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Nov 10, 2011
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Product Pipeline



Transplant Immunosuppression-LCP-Tacro™

LCP-Tacro™ is the lead Veloxis product candidate for immunosuppression in kidney and liver transplantation, and is currently in phase 3 clinical trials. Top-line results from a clinical phase 3 study in stable kidney transplant patients were announced in June 2011. In this non-inferiority study, LCP-Tacro™ dosed once a day successfully met all primary efficacy and safety end points when compared with the current leading transplant drug, Prograf® (Astellas Pharma US Inc), dosed twice a day.

Compared with Prograf® and Advagraf® (a once-daily dosage version of tacrolimus for organ transplants that was approved by the EMA in mid-2007), Veloxis believes that LCP-Tacro™ could have the following potential key differences:

  • Improved systemic absorption and reduced variability
  • Improved bioavailability, which thus requires a lower dose of tacrolimus
  • Limited peak-to-trough fluctuation
  • Once-daily dosing
Veloxis has chosen to prioritize its development efforts in pursuing LCP-Tacro™ for the treatment of kidney transplant patients because of the large potential patient population and demand.

Cardiovascular-FenoChol™, AtorFen™, and LCP-Feno™

Within the cardiovascular area, one product, FenoChol™, which is marketed as Fenoglide® and was developed using the proprietary Veloxis MeltDose® technology, has received approval from the FDA for commercial sale in the US for the treatment of dyslipidemia (which includes hypertriglyceridemia, mixed dyslipidemia, and hypercholesterolemia).

In addition, Veloxis has 2 product candidates: AtorFen™, a fixed-dose combination tablet of fenofibrate and atorvastatin, as well as LCP-Feno™, a generic 145-mg fenofibrate tablet. While these 2 phase 3 - ready product candidates are not in active development, Veloxis continues to pursue partnership opportunities.

Veloxis also has several nondisclosed product candidates in preclinical development in specialty therapeutic areas.

For more information on Veloxis clinical trials, go to http://www.clinicaltrials.gov/.