Current Investment Highlights


  • Enrolment completed in the pivotal LCP-Tacro™ Phase III study in de novo kidney transplant patients. Results from this study are expected mid-2013
  • Positive results of LCP-Tacro Phase III "Switch" Study
  • Exclusive distribution agreement with Chiesi Farmaceutici S.p.A for the commercialization and distribution of LCP-Tacro™ in certain countries, including Europe, Turkey and CIS countries
  • Submission of marketing authorization Application (MAA) in April 2013 to the European Medicines Agency (EMA) seeking approval to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union
  • Financing in place to support development, differentiation and commercialization activities through initial launch of LCP-Tacro
  • Full organizational focus on the completion of the development and subsequent commercialization of LCP-Tacro™
  • Preliminary analysis of the STRATO Phase lllb study suggests reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro™

Expected 2013 Milestones

  • Veloxis anticipates releasing final results from its STRATO tremor study in May 2013
  • The pivotal study results from the 3002 kidney transplant study are on target for release in mid-2013 with expected NDA filing with the FDA in the second half of 2013. If successful, and if approved by EMA and FDA, commercialization of LCP-Tacro could begin by approximately the fourth quarter 2014


Veloxis Pharmaceuticals A/S (OMX : VELO) 15:57 on Jun 18, 2013
Last Price Change Open Day High 52-Week High
0.60
0.01 down  (1.64%) 0.60 0.62 0.72
Volume Previous Close Day Low 52-Week Low
288,418 0.61 0.59 0.32