LifeCycle Pharma announces positive data from LCP-AtorFen Phase II clinical program

Company Announcement no. 22/2008

To: OMX Nordic Exchange Copenhagen		        Hørsholm, Denmark, May 7, 2008


LifeCycle Pharma announces positive data from LCP-AtorFen Phase II clinical
program 

Summary: LifeCycle Pharma successfully completes Phase II LCP-AtorFen clinical
program and expects to initiate Phase III clinical program in 2H 2008 while
simultaneously seeking a partner for completion of the Phase III clinical trial
program and subsequent commercialization. 
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
Executive Vice President and CFO
+45 2030 6985
HCT@lcpharma.com