Veloxis Pharmaceutic (LFCYF) 0.1900 $LFCYF
Kidney Transplantation - Pipeline Review, H1 2014
M2 - Tue Apr 29, 8:23AM CDT
Research and Markets (http://www.researchandmarkets.com/research/sxcd3n/kidney) has announced the addition of the "Kidney Transplantation - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Kidney Transplantation, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Kidney Transplantation and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Kidney Transplantation - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Kidney Transplantation and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Kidney Transplantation products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Kidney Transplantation pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Mentioned - GlaxoSmithKline plc - Quark Pharmaceuticals, Inc. - Pharming Group N.V. - Astellas Pharma Inc. - Shire Plc - 4SC AG - Veloxis Pharmaceuticals A/S - NPS Pharmaceuticals, Inc. - La Jolla Pharmaceutical Company - Alexion Pharmaceuticals, Inc. - Hansa Medical AB - Digna Biotech, S.L. - Viron Therapeutics, Inc. - Opsona Therapeutics Ltd. - Angion Biomedica Corp. - NovImmune SA - Tolera Therapeutics, Inc. - Pharmicell Co., Ltd. For more information visit http://www.researchandmarkets.com/research/sxcd3n/kidney
Veloxis Announces Scientific Publication of Phase II Study Demonstrating Conversion from Twice-Daily Tacrolimus to Once-Daily Envarsus® in Liver Transplant Patients
PR Newswire - Mon Apr 28, 10:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of a Phase II study demonstrating conversion from twice-daily tacrolimus to once-daily Envarsus® in stable liver transplant patients in Liver Transplantation.
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.
Veloxis Pharmaceuticals Announces Initiation of ASERTAA Study of ENVARSUS® in African-American Kidney Transplant Recipients
PR Newswire - Wed Dec 11, 7:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of ENVARSUS® (formerly LCP Tacro(TM)) in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of ENVARSUS®, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal transplant patients.
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.
Kidney Transplantation - Pipeline Review, H1 2014
M2 - Tue Apr 29, 8:23AM CDT
Research and Markets (http://www.researchandmarkets.com/research/sxcd3n/kidney) has announced the addition of the "Kidney Transplantation - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Kidney Transplantation, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Kidney Transplantation and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Kidney Transplantation - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Kidney Transplantation and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Kidney Transplantation products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Kidney Transplantation pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Mentioned - GlaxoSmithKline plc - Quark Pharmaceuticals, Inc. - Pharming Group N.V. - Astellas Pharma Inc. - Shire Plc - 4SC AG - Veloxis Pharmaceuticals A/S - NPS Pharmaceuticals, Inc. - La Jolla Pharmaceutical Company - Alexion Pharmaceuticals, Inc. - Hansa Medical AB - Digna Biotech, S.L. - Viron Therapeutics, Inc. - Opsona Therapeutics Ltd. - Angion Biomedica Corp. - NovImmune SA - Tolera Therapeutics, Inc. - Pharmicell Co., Ltd. For more information visit http://www.researchandmarkets.com/research/sxcd3n/kidney
Veloxis Announces Scientific Publication of Phase II Study Demonstrating Conversion from Twice-Daily Tacrolimus to Once-Daily Envarsus® in Liver Transplant Patients
PR Newswire - Mon Apr 28, 10:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of a Phase II study demonstrating conversion from twice-daily tacrolimus to once-daily Envarsus® in stable liver transplant patients in Liver Transplantation.
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.
Veloxis Pharmaceuticals Announces Initiation of ASERTAA Study of ENVARSUS® in African-American Kidney Transplant Recipients
PR Newswire - Wed Dec 11, 7:00AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of ENVARSUS® (formerly LCP Tacro(TM)) in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of ENVARSUS®, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal transplant patients.
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.
