Veloxis' Phase 3 Trial of LCP-Tacro™ in Stable Kidney Transplant Patients, the 3001 Study, Published Online in the American

Veloxis' Phase 3 Trial of LCP-Tacro™ in Stable Kidney Transplant Patients, the
   3001 Study, Published Online in the American Journal of Transplantation

PR Newswire

HORSHOLM, Denmark, Jan. 3, 2013

HORSHOLM, Denmark, Jan. 3, 2013 /PRNewswire/ --Veloxis Pharmaceuticals A/S
today is announcing that the LCP-Tacro Phase III clinical trial in stable
kidney transplant patients, the 3001 study, has been published online in the
American Journal of Transplantation. The article reports on the randomized,
controlled, multicenter Phase III trial, which demonstrated that LCP-Tacro
dosed once-daily was not inferior to the current leading transplant drug,
Prograf^®, dosed twice-daily. Non-inferiority was determined by a composite
endpoint, measured over a year of follow up that included death, graft
failure, biopsy-proven acute rejection or loss to follow-up.

Results of this trial demonstrated that patients can be successfully converted
from twice-daily Prograf to once-daily LCP-Tacro, which may increase patient
compliance. Non-adherence to drug regimens is a contributor to graft failure
(Prog. Transplant, 19:277-284, 2009). The results also demonstrated that, over
the 12 month study, the daily dose of LCP-Tacro could be lowered significantly
compared to the baseline Prograf dose, while the target blood levels remained
stable and within target range. This reflected the enhanced bioavailability
provided by Veloxis' proprietary MeltDose® formulation. The technology
optimizes the formulation and delivery characteristics of the LCP-Tacro
product to permit once daily dosing.

"Our study showed that  LCP-Tacro may be a safe and effective once-daily
formulation for preventing rejection, and an alternative to currently
available twice-daily tacrolimus," said Suphamai Bunnapradist, M.D., Professor
of Medicine at David Geffen School of Medicine at UCLA. "LCP-Tacro required
lower doses to achieve target levels in the blood, had similar rates of
adverse events, and demonstrated non-inferiority to the twice daily regimen of
tacrolimus in stable patients."

William Polvino, M.D. and chief executive officer of Veloxis added, "We have
reached another milestone by the publication of the 3001 study in the American
Journal of Transplantation. We are now looking forward to completing the 3002
study in de novo kidney transplant patients and releasing top-line data in

For Investor and media contact:

John Weinberg, M.D.
EVP & Chief Commercial Officer
Phone: +1 732 321 3208

About LCP‐Tacro™ and tacrolimus

Tacrolimus is a leading immunosuppression drug used for the prevention of
transplant allograft rejection after organ transplantation. LCP‐Tacro™ is an
investigational drug that it is being developed as a once‐daily tablet version
of tacrolimus, with improved bioavailability, consistent pharmacokinetic
performance and reduced peak‐to‐trough variability when compared to currently
approved tacrolimus products. Transplant patients need to maintain a minimum
blood level of tacrolimus for the prevention of transplant allograft
rejection, but excessive levels may increase the risk of serious side effects
such as nephrotoxicity, tremor, diabetes, high blood pressure, and
opportunistic infections. Therefore, tacrolimus levels need to be managed
carefully, and transplant patients are typically obliged to make frequent
visits to the hospital for monitoring and dose adjustments after receiving a
new organ.

About Veloxis Pharmaceuticals

Based in Horsholm, Denmark, with an office in New Jersey, Veloxis
Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The
company's lead product candidate is LCP‐Tacro™ for immunosuppression,
specifically organ transplantation. Veloxis' unique, patented delivery
technology, MeltDose^®, can improve absorption and bioavailability at
low‐scale up costs. Veloxis has a lipid lowering product, Fenoglide^®,
currently on the U.S. market that is commercialized through partner Santarus,
Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol

For further information, please visit

SOURCE Veloxis Pharmaceuticals A/S

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