Veloxis Comments on U.S. District Court Order

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Dec 19, 2014, 09:41 ET

HORSHOLM, Denmark, Dec. 19, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action Veloxis filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus^®XR:

"We are pleased that the Court recognizes our need for an expedited resolution of this matter, and has indicated that it will set a briefing timetable that will result in the matter being fully briefed in a timely fashion. We had previously requested and anticipated that approximately 2 months would be required to achieve a full briefing under the strategy Veloxis had proposed, and we are pleased to see the court Order reflecting consistency with this timeline."

Envarsus XR is a once-daily extended-release tablet indicated for prophylaxis of organ rejection in kidney transplant patients. Although Envarsus XR has been found to be safe and effective, FDA determined that the period of statutory exclusivity granted to another extended-release tacrolimus product, Astagraf XL®, blocks Envarsus XR from being sold in the United States until that exclusivity period expires (July 2016) as previously announced by the Company on October 31, 2014.

Veloxis believes that FDA's action is contrary to the requirements of the controlling statute, its regulations and longstanding agency precedent. Its lawsuit seeks a determination by the Court that Envarsus XR should be immediately approved for sale in the United States. There can be no assurance that Veloxis will be successful in its action against FDA.

For more information, please contact:
Veloxis Pharmaceuticals A/S
William J. Polvino
President & CEO
Tel: +1 732 321 3202
Email: [email protected]

About Envarsus®
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus® (tacrolimus prolonged-release tablets) has received marketing authorization in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients. In the US, Envarsus®, known as Envarsus® XR (tacrolimus extended-release tablets), has received Tentative Approval as a once-daily tablet version of tacrolimus for prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants. Envarsus® XR has received orphan drug designation in the U.S. Veloxis plans to commercialize Envarsus® XR in the US through its own sales force and in the EU through its partnership with Chiesi Farmaceutici SpA.

About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. Veloxis' unique, patented delivery technology, MeltDose®, is designed to enhance the absorption and bioavailability of select orally administered drugs. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.

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

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SOURCE Veloxis Pharmaceuticals