LCP-Tacro™


Product summary

  • LCP-Tacro™ is Veloxis' lead product candidate for suppression of the immune response to prevent the rejection of transplanted organs (immunosuppression)
  • Top-line results from clinical phase III study in stable kidney transplant patients were announced June 2011
    • LCP-Tacro™ dosed once a day successfully met the primary efficacy end point compared with the current leading transplant drug, Prograf®, dosed twice a day
    • LCP-Tacro™ demonstrated a trend toward lower rejection rates (p=0.214)
    • LCP-Tacro™ and Prograf® demonstrated similar safety and tolerability profiles
    • The results were achieved with significantly lower doses of LCP-Tacro™ compared with Prograf®
  • Top-line results from a clinical phase III study in newly kidney transplanted patients (de novo) are expected mid-2013
  • In April 2013, Veloxis submitted a marketing authorization Application (MAA) 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
  • Veloxis expects to file registration in the U.S. in the second half of 2013
  • LCP-Tacro™ will be a branded primary immunosuppressant drug not automatically substitutable by generics
  • In 2010, more than 50,000 organ transplants were conducted in the United States, Japan, the United Kingdom, France, Germany, Italy and Spain