Veloxis Announces Submission of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) for LCP-Tacro™ for Treatment of Kidney Transplant Patients

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Apr 29, 2013, 07:49 ET

HORSHOLM, Denmark, April 29, 2013 /PRNewswire/ -- 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.

For Investor and media contact:
John Weinberg, M.D.
EVP & Chief Commercial Officer
Phone: +1 732 321 3208
Email: [email protected]

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 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 OMX: VELO.

For further information, please visit www.veloxis.com.

SOURCE Veloxis Pharmaceuticals