start during the second half of 2008. LifeCycle Pharma intends to develop a partnership with an established pharmaceutical company to provide funding for the Phase III clinical studies, which will be conducted in approximately 1,000 dyslipidemia patients.
“These results are very exciting and confirm the principle of using a statin/fenofibrate combination. LCP-AtorFen opens the opportunity to address all angles of the atherogenic triad (LDL-C, HDL-C and triglycerides) in one single tablet,” said Dr. Michael Davidson, Clinical Professor at University of Chicago Pritzker School of Medicine and Executive Medical Director of Radiant Research and one of the clinical investigators of this study.
The trial was designed as a double-blinded, randomized and actively controlled study to compare LCP-AtorFen with Lipitor® and Tricor® in approximately 220 patients with mixed dyslipidemia over 12 weeks, followed by a 52-week open-label extension study initiated in the fourth quarter of 2007.
“We are pleased with the successful outcome of the Phase II clinical program, and are on track to start our Phase III program with LCP-AtorFen as planned,” said Dr. Flemming Ørnskov, President and CEO of LifeCycle Pharma. “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,” added Dr. Ørnskov.
About LCP-AtorFen
LCP-AtorFen is the company’s proprietary product candidate combining a standard dose atorvastatin (the active ingredient of Lipitor) and the lowest dose of fenofibrate without food effect. LCP-AtorFen is designed to be a powerful and safe treatment of mixed dyslipidemia, addressing three primary cardiovascular risk factors: low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides (TG). In North America alone, sales of atorvastatin and fenofibrate were approximately USD 10.8 billion in 2006 (IMS Health; All rights reserved). The company’s Phase II clinical program was initiated in July 2007.
About LifeCycle Pharma A/S (“LCP”)
LCP is an emerging specialty pharmaceutical company that, through innovative technologies, is able to rapidly develop a portfolio of differentiated products to meet the unique needs of key therapeutic markets and patient populations. This includes products for immunosuppression, specifically organ transplantation, and to combat certain cardiovascular diseases. By using its unique and patented delivery technology, MeltDose®, LCP is able to develop drugs with enhanced absorption and thereby increased bioavailability. LCP has a cholesterol lowering product, FenoglideTM, currently on the U.S. market and a diversified near- and medium-term pipeline, including five product candidates in clinical trials and three in preclinical stages of development. LCP is listed on the OMX Nordic Exchange Copenhagen under the trading symbol (OMX: LCP). For further information, please visit www.lcpharma.com.
Contact:
LifeCycle Pharma A/S Hans Christian Teisen, +45 2030 6985 Executive Vice President and CFO HCT@lcpharma.com
Source: LifeCycle Pharma A/S