FDA grants LifeCycle Pharma SPA for LCP-Tacro pivotal Phase 3 study in 'de novo' kidney transplant patients

LifeCycle Pharma A/S (Copenhagen:LCP) today announced receipt of agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) of its pivotal Phase 3 study, Study 3002, for LCP-Tacro(TM) in patients, who have just received a kidney transplant ("de novo" transplant patients).

William Polvino, President & Chief Executive Officer of LifeCycle Pharma, said, "The SPA Agreement for Study 3002 of LCP-Tacro(TM) is a very significant achievement for LCP. We have now received a formal green light from the FDA as to our proposed clinical study design and are now well-positioned to move forward with the study start. Further, we have achieved increased clarity on the costs and timing to regulatory approval.  LCP re-affirms its expectations of a target NDA filing in the first quarter of 2013, and we anticipate study initiation in the third quarter of this year."

"The optimized and patent-protected formulation used in LCP-Tacro(TM) provides desirable once-daily dosing of tacrolimus and is intended to reduce the peak-to-trough variability in blood levels," added Dr. John Weinberg, Senior Vice President, Commercial Development and Strategic Planning.  He continued, "We are optimistic that LCP-Tacro(TM) will provide important patient benefits compared to existing treatments, will be a valuable addition to the therapeutic regimens available to transplant physicians, and has significant market potential."

The LCP Study 3002 is a randomized, double-blind, multicenter study that will compare once-daily LCP-Tacro(TM) against the current market leading comparator, twice-daily Prograf(R) in de novo kidney transplant patients.  A 12-month treatment period will be followed by a 12-month blinded extension. The primary endpoint of the study will be to demonstrate the non-inferiority of LCP-Tacro(TM), compared to Prograf(R), on kidney graft function (biopsy proven acute rejection, graft failure, death, or loss to follow up) at 12 months.  Secondary endpoints will include safety, tolerability and renal function assessments. The study will be conducted at approximately 75-100 transplant centers, primarily in the United States and Europe.

LCP has developed LCP-Tacro(TM) as an optimized version of the highly successful transplant drug, tacrolimus (branded Prograf(R)).  Worldwide sales of Prograf(R) were about 2 billion USD in 2009 (IMS; all rights reserved).