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LifeCycle Pharma Announces Positive Top-Line Results Of Phase II Clinical Trial Of LCP-Tacro In Stab

Health and Medical News - Transplants & Organ Donations
Tuesday, 04 March 2008
LifeCycle Pharma A/S (OMX: LCP), announced positive to top-line results from a completed Phase II clinical trial for LCP-Tacro in stable kidney transplant patients. Data demonstrated that LCP-Tacro, a once daily immunosuppression drug for the treatment of kidney transplant patients, has a potential best-in-class profile when compared to the presently marketed twice daily tacrolimus capsule, Prograf, by indicating: - Higher bioavailability by more than 40 per cent - Improved pharmacokinetics - Reduced variability (peak-to-trough ratio) In 2007, worldwide sales of Prograf were approximately USD 1.6 billion (IMS), which shows that the immunosuppression market is a major therapeutic area with established commercial potential. "The results are a very valuable milestone for LCP and demonstrate LCP-Tacro's potential advantages over Prograf ," said Dr. Flemming Ã?rnskov, President and CEO of LCP. "It is a essential step forward for our transplantation franchise and towards our strategy of becoming a entirely integrated specialty pharmaceutical company. With these positive data we expect to initiate phase III clinical studies in the second half of 2008. LCP-Tacro will be the first product that we expect to entirely develop and commercialize ourselves in chosen markets," said Dr. Ã?rnskov. "We believe the results from this Phase II study are promising for transplant patients and physicians worldwide," said Dr. Michael Beckert, EVP and Chief Medical Officer of LCP. "The data support LCP's objective of developing an enhanced version of tacrolimus, which represented approximately 1/3 of total U.S. sales of immunosuppression drugs for transplantation in 2007. LCP-Tacro's enhanced pharmacokinetics may make this a safer product than Prograf. We believe LCP-Tacro's once daily profile will provide increased easiness of administration, which could potentially lead to greater patient compliance, and its higher bioavailability could ultimately lead to lower daily dosing, as compared with presently permitted medications for solid organ transplantation as compared to Prograf," said Dr. Beckert. LCP believes that the positive Phase II clinical data provide a robust, statistical affirmation of the proposed dosing regimen, supporting the initiation of a Phase III clinical trial program in the second half of 2008 in both de-novo and stable kidney transplant patients. About the LCP-Tacro (Kidney) Phase II Clinical Trial Design The Phase II clinical trial, which commenced enrollment in July 2007, was a 3 sequence, open-label, multi-center, prospective, conversion study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets once daily dosage versus Prograf (tacrolimus) capsules twice daily dosage. Stable kidney transplant patients who fulfilled all inclusion/exclusion criteria were enrolled and kept on Prograf for 7 days. Following a 24-hour pharmacokinetics study on Day 7 to determine pharmacokinetics of Prograf, all patients were converted to once daily LCP-Tacro. On day 14 and day 21, a 24-hour LCP-Tacro pharmacokinetics study was performed. On day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days which ends with a safety assessment on day 52. About LCP-Tacro & tacrolimus Tacrolimus is a leading immunosuppression drug used to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once daily tablet version of tacrolimus, with enhanced bioavailability and decreased variability in absorption when compared to Astellas Pharma's twice daily version of tacrolimus, Prograf, marketed worldwide, and its once daily version of tacrolimus, Advagraf®, presently marketed in some European countries. Clinical trials have demonstrated that LCP-Tacro has a higher bioavailability and enhanced pharmacokinetics when compared to Prograf, and LCP believes LCP-Tacro will provide essential improvements for patients presently taking or those who may in future be prescribed Prograf or Advagraf. Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but excessive levels increase the risk of serious side effects like kidney damage. Therefore, tacrolimus levels need to be managed carefully and transplant patients usually are obliged to make frequent visits to the hospital for monitoring and dose adjustments for months after receiving a new organ. LCP believes management of tacrolimus levels is complicated by the relatively low bioavailability of Prograf, its variable absorption and its interaction with food and other drugs. About LifeCycle Pharma A/S (LCP) LCP is an emerging specialty pharmaceutical company that, through innovative technologies, is able to fast develop a portfolio of differentiated products to meet the unique requires 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 improved absorption and thus increased bioavailability. LCP has a cholesterol lowering product, Fenoglide, presently on the U.S. market and a diversified near- and medium-term pipeline, including five product candidates in clinical trials and 3 in preclinical stages of development. LCP is listed on the OMX Nordic Exchange Copenhagen under the trading symbol (OMX: LCP). LifeCycle Pharma

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