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 lcpharma for further
information about LifeCycle Pharma A/S.
LifeCycle Pharma A/S
lcpharma
View drug information on Fenofibrate.