Veloxis seeks EMA approval to market LCP-Tacro for kidney transplant patients

Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that it has 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.

The MAA submission is based on the favorable results of the LCP-Tacro Phase III 3001 study in stable kidney transplant patients and data from an extensive Phase I and II clinical program.  The 3001 study demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf® (tacrolimus), 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. In addition, 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 the 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.

"The MAA submission for LCP-Tacro is an important milestone for Veloxis as it demonstrates our commitment, along with our European marketing partner Chiesi Farmaceutici, to bring to market a safe and effective once-daily formulation of tacrolimus for preventing transplanted organ rejection," said William Polvino , M.D., chief executive officer of Veloxis. "We would like to thank all the investigators and patients that participated in our clinical trials and made the MAA submission possible."

In addition, Veloxis is awaiting results from a Phase III clinical trial in de novo kidney transplant patients, the 3002 study, which are expected mid-2013. Patient enrollment was completed in the first quarter of 2012, with 543 patients enrolled in this randomized, double-blind, multicenter study that compares once-daily LCP-Tacro against twice-daily Prograf in de novo adult kidney transplant patients. The primary endpoint of the study is a composite endpoint (biopsy-proven acute rejection, graft failure, loss to follow up or death) that will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf. Secondary endpoints will include safety, tolerability and renal function assessments. The study is being conducted at approximately 90 transplant centers, primarily in the United States and Europe. Patients will participate in a 12-month extension period on treatment for follow-up safety assessments. This study is not part of the current MAA submission.

The MAA submission will have no impact on the company's financial outlook for 2013.


Veloxis Pharmaceuticals


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