U.S. District Court Sets Briefing Schedule in Veloxis Litigation

Company Announcement no. 2/2015

To: NASDAQ OMX Copenhagen A/S                               Hørsholm, Denmark, 14 January 2015

U.S. District Court Sets Briefing Schedule in Veloxis Litigation

Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule that enables complete briefing in its pending case by March 3, 2015.  Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR.  While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur.  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: wjp@veloxis.com                      

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 Hørsholm, 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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140115 Veloxis Announces U.S. District Court Sets Briefing Schedule in Litigation.pdf