LifeCycle Pharma Announces Positive Results From Head-to-Head Clinical Trial of LCP-Tacro Versus Advagraf For the Prevention of Organ Rejection After Transplantation
Data Shows LCP-Tacro Has Superior Profile When Compared to Advagraf, Currently Marketed in a few European Countries by Astellas Pharma as a Once-A-Day Formulation of Tacrolimus
Summary: LifeCycle Pharma Announces Positive Results From Head-to-Head Clinical Trial of LCP-Tacro Versus Advagraf For the Prevention of Organ Rejection After Transplantation. The Data Shows LCP-Tacro Has Superior Profile When Compared to Advagraf, Currently Marketed in a few European Countries by Astellas Pharma as a Once-A-Day Formulation of Tacrolimus
HØRSHOLM, Denmark, November 7, 2007; LifeCycle Pharma A/S (OMX: LCP) (the "Company" or "LCP"), an emerging specialty pharmaceutical company, today announced results from a Phase I head-to-head clinical trial comparing LCP-Tacro, the Company's lead product candidate being developed as a once-daily tablet version of tacrolimus, to Advagraf, currently marketed in a few European countries as a once-daily capsule version of tacrolimus. The results confirm that with LCP-Tacro, the Company is developing an improved version of tacrolimus when compared to both Advagraf and Prograf®, the latter being the world's leading drug for immunosuppression following organ transplantation.
"The results of this head-to-head clinical trial represent yet another breakthrough for LCP as we continue to demonstrate LCP-Tacro's superiority to both Prograf and Advagraf," said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "The data from this Phase I clinical trial is consistent with the Phase I clinical trial data we witnessed for LCP-Tacro when compared to Prograf, now in Phase II for the prevention of organ rejection after kidney transplantation. We have every reason to believe that the clinical data that supports LCP-Tacro's superior profile when compared to Prograf is reproducible and we will also demonstrate a superior profile to Advagraf," added Dr. Ornskov.
The Phase I head-to-head clinical trial, designed as a multi- dose trial, enrolled 19 healthy volunteers. Clinical data confirmed that LCP-Tacro, when compared to Advagraf, demonstrated:
* Approximately 50% higher bioavailability
* Flatter product profile, (i.e. a lower Cmax/Cmin, or peak-to-trough, ratio)
o In other words, the difference in blood plasma concentration when measured at the highest and the lowest points is less when compared to Advagraf
* Potential for administration at lower daily doses
"The results from LCP's head-to-head trial are excellent and promising for transplant patients and physicians world-wide," commented Dr. Sundaram Hariharan of the Medical College of Wisconsin, Milwaukee WI, USA. "The clinical data reported by LCP to date support the Company's objective of developing an improved version of tacrolimus. LCP-Tacro's once-a-day profile will provide ease of administration leading to greater patient compliance and its better bioavailability could ultimately lead to lower daily dosing. All these challenges exist with current approved medications for solid organ transplantation."
The results of this study come less than two weeks after LCP announced positive interim Phase II clinical trials results for LCP-Tacro in stable kidney transplant patients, which confirmed a superior profile of a once-a-day tablet formulation and higher bioavailability when compared to Prograf, also currently marketed worldwide by Astellas Pharma as a twice-a-day capsule formulation.
While the Company's current regulatory filings do not contain additional protocols to compare LCP-Tacro to Advagraf, the Company may conduct subsequent studies once LCP-Tacro enters Phase III clinical trials and pending Advagraf's broader geographic availability.
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 when compared to both 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 profile and is expected to provide significant improvements for the patients.
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 the 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 7 major markets (US, Japan, France, Germany, Italy, Spain and UK) is approximately $3.3B and is estimated to grow by approximately 5-10% per year.
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®, 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, four product candidates in clinical trials and four 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.
President and CEO
+45 (24) 20 03 68; (917) 288-6446
Michael Wolff Jensen
EVP and CFO
+45 4074-6244; MWJ@lcpharma.com
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(917) 747-4938; FDM@lcpharma.com
Posted: November 2007