LifeCycle Pharma Announces Positive Data From LCP-AtorFen Phase I Clinical Program

Main Category: Cholesterol
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 27 Feb 2007 - 0:00 PDT

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LifeCycle Pharma A/S (OMX: LCP) announced today positive results from the company's 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(R) and Tricor(R) and was carried out in Canada. LCP-AtorFen has a convenient single pill once-daily dosing regime and is without food effect.

The Phase I program showed LCP-AtorFen was safe and well-tolerated and that the product had a similar rate and extent of absorption compared to Lipitor(R) and Tricor(R). The company is now preparing for the initiation of a Phase II program, expected to start during Q2 of 2007.

"We are pleased with the successful outcome of the Phase I program, and are on track to start our Phase II program with LCP-AtorFen as planned," said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "This positive result confirms our confidence in the application of our MeltDose(R) technology for producing convenient fixed-dose combination products of two different active ingredients within a single tablet," added Dr. Ornskov.

About LCP-AtorFen

LCP-AtorFen is our proprietary product candidate combining 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 high cholesterol levels, addressing three primary cardiovascular risk factors: low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides (TG). In the United States alone, sales of atorvastatin and fenofibrate were approximately euro 7.5 billion in 2005, an increase of 12% over 2004. The company's Phase I clinical program was initiated in October 2006.

About LifeCycle Pharma:

LifeCycle Pharma is an emerging pharmaceutical company with a broad and late stage product pipeline in therapeutic areas of cholesterol management, hypertension and organ transplant. LifeCycle Pharma's most advanced product has been filed with the U.S. FDA and is expected to enter the US market in the first quarter of 2008. LifeCycle Pharma's product candidates are proprietary and designed to improve the quality of existing drugs by enhancing the release and absorption of drugs in the human body. LifeCycle Pharma's proprietary technology platform, MeltDose(R) technology, offers lower dosing, reduced side effects and improved safety and patient compliance as well as reduced product development time and production costs. LifeCycle Pharma has formed several partnerships with major pharmaceutical companies and is clinically developing product candidates within a number of areas, including cholesterol management, hypertension and organ transplant. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). Please visit http://www.lcpharma.com for further information about LifeCycle Pharma A/S.

LifeCycle Pharma A/S
http://www.lcpharma.com

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