Veloxis Pharmaceutic (LFCYF) 0.3290 $LFCYF
Envarsus® Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients
PR Newswire - Mon Jul 28, 1:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
Envarsus® XR Demonstrates Lower Treatment Failure Rate in African-Americans Compared to Twice-Daily Tacrolimus (Prograf®)
PR Newswire - Mon Jun 30, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled "Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules." The presentation will occur at 6:30 pm - 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.
Veloxis Announces Positive Two-Year Results from Pivotal Phase 3 Study of Envarsus® XR (tacrolimus extended-release tablets) in de novo Kidney Transplant Patients
PR Newswire - Mon Jun 23, 10:50AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma). Data will be presented in a late-breaker session at the World Transplant Congress (WTC) in San Francisco, entitled "Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study" at 6:30 p.m. PDT on July 27th.
U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients
PR Newswire - Thu Mar 13, 12:44PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients. Envarsus® is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology.
Veloxis Promotes John Weinberg to Chief Operating Officer
PR Newswire - Thu Mar 06, 8:48AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that John Weinberg, M.D., currently chief commercial officer of Veloxis, has been promoted to chief operating officer.
Veloxis Pharmaceuticals publishes Annual Report 2013
PR Newswire - Wed Mar 05, 7:02AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis'
today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2013. 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.
Veloxis Pharmaceuticals Receives Notice of Allowance from U.S. Patent Office for Diurnal-Independent Administration of Envarsus®
PR Newswire - Wed Jan 08, 10:25AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus®.
Veloxis Pharmaceuticals Announces NDA Submission for Envarsus® in Kidney Transplant Recipients
PR Newswire - Mon Dec 30, 2:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly LCP-Tacro(TM)) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and enrolled over 1000 patients, including two pivotal clinical trials, studies 3001 and 3002. In the two pivotal trials, Envarsus® given once-daily met the primary endpoint of demonstrating comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®, Astellas Pharma, Inc.). In the largest study, Study 3002, Envarsus® was shown to have a primary efficacy failure rate of 18.3% vs 19.6% with Prograf therapy. The differences between the treatments was well-within the pre-defined 10% non-inferiority margin. The study was conducted under a Special Protocol Agreement with the FDA. Envarsus® has been granted Orphan Drug status by the FDA for prophylaxis of rejection for kidney transplant recipients.
Veloxis Pharmaceuticals Envarsus® Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
PR Newswire - Tue Dec 24, 6:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus® was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. Envarsus® is Veloxis' once-daily formulation of tacrolimus employing the company's proprietary MeltDose® technology.
Phase III Clinical Study Data Demonstrating LCP-Tacro(TM)'s Comparable Efficacy and Safety to Twice-Daily Tacrolimus Presented at the European Society for Organ Transplantation
PR Newswire - Wed Sep 04, 7:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from the 3002, randomized, double-blind, double-dummy, Phase III study in 543 de novo kidney transplant patients will be presented at the European Society for Organ Transplantation as a late-breaker oral presentation at 8:30 a.m. CEST, Sept. 9, in Vienna. Veloxis' once-daily LCP-Tacro(TM), now with the trade name of Envarsus®, demonstrated comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®).
Veloxis Announces Positive Results of 3002 Study: LCP-Tacro(TM) Meets Primary Efficacy and Safety Endpoints in de Novo Kidney Transplant Patients
PR Newswire - Thu Jun 27, 11:26AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced LCP-Tacro(TM) successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints. The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013.
European Medicines Agency (EMA) Accepts Veloxis' Marketing Authorization Application (MAA) for LCP-Tacro for Treatment of Kidney Transplant Patients
PR Newswire - Tue May 21, 3:30PM CDT
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.
Final STRATO Clinical Study Data Demonstrates Potential for LCP-Tacro(TM) to Improve Tacrolimus-Induced Tremors
PR Newswire - Mon May 20, 2:00AM CDT
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 13th American Transplant Congress, Abstract #B1022, on Sunday, May 19, 2013 in Seattle.
Veloxis Announces Submission of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) for LCP-Tacro(TM) for Treatment of Kidney Transplant Patients
PR Newswire - Mon Apr 29, 6:49AM CDT
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.
Veloxis' Phase 3 Trial of LCP-Tacro(TM) in Stable Kidney Transplant Patients, the 3001 Study, Published Online in the American Journal of Transplantation
PR Newswire - Thu Jan 03, 7:00AM CST
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. 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.
Envarsus® Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients
PR Newswire - Mon Jul 28, 1:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
Envarsus® XR Demonstrates Lower Treatment Failure Rate in African-Americans Compared to Twice-Daily Tacrolimus (Prograf®)
PR Newswire - Mon Jun 30, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled "Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules." The presentation will occur at 6:30 pm - 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.
Veloxis Announces Positive Two-Year Results from Pivotal Phase 3 Study of Envarsus® XR (tacrolimus extended-release tablets) in de novo Kidney Transplant Patients
PR Newswire - Mon Jun 23, 10:50AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma). Data will be presented in a late-breaker session at the World Transplant Congress (WTC) in San Francisco, entitled "Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study" at 6:30 p.m. PDT on July 27th.
U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients
PR Newswire - Thu Mar 13, 12:44PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients. Envarsus® is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology.
Veloxis Promotes John Weinberg to Chief Operating Officer
PR Newswire - Thu Mar 06, 8:48AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that John Weinberg, M.D., currently chief commercial officer of Veloxis, has been promoted to chief operating officer.
Veloxis Pharmaceuticals publishes Annual Report 2013
PR Newswire - Wed Mar 05, 7:02AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis'
today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2013. 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. Veloxis Pharmaceuticals Receives Notice of Allowance from U.S. Patent Office for Diurnal-Independent Administration of Envarsus®
PR Newswire - Wed Jan 08, 10:25AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus®.
Veloxis Pharmaceuticals Announces NDA Submission for Envarsus® in Kidney Transplant Recipients
PR Newswire - Mon Dec 30, 2:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly LCP-Tacro(TM)) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and enrolled over 1000 patients, including two pivotal clinical trials, studies 3001 and 3002. In the two pivotal trials, Envarsus® given once-daily met the primary endpoint of demonstrating comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®, Astellas Pharma, Inc.). In the largest study, Study 3002, Envarsus® was shown to have a primary efficacy failure rate of 18.3% vs 19.6% with Prograf therapy. The differences between the treatments was well-within the pre-defined 10% non-inferiority margin. The study was conducted under a Special Protocol Agreement with the FDA. Envarsus® has been granted Orphan Drug status by the FDA for prophylaxis of rejection for kidney transplant recipients.
Veloxis Pharmaceuticals Envarsus® Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
PR Newswire - Tue Dec 24, 6:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus® was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. Envarsus® is Veloxis' once-daily formulation of tacrolimus employing the company's proprietary MeltDose® technology.
Phase III Clinical Study Data Demonstrating LCP-Tacro(TM)'s Comparable Efficacy and Safety to Twice-Daily Tacrolimus Presented at the European Society for Organ Transplantation
PR Newswire - Wed Sep 04, 7:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from the 3002, randomized, double-blind, double-dummy, Phase III study in 543 de novo kidney transplant patients will be presented at the European Society for Organ Transplantation as a late-breaker oral presentation at 8:30 a.m. CEST, Sept. 9, in Vienna. Veloxis' once-daily LCP-Tacro(TM), now with the trade name of Envarsus®, demonstrated comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®).
Veloxis Announces Positive Results of 3002 Study: LCP-Tacro(TM) Meets Primary Efficacy and Safety Endpoints in de Novo Kidney Transplant Patients
PR Newswire - Thu Jun 27, 11:26AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced LCP-Tacro(TM) successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints. The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013.
European Medicines Agency (EMA) Accepts Veloxis' Marketing Authorization Application (MAA) for LCP-Tacro for Treatment of Kidney Transplant Patients
PR Newswire - Tue May 21, 3:30PM CDT
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.
Final STRATO Clinical Study Data Demonstrates Potential for LCP-Tacro(TM) to Improve Tacrolimus-Induced Tremors
PR Newswire - Mon May 20, 2:00AM CDT
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 13th American Transplant Congress, Abstract #B1022, on Sunday, May 19, 2013 in Seattle.
Veloxis Announces Submission of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) for LCP-Tacro(TM) for Treatment of Kidney Transplant Patients
PR Newswire - Mon Apr 29, 6:49AM CDT
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.
Veloxis' Phase 3 Trial of LCP-Tacro(TM) in Stable Kidney Transplant Patients, the 3001 Study, Published Online in the American Journal of Transplantation
PR Newswire - Thu Jan 03, 7:00AM CST
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. 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.
