CORRECTION: LifeCycle Pharma Announces Positive Topline Results from Phase II Clinical Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients


Company Announcement no. 26/2008

To: OMX Nordic Exchange Copenhagen		        Hørsholm, Denmark, July 8, 2008


LifeCycle Pharma Announces Positive Topline Results from Phase II Clinical
Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients 

New data confirm potential best-in-class profile of LCP's once daily tablet
formulation with higher bioavailability when compared to twice daily Prograf®
which is currently marketed worldwide by Astellas Pharma. 

LifeCycle Pharma A/S (OMX:LCP) today announced positive top-line results from a
completed Phase II clinical study of LCP-Tacro tablets in stable liver
transplant patients which are in line with earlier data announced for stable
kidney transplant patients.  These new data for LCP-Tacro, a once daily
immunosuppression drug to prevent rejection after organ transplantation,
demonstrated that LCP-Tacro tablets also for stable liver patients have a
potential best-in-class profile when compared to the currently marketed twice
daily tacrolimus capsule, Prograf®, by indicating: 
•	Once daily administration
•	Improved bioavailability by approximately 30%, leading to a 70% dosing
compared to Prograf® 
•	Reduced variability (peak-to-trough ratio) with a 30% reduced peak

On Wednesday July 9, 2008, the results will be presented at the 2008 Joint
International Congress of ILTS, ELITA & LICAGE in Paris. 

According to LCP, the positive Phase II clinical data in stable kidney and
liver transplant patients provide a very robust, statistical confirmation of
the proposed dosing regimen.  With the results from the clinical phase ll
program, LCP expects to initiate the Phase III clinical trial program in stable
transplant patients by late 2008. In addition, these data are a solid basis to
conduct Phase IIb pharmacokinetic studies in de-novo kidney and liver
transplant patients, subsequently leading to Phase III de-novo studies in the
first half of 2009. 

“We are very excited about these data”, said Dr. Michael Beckert, Executive
Vice President and Chief Medical Officer of LCP. “The consistency of the
results across different patient populations in Phase II, both in  kidney and
liver transplant patients, as well as compared to our Phase I data in more than
180 healthy volunteers, is very impressive and confirms LCP-Tacro's
best-in-class profile”, Dr. Michael Beckert added. “This is one more milestone,
we have achieved on our way towards a fully integrated speciality
pharmaceutical company in the area of transplantation care and immunology”. 

LCP‐Tacro (Liver) Phase II Clinical Study Design
The Phase II clinical study, which commenced enrollment in December 2007, was a
three sequence, open-label, multi‐center, prospective, conversion study in
stable liver transplant patients to assess and compare the pharmacokinetics
(Cmax, C24, and AUC), and safety of LCP‐Tacro (tacrolimus) tablets Once‐A‐Day
versus Prograf® (tacrolimus) capsules Twice‐A‐Day. Stable liver transplant
patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and
kept on Prograf® for 7 days, followed by a 14-day treatment period with
LCP-Tacro tablets. Pharmacokinetic assessment was performed on Day 7 (Prograf®)
and Day 14 & 21 (LCP-Tacro). On Day 22, patients were offered to enroll in the
52‐week open‐label extension study. The phase II clinical study enrolled 57
evaluable patients in 15 sites in the U.S. 

About LCP‐Tacro & Tacrolimus
Tacrolimus is a leading immunosuppressive medication to prevent rejection after
organ transplantation. LCP‐Tacro is being developed as a once‐daily tablet
version of tacrolimus, with improved bioavailability and reduced variability in
absorption when compared to Astellas' twice daily version of tacrolimus
(Prograf® worldwide) and its prolonged‐release version of tacrolimus (Advagraf
in Europe). Clinical trials have demonstrated that LCP‐Tacro has a superior
bioavailability and PK profile and is expected to provide significant
improvements for patients currently on Prograf®. Transplant patients need to
maintain a minimum level of tacrolimus in the blood to prevent organ rejection,
but too high levels increase the risk of serious side effects such as kidney
damage or hypertension. Therefore, tacrolimus levels need to be managed
carefully and transplant patients typically are obliged to make frequent visits
to the hospital for monitoring and dose adjustments for months after receiving
a new organ. Management of tacrolimus levels is complicated by the low
bioavailability of Prograf®, its variable absorption and interaction with food
and other drugs. The current market size for immunosuppressants used in
transplantation in the seven major markets (US, Japan, France, Germany, Italy,
Spain and UK) is approximately $3.3B and growing by approximately 5‐10% per
year. In 2007, worldwide sales of tacrolimus were approximately $1.64 billion,
with some 50% of such sales generated in the United States, and 30% in Europe. 

Contact:
LifeCycle Pharma A/S
Hans Christian Teisen
Executive Vice President and CFO
+45 7033 3300
HCT@lcpharma.com

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 US market and a
diversified near- and medium-term pipeline, including four product candidates
in clinical trials and two 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.