8/22/2013 9:40:49 AM
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To: NASDAQ OMX Copenhagen A/S -- LCP-Tacro™ has successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints. The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013.
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