LCP-Tacro™ press room

Product Summary

• LCP-Tacro™ is the Veloxis lead product candidate for suppression of the immune response to prevent the rejection of transplanted organs (immunosuppression)
• Top-line results from clinical phase 3 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 3 study in patients who received just a kidney transplant (de novo) are expected by early 2013
• Veloxis expects to submit applications for registration in the EU and US respectively, in the first half of 2013
• LCP-Tacro™ could be the only once-daily drug in its class in the US when approved
• LCP-Tacro™ will be a branded primary immunosuppressant drug not automatically substitutable by generics
• In 2010, the immunosuppression market for transplant patients in the US, Japan, the UK, France, Germany, Italy, and Spain totaled approximately USD 5 billion