Latest Veloxis Pharmaceuticals Stories
HORSHOLM, Denmark, May 21, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that the European Medicines Agency (EMA) accepted for review the company's Marketing Authorization Application (MAA) to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union. Veloxis expects the decision from the European Union in 2014. For Investor and media contact: John Weinberg, M.D. EVP & Chief Commercial Officer...
Data from the STRATO Study Presented at the 13th American Transplant Congress HORSHOLM, Denmark, May 20, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from the STRATO study demonstrates the potential for LCP-Tacro(TM) to improve tacrolimus-induced tremors in stable kidney transplant patients. The study, Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO(TM) (STRATO) clinical trial, was presented at the 13(th) American...
HORSHOLM, Denmark, May 15, 2013 /PRNewswire/ -- Highlights: On 29 April, 2013 Veloxis submitted the MAA to the European Medicines Agency (EMA) seeking approval to market LCP-Tacro(TM) 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(TM) Phase III 3001 study in stable kidney transplant patients and data from an extensive Phase I and II clinical program. Veloxis expects...
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...
HORSHOLM, Denmark, March 6, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2012. The annual report has been prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional Danish disclosure requirements for annual reports of listed companies. This company announcement should be read in conjunction with Veloxis' annual report...
HORSHOLM, Denmark, Jan. 3, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S today is announcing that the LCP-Tacro Phase III clinical trial in stable kidney transplant patients, the 3001 study, has been published online in the American Journal of Transplantation. The article reports on the randomized, controlled, multicenter Phase III trial, which demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf(®), dosed twice-daily....
HORSHOLM, Denmark, Dec. 6, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced results of a preliminary analysis from the first 16 patients in its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro. "Tremor is a common side effect of tacrolimus administration...
HORSHOLM, Denmark, Nov. 14, 2012 /PRNewswire/ -- Highlights: Veloxis has in October 2012 entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro in certain countries, including Europe, Turkey and CIS countries (Russia and former USSR...
HORSHOLM, Denmark, Oct. 10, 2012 /PRNewswire/ -- Veloxis will give two upcoming data presentations that further define the profile of LCP-Tacro compared to other tacrolimus formulations. The first study demonstrates the potentially flexible dosing that may improve dosing convenience for transplant patients. A second study demonstrates the enhanced bioavailability of tacrolimus driven by LCP-Tacro's proprietary formulation, compared to another once-daily tacrolimus formulation, which...
HORSHOLM, Denmark, Oct. 5, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that it has entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro in certain countries, including Europe, Turkey and CIS countries....
