Envarsus® XR Demonstrates Lower Treatment Failure Rate in African–Americans Compared to Twice–Daily Tacrolimus (Prograf®)

– Result seen across stable and de novo kidney transplant patients –
– Data to be presented at the World Transplant Congress –

Hørsholm, Denmark (June 30, 2014) –Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled “Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules”. The presentation will occur at 6:30 pm – 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.

Key points:

  • Problem: Managing immunosuppression of African-American kidney transplant recipients can be challenging, as are clinical outcomes for this demographic group
  • Envarsus XR is an extended release formulation of tacrolimus being designed for once-daily dosing, flatter pharmacokinetics and greater bioavailability compared to twice-daily Prograf (tacrolimus). Data from two Phase III trials were pooled (Envarsus XR n=428; Prograf n=433) and several pre-specified subgroup analyses were conducted
  • African-American subgroup demonstrated significantly less efficacy failure in favor of Envarsus XR (-13.82%, CI=-27.22%, -0.31%)
  • A second subgroup, older patients greater than 65 years of age demonstrated a similar significant result. Other pre-specified subgroups trended toward improved efficacy with Envarsus XR
  • Other presentations on Envarsus XR accepted for presentation:
    • Abst.2160, 11:39 AM/ Wednesday, July 30th, 2014/Room 2005/2007.
      Once-daily Envarsus Demonstrates Comparable Efficacy and Safety to Twice-Daily Prograf: A Phase 3 Study for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
      L. Rostaing, K. Ciechanowski, S. Bunnapradist, H.T. Silva, J.M. Grinyo, K. Budde
    • Abst. A208, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
      Once-Daily MeltDose Tacrolimus (Envarsus) Offers Dosing Flexibility and Maintains Therapeutic Activity When Make-Up Dose is Taken Outside of Schedule
      S. Gabardi, R. Nachtrieb, V. Nigro
    • Abst.A212, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
      Higher Initial Exposure of Envarsus Immediately Post Transplantation is Not Associated with Increased Risk of Delayed Graft Function in Kidney Transplant Patients Treated with Novel Once-daily MeltDose Tacrolimus (Envarsus) Vs. Twice-Daily Tacrolimus (Prograf): Results from A Phase 3, Double-Blind, Double- Dummy, Multi-Center, Randomized Trial
      K. Budde, H.T. Silva, S.M. Steinberg, N. Kamar
    • Abst.A210, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
      Rapid Attainment of Tacrolimus Trough Levels Early Post-Transplant Reduces Risk of Treatment Failure in De Novo Kidney Transplant Patients: A Covariate Analysis of a Phase 3 Double-Blind Study
      J.M. Grinyo, L. Rostaing, K. Budde, K. Ciechanowski, S. Bunnapradist, H.T. Silva
    • Abst.A207, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
      Higher Starting Dose and Rapid Attainment of Tacrolimus Blood Levels with Envarsus Vs. Prograf is Not Associated with Increased Toxicity: Exploratory Analysis of A Phase 3, Double-Blind, Double- Dummy, Multi-Center, Randomized, Prospective Study of Envarsus (Once-daily MeltDose Tacrolimus Tablets) Vs. Prograf (Twice-daily Tacrolimus Capsules)
      H.T. Silva, S. Bunnapradist, S.M. Steinberg
    • Abst. A2978, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
      Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study
      L. Rostaing, K. Ciechanowski, S. Bunnapradist, H.T. Silva, J.M. Grinyo, K. Budde,

Suphamai Bunnapradist, M.D., professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, California, USA., said, “The African-American kidney transplant population has been a particularly challenging one to manage and unfortunately we have not been able to bring clinical outcomes to the same level as other transplant patient groups. The results of this pooled analysis suggest that a once-daily formulation of tacrolimus with improved pharmacokinetics and better bioavailability may improve clinical outcomes in these patients. This would be the first important clinical advance for African-American transplant patients in many years. Additional studies with Envarsus XR are being conducted and planned in this population group and we look forward to gaining further understanding.”

William Polvino, M.D., president and chief executive officer of Veloxis said, “We are developing Envarsus XR to improve the care and quality of life of organ transplant patients. Results to date have shown that Envarsus XR, based on our proprietary MeltDose formulation technology, improves the pharmacokinetic profile of tacrolimus enabling once-daily dosing and more stable and steady blood levels. The results presented at the World Transplant Congress suggest that this profile may translate into differential clinical results compared to other formulations of tacrolimus. Envarsus XR is now under regulatory review in the U.S. and we look forward to bringing this potentially important new medicine to patients.”

For Investor and media contact:

John Weinberg, M.D.
Phone: +1 908 304 3389
Email: jdw@veloxis.com

Johnny Stilou
Phone: + 45 21 227 227
Email: jst@veloxis.com

The National Kidney Foundation (NKF) is the leading organization in the U.S. dedicated to the awareness, prevention and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk. For more information, visit www.kidney.org.