Veloxis Pharmaceuticals A/S
U.S. District Court Sets Briefing Schedule in Veloxis Litigation
Veloxis Pharmaceuticals A/S 14.01.2015 19:53 Dissemination of a Adhoc News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- 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(R) 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(R) Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus(R) (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(R), known as Envarsus(R) 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(R) XR has received orphan drug designation in the U.S. Veloxis plans to commercialize Envarsus(R) 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(R), 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. News Source: NASDAQ OMX 14.01.2015 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Veloxis Pharmaceuticals A/S Denmark Phone: Fax: E-mail: Internet: ISIN: DK0060048148 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------
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