LifeCycle Pharma Announces Transplantation Programs on Track
The positive interim results for LCP-Tacro in stable liver transplant patients are based on a pre-planned assessment of 11 stable liver transplant patients and demonstrated that LCP-Tacro has a superior profile when compared to Prograf(R), namely higher bioavailability, better pharmacokinetics (PK) and once-a-day tablet administration. Prograf(R) is currently marketed worldwide by Astellas Pharma as twice-a-day capsules of tacrolimus. These results are consistent with the interim results reported from the Phase II clinical trial in stable kidney patients. In addition, the interim Phase II data further supports the series of successful Phase I trials of LCP-Tacro, involving more than 150 healthy volunteers, which demonstrated that LCP-Tacro has a once daily profile and higher bioavailability of tacrolimus.
LCP has also completed patient enrollment in its Phase II clinical trial for LCP-Tacro in stable kidney transplant patients. Top line results for the clinical phase II study LCP-Tacro in stable kidney transplant patients are expected in March 2008 and top line results for the clinical phase II study for LCP-Tacro in stable liver patients are expected in the second quarter of 2008 (2Q08).
LCP's Phase II clinical trial in stable liver transplant patients continues on track to enroll at least 39 additional patients, bringing the total number of targeted patients enrolled to 50, in up to 12 sites in the U.S. As with the kidney Phase II clinical trial, the Company expects that the liver Phase II clinical trial will confirm the proposed dosing regimen and provide a robust basis for the initiation of a Phase III clinical trial program in 2008 in de-novo liver and stable liver transplant recipients.
LCP-Tacro (Liver) Phase II Clinical Trial Design
The Phase II clinical trial, which commenced enrollment in December 2007, is 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(R) (tacrolimus) capsules Twice-A-Day. Stable liver transplant patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and kept on Prograf(R) for 7 days. Following a 24-hour PK assessment on Day 7 to determine pharmacokinetics for Prograf(R), all patients are converted to once daily LCP-Tacro for 7 days on a specific conversion scheme with no dose changes allowed until Day 14. On Day 14 and Day 21, a 24-hour LCP-Tacro PK assessment will be performed. On Day 22, except for patients converted back to their twice daily dose of Prograf, all patients are enrolling in the 52-week open-label extension study.
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 2006, worldwide sales of tacrolimus were approximately $1.4 billion, with some 50% of such sales generated in the United States, and 30% in Europe.
About LifeCycle Pharma A/S ("LCP")
LCP is an emerging specialty pharmaceuticals 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(R), LCP is able to develop drugs with enhanced absorption and thereby increased bioavailability. Currently, the Company has a diversified near- and medium-term pipeline, including a product ready for US commercialization, five product candidates in clinical trials and three in preclinical stages of development. LCP is listed on the OMX Nordic Exchange under the trading symbol (OMX: LCP). For further information, please visit www.lcpharma.com.
LifeCycle Pharma A/S
Flemming Ornskov, MD
President and CEO
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(917) 747-4938; FDM@lcpharma.com
Posted: January 2008