LifeCycle Pharma Announces Positive Phase III Results: LCP-Tacro Trial in Stable Kidney Transplant Patients Meets All Primary Ef

LifeCycle Pharma Announces Positive Phase III Results: LCP-Tacro Trial in Stable Kidney Transplant Patients Meets All Primary Efficacy and Safety Endpoints

LCP-TacroTM dosed once a day successfully met the primary efficacy end point compared to Prograf® dosed twice a day

- LCP-TacroTM demonstrated a trend towards lower Rejection Rates as determined by Central Blinded Pathology reading

- Similar safety and tolerability profiles were demonstrated across both groups in the study

- The results were achieved with significantly lower doses of LCP-TacroTM compared to Prograf®

- Conference call to discuss the results will be hosted on June 21 at 3 p.m. CEDT (9 a.m. EDT)
HORSHOLM, Denmark, June 21, 2011 /PRNewswire/ -- LifeCycle Pharma A/S (OMX:LCP) today reported that the company's lead product candidate, LCP-TacroTM, successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III trial, Study 3001. The Phase III Open-label conversion (switch) study in 326 stable kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints.

"The results we have seen in this large Phase III study demonstrate that LCP-TacroTM allows for patients to be successfully converted from Prograf® to LCP-TacroTM at a lower dose and with once-daily convenient  dosing," said Dr. Suphamai Bunnapradist, M.D., Professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, California, U.S.A., "These data suggest that LCP-TacroTM may potentially offer an improvement in outcomes, as well as improved convenience for our transplant patients due to the once-a-day dosing."

LCP-TacroTM demonstrated very good efficacy and a trend toward lower rejection rates

The primary efficacy endpoint for the study was a comparison between once-daily sustained-release LCP-TacroTM and twice-daily immediate-release Prograf®. The composite primary endpoint comprised Biopsy-Proven Acute Rejection (BPAR, microscopic evidence of rejection), graft loss (return to dialysis or need for re-transplant), death and loss to follow-up. BPAR was assessed by both local and central pathologists blinded with regard to treatment assignment. In the primary analysis (local pathology for BPAR), the treatment failure rate at Month 12 for the composite endpoint was 2.5% (4 total treatment failures) for both LCP-TacroTM and Prograf®. The 95% confidence interval for the treatment difference was +/- 4.2%; well within the protocol pre-specified non-inferiority margin of +9.0%. In the secondary analyses (central blinded pathology for BPAR) the treatment failure rate during the study, including follow ups, for the composite endpoint was 2.5% for LCP-TacroTM and 4.9% for Prograf®. As measured by the central blinded pathologist, the rates of BPAR were 0.6% for LCP-TacroTM and 3.1% for Prograf® (p=0.214).

Safety profile positive and lower dose required

The primary safety analyses were the differences between LCP-TacroTM and Prograf® treatment groups at Month 12 (Day 360) with respect to the incidence of adverse events (AEs) and the incidence of predefined potentially clinically significant laboratory measures including: fasting plasma glucose; platelet count; white blood cell (WBC) count; aminotransaminases; total cholesterol; low density lipoprotein (LDL) cholesterol; triglycerides; and estimated glomerular filtration rate (eGFR). In all instances, there were no statistically significant differences between the two treatments.  More LCP-TacroTM patients discontinued the study than Prograf® patients. There was no consistent pattern to the types of events leading to discontinuation. 

In addition, the study results demonstrated that LCP-TacroTM patients, on average, required a daily dose that was 20% lower than patients receiving Prograf®, reflecting the improved absorption provided by LCP's proprietary MeltDose® formulation.

William Polvino, President & Chief Executive Officer of LifeCycle Pharma said, "We are very pleased with the results of this Phase III study which means that yet another important milestone has been reached on the way to obtaining marketing authorization for LCP-TacroTM. Further confirmatory testing is underway in LCP's second Phase III study in the de novo kidney transplant setting, Study 3002. Study results are expected from this second study by the end of 2012 with regulatory submissions planned in the US and EU in the first quarter of 2013."

Large market potential

There are estimated to be 165,000 patients in the US alone living with kidney transplants. Global sales of immunosuppressants for organ transplantation exceed $5bn., with Prograf the market leader with global sales in 2010 of $2bn. Currently no once-a-day primary immunosuppressant is approved in the US market. LCP holds the global rights for LCP-TacroTM.

Data presentation and conference call information

The full study results from this LCP-TacroTM switch study are planned for presentation at an upcoming scientific meeting.  Future announcement will be made regarding the specific scientific forum.  LCP will host a conference call at 3 p.m. CEDT (9 a.m. EDT) today, June 21, 2011, to comment on the results of this study.

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