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LifeCycle Pharma Announces Positive Results from a 12 Month Extension Phase of the Phase 2 Clinical Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients

HØRSHOLM, Denmark--(BUSINESS WIRE)--Sep 29, 2009 - LifeCycle Pharma A/S (CSE:LCP) today announced positive results from a completed 12 month extension phase of the Phase 2 clinical study of LCP-Tacro tablets in stable liver transplant patients. LCP-Tacro is a once daily immunosuppression drug to prevent rejection after organ transplantation. These new data demonstrated that LCP-Tacro tablets for stable liver patients continues in the extension phase of the study to have a potential best-in-class profile when compared to the currently marketed twice daily tacrolimus capsule, Prograf®, by maintaining




  • the once daily administration,

  • Improved bioavailability by approximately 30%, leading to a 70% dosing compared to Prograf® in the initial part of the study

  • Reduced variability (peak-to-trough ratio) with a 30% reduced peak


According to LCP, the positive data from the 12 month extension phase of the Phase 2 study in stable liver transplant patients provide a confirmation of the proposed dosing regimen. With the results announced today as well as the results announced in August 2009 from the clinical Phase 2b pharmacokinetic studies, LCP can now initiate discussions with the FDA regarding the design and the timing of the phase 3 program for liver transplant patients.


LCP?Tacro (Liver) Phase 2 Clinical Study Design


The initial Phase 2 clinical study, which commenced enrollment in December 2007, enrolled a total of 57 patients in multiple sites in the U.S. and 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 were 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. In total 49 continued in the 12 month extension phase of the study in a LCP-Tacro arm only.


About LCP-Tacro™ and tacrolimus


Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro™ is being developed as a once daily tablet version of tacrolimus, with improved bioavailability and reduced peak-to-trough variability when compared to Astellas Pharma's Prograf®, a twice daily version of tacrolimus, marketed worldwide, and its once daily version of tacrolimus, Advagraf®, marketed in some European countries.


Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity and opportunistic infections. 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.


About Solid Organ Transplant Rejection


The prophylactic treatment of transplant allograft rejection is a major significant segment of the worldwide immunosuppressive market for which sales of Prograf® in 2008 were approximately USD 1.9 billion (IMS; all rights reserved).


About LifeCycle Pharma A/S (LCP)


Based in Hørsholm, Denmark, with an office in New York, LCP is an emerging specialty pharmaceutical company. Clinical development is the core of LCP's effort to develop a product portfolio which includes products for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. As a fully integrated company, LCP adapts new technologies on a fast commercial timetable. LCP's unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability – at low-scale up costs – not only for a broad spectrum of drugs already on the market but also for new chemical entities. LCP has a cholesterol-lowering product, Fenoglide® currently on the U.S. market and a diversified near- and medium-term pipeline with four product candidates in clinical trials and a number of projects in preclinical development. LCP is listed on the NASDAQ OMX Copenhagen under the trading symbol (OMX: LCP).

Posted: October 2009