Announcement no. 16/2007
To OMX Nordic Exchange Copenhagen A/S Hørsholm, Denmark, July 12 2007
LifeCycle Pharma to Initiate Phase II Clinical Trial of LCP-AtorFen for the
Treatment of High Cholesterol Levels
Summary: LifeCycle Pharma will initiate a U.S. Phase II clinical trial of
LCP-AtorFen, a fixed-dose combination of atorvastatin and fenofibrate, for the
treatment of high cholesterol levels
Hørsholm, Denmark, July 12 2007; LifeCycle Pharma A/S (OMX:LCP) today announced
it will initiate a Phase II clinical trial program using LCP-AtorFen, a
fixed-dose combination of atorvastatin and fenofibrate, for the treatment of
high cholesterol levels. LCP-AtorFen will be a powerful and safe treatment of
high cholesterol levels, addressing three primary cardiovascular risk factors:
low density lipoprotein cholesterol (LDL-C), high density lipoprotein
cholesterol (HDL-C) and triglycerides (TG).
The trial is designed as a double-blind, randomized, active controlled study to
compare LCP-AtorFen with Lipitor® and Tricor® in around 200 patients with Mixed
Dyslipidemia over 12 weeks followed by an open-label extension study for one
year. “This trial is supposed to give us substantial guidance for planning a
Phase III program in different patient populations”, said Dr. Michael Beckert,
Chief Medical Officer at LifeCycle Pharma.
“We are extremely pleased to have met another of our milestones with the start
of this trial”, said Dr. Flemming Ørnskov, CEO of LifeCycle Pharma. “Our
LCP-AtorFen program is progressing as planned and we look forward to seeing data
from the Phase II trial next year.”
“This is the start of an exciting clinical development program. LCP-AtorFen, the
combination of one of the most potent and safe statins (atorvastatin) plus a
safe and efficacious fibrate (fenofibrate), opens the opportunity to address all
angles of the atherogenic triad (LDL-C, HDL-C and Triglycerides) in one single
pill”, said Dr. Michael Davidson, Clinical Professor at University of Chicago
Pritzker School of Medicine, Executive Medical Director of Radiant Research and
one of the clinical investigators for this study.
About high cholesterol levels:
According to the American Hearth Association (AHA), over 105 million American
adults have total blood cholesterol values of 200 mg/dL and higher, and 36.6
million American adults have levels of 240 or above. In adults, total
cholesterol levels of 240 mg/dL or higher are considered high, and levels from
200 to 239 mg/dL are considered borderline-high. Statins are typically
recommended as first line therapy, but they have limited impact on HDL-C and
triglycerides (TG), and therefore they are often used in combination with other
drugs, including fenofibrate.
There are many different statins, but the market leader is Lipitor®
(atorvastatin), which is marketed by Pfizer. Worldwide atorvastatin sold for
$13.6 billion in 2006, a 6% growth over 2005 (source: IMS). Thus, Lipitor® is
the world's leading pharmaceutical product. Sales of fenofibrate have increased
significantly in the last few years, and in 2006 fenofibrate sold for $1.7
billion worldwide, an increase of 16% over 2005 (source: IMS).
About LCP-AtorFen:
LCP-AtorFen is LifeCycle Pharma's 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 cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)
and triglycerides (TG).
LCP-AtorFen is being developed as a single tablet to be taken once daily when
convenient for the patient.
For further information please contact:
LifeCycle Pharma A/S
Michael Wolff Jensen
Executive Vice President and CFO
Tel. +45 40 74 62 44
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About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in Hørsholm, Denmark, is an emerging
pharmaceutical company with a broad and late stage product pipeline in
therapeutic areas of cholesterol management, hypertension, organ transplant and
autoimmune diseases. LifeCycle Pharma's proprietary technology platform,
MeltDose® technology, offers lower dosing, reduced side effects and improved
safety and patient compliance, as well as reduced product development time and
development costs. LifeCycle Pharma is listed on the OMX Nordic Exchange under
the trading symbol (LCP). Please visit www.lcpharma.com for further information
about LifeCycle Pharma A/S.
LifeCycle Pharma to Initiate Phase II Clinical Trial of LCP-AtorFen for the Treatment of High Cholesterol Levels
| Source: Veloxis Pharmaceuticals A/S
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