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Veloxis Pharmaceuticals A/S Announces Positive Results of 3002 Study on LCP-Tacro

Thursday, 27 Jun 2013 11:10am EDT 

Veloxis Pharmaceuticals A/S announced that LCP-TacroTM 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. Treatment failure rates through the first three months after transplant were 10.4% for LCP-TacroTM and 14.2% for Prograf. Similar incidence of adverse events and impact on laboratory results reported for LCP-TacroTM and Prograf. 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.