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Pipeline Analysis on Glomerulonephritis Reviewed by Company, Profiled Drugs and Therapeutic Development Glomerulonephritis is also known as glomerular nephritis (GN) or glomerular disease. It is a disease of the kidney, characterized by inflammation of the glomeruli. Albany, NY, May 17, 2017 --( The report provides a detailed analysis of Glomerulonephritis by main industries and major drugs. Request Free Sample Report: http://www.marketresearchhub.com/enquiry.php?type=S&repid=1068016 Glomerulonephritis is medical disease that damages the part of the kidney that filters blood. It is a serious illness that can be life-threatening and requires immediate treatment, the condition is of two type that includes acute, and chronic. The early symptoms of acute glomerulonephritis are puffiness of face in the morning, blood in the urine and urinating less than usual. The chronic form may develop silently over several years that consequently leads to complete kidney failure. The chronic form symptoms include blood or protein in the urine, high blood pressure, swelling of your ankles or face, frequent urination during night time and very bubbly or foamy urine. The report starts with the Glomerulonephritis overview and its therapeutics development. Further, the companies and universities/institutes are considered for this pipeline analysis; and are overviewed along with the products under development by the companies and universities. The glomerulonephritis therapeutics are further assessed by the target, mechanism of action, route of administration and molecular type. Moving on, the leading companies involved in therapeutic development for glomerulonephritis are listed with top players including Achillion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Anthera Pharmaceuticals Inc., Biogen Inc., BLR Bio LLC, ChemoCentryx Inc., Dimerix Bioscience Pty Ltd, GlaxoSmithKline Plc, Mallinckrodt Plc, Omeros Corp, Pfizer Inc., Pharmalink AB, Ra Pharmaceuticals Inc., Retrophin Inc., Rigel Pharmaceuticals Inc., Shire Plc and Visterra Inc. Browse Full Report with TOC - http://www.marketresearchhub.com/report/glomerulonephritis-pipeline-review-h1-2017-report.html This detailed study also includes the major drugs listed for glomerulonephritis that consist of (irbesartan + propagermanium), ACH-4471, AMY-101, AVX-002, BaxB-01, BaxG-03, belimumab, blisibimod, BLR-400, budesonide, CCX-140, corticotropin, eculizumab, fostamatinib disodium, iosmapimod, monoclonal antibodies to inhibit ITGAM for cardiovascular, immunology and Kidney Diseases. The other drugs are OMS-721, PF-1355, recombinant enzyme for immunoglobulin, rituximab, SHP-627, sparsentan, TM-5484, vaccine to target CD40 for membranous glomerulonephritis, VAR-200, VIS-649, small molecule to inhibit factor D for PNH and dense deposit disease, and other. The report is followed by the press release and news that further provide the facts andfigures for Glomerulonephritis and concluded with the list of tables that elaborate the research. About Market Research Hub Market Research Hub (MRH) is a next-generation reseller of research reports and analysis. MRH’s expansive collection of market research reports has been carefully curated to help key personnel and decision makers across industry verticals to clearly visualize their operating environment and take strategic steps. MRH functions as an integrated platform for the following products and services: Objective and sound market forecasts, qualitative and quantitative analysis, incisive insight into defining industry trends, and market share estimates. Our reputation lies in delivering value and world-class capabilities to our clients. Albany, NY, May 17, 2017 --( PR.com )-- According to a latest pipeline assessment on the Glomerulonephritis, it has been analysed that the main factors that result in glomerulonephritis are family history, strep throat, immune diseases, such as lupus, type 1 & type 2 diabetes and viruses, such as hepatitis B virus, HIV and hepatitis C virus. The rapid increase in these factors has directly augmented the glomerulonephritis disease. Recently, a detailed analysis has been added to Market Research Hub’s vast database (MRH), and titled as “Glomerulonephritis - Pipeline Review, H1 2017.”The report provides a detailed analysis of Glomerulonephritis by main industries and major drugs.Request Free Sample Report: http://www.marketresearchhub.com/enquiry.php?type=S&repid=1068016Glomerulonephritis is medical disease that damages the part of the kidney that filters blood. It is a serious illness that can be life-threatening and requires immediate treatment, the condition is of two type that includes acute, and chronic. The early symptoms of acute glomerulonephritis are puffiness of face in the morning, blood in the urine and urinating less than usual. The chronic form may develop silently over several years that consequently leads to complete kidney failure. The chronic form symptoms include blood or protein in the urine, high blood pressure, swelling of your ankles or face, frequent urination during night time and very bubbly or foamy urine.The report starts with the Glomerulonephritis overview and its therapeutics development. Further, the companies and universities/institutes are considered for this pipeline analysis; and are overviewed along with the products under development by the companies and universities. The glomerulonephritis therapeutics are further assessed by the target, mechanism of action, route of administration and molecular type. Moving on, the leading companies involved in therapeutic development for glomerulonephritis are listed with top players including Achillion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Anthera Pharmaceuticals Inc., Biogen Inc., BLR Bio LLC, ChemoCentryx Inc., Dimerix Bioscience Pty Ltd, GlaxoSmithKline Plc, Mallinckrodt Plc, Omeros Corp, Pfizer Inc., Pharmalink AB, Ra Pharmaceuticals Inc., Retrophin Inc., Rigel Pharmaceuticals Inc., Shire Plc and Visterra Inc.Browse Full Report with TOC - http://www.marketresearchhub.com/report/glomerulonephritis-pipeline-review-h1-2017-report.htmlThis detailed study also includes the major drugs listed for glomerulonephritis that consist of (irbesartan + propagermanium), ACH-4471, AMY-101, AVX-002, BaxB-01, BaxG-03, belimumab, blisibimod, BLR-400, budesonide, CCX-140, corticotropin, eculizumab, fostamatinib disodium, iosmapimod, monoclonal antibodies to inhibit ITGAM for cardiovascular, immunology and Kidney Diseases. The other drugs are OMS-721, PF-1355, recombinant enzyme for immunoglobulin, rituximab, SHP-627, sparsentan, TM-5484, vaccine to target CD40 for membranous glomerulonephritis, VAR-200, VIS-649, small molecule to inhibit factor D for PNH and dense deposit disease, and other. The report is followed by the press release and news that further provide the facts andfigures for Glomerulonephritis and concluded with the list of tables that elaborate the research.About Market Research HubMarket Research Hub (MRH) is a next-generation reseller of research reports and analysis. MRH’s expansive collection of market research reports has been carefully curated to help key personnel and decision makers across industry verticals to clearly visualize their operating environment and take strategic steps.MRH functions as an integrated platform for the following products and services: Objective and sound market forecasts, qualitative and quantitative analysis, incisive insight into defining industry trends, and market share estimates. Our reputation lies in delivering value and world-class capabilities to our clients. Click here to view the list of recent Press Releases from Market Research Hub


News Article | May 18, 2017
Site: www.prnewswire.co.uk

Pharmalink has appointed Ms Aguiar-Lucander to lead the Company's expansion and strategic development, following the clinical success to date of Nefecon®: a Phase 3 ready compound with orphan designation. Ms Aguiar-Lucander will, in conjunction with the Pharmalink team, pursue a range of initiatives, including raising private or public capital for the Phase 3 trial, expanding the Company's development platform, in-licensing of additional compounds as well as partnering. Pharmalink's current CEO, Dr Johan Häggblad, will take on the role of COO and will continue to lead clinical and product development. Prior to joining Pharmalink Ms. Aguiar-Lucander was Partner and COO of Omega Fund Management, an international healthcare fund based in Boston. She was previously a Partner at the venture group of 3i Group plc, where she managed the European and US legacy healthcare and technology portfolios, and had responsibility for the group's public holdings. Prior to this Ms. Aguiar-Lucander was European Group Head and Managing Director at a US based global investment bank. She has more than 12 years of corporate finance experience, including merger and acquisitions, corporate restructurings and raising private and public capital for growth companies in Europe and the US. She has held senior management positions in a technology growth company and has significant corporate board experience in both private and public companies. Ms Aguiar-Lucander holds a BA in Finance from Stockholm School of Economics and a MBA from INSEAD. Lennart Hansson of Industrifonden, Pharmalink's lead investor representative, said: "We are delighted with the appointment of Renee as CEO at Pharmalink. Her appointment comes at a key time for the Company, now that it has completed its highly successful NEFIGAN Phase 2b clinical trial with Nefecon® in patients with IgA nephropathy at risk of end stage renal disease. This is an exciting time for Pharmalink, as it prepares for the start of its Phase 3 study with Nefecon®." "I am excited to take up the CEO position at Pharmalink and join a team which has achieved truly exciting clinical results in the NEFIGAN trial. The company is well positioned to see accelerated growth and expansion through work with clinicians, KOLs and regulators to bring products to the market which address unmet medical needs, and make a true difference to patients and their families." said Renee Aguiar-Lucander. Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit www.pharmalink.se for further information. Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon® has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned. Nefecon® is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs. For further information, please contact: Pharmalink AB: Renee Aguiar-Lucander Chief Executive Officer +46-(0)-72-252-1006 Email: renee.lucander@pharmalink.se Anders Hultman Chief Financial Officer, +46-(0)-76-629-6990 Email: www.pharmalink.se Citigate Dewe Rogerson (for Pharmalink): Mark Swallow/ Pip Batty +44-(0)-20-7638-9571 Email: pharmalink@citigatedr.co.uk


News Article | May 18, 2017
Site: www.prnewswire.com

Pharmalink has appointed Ms Aguiar-Lucander to lead the Company's expansion and strategic development, following the clinical success to date of Nefecon®: a Phase 3 ready compound with orphan designation. Ms Aguiar-Lucander will, in conjunction with the Pharmalink team, pursue a range of initiatives, including raising private or public capital for the Phase 3 trial, expanding the Company's development platform, in-licensing of additional compounds as well as partnering. Pharmalink's current CEO, Dr Johan Häggblad, will take on the role of COO and will continue to lead clinical and product development. Prior to joining Pharmalink Ms. Aguiar-Lucander was Partner and COO of Omega Fund Management, an international healthcare fund based in Boston. She was previously a Partner at the venture group of 3i Group plc, where she managed the European and US legacy healthcare and technology portfolios, and had responsibility for the group's public holdings. Prior to this Ms. Aguiar-Lucander was European Group Head and Managing Director at a US based global investment bank. She has more than 12 years of corporate finance experience, including merger and acquisitions, corporate restructurings and raising private and public capital for growth companies in Europe and the US. She has held senior management positions in a technology growth company and has significant corporate board experience in both private and public companies. Ms Aguiar-Lucander holds a BA in Finance from Stockholm School of Economics and a MBA from INSEAD. Lennart Hansson of Industrifonden, Pharmalink's lead investor representative, said: "We are delighted with the appointment of Renee as CEO at Pharmalink. Her appointment comes at a key time for the Company, now that it has completed its highly successful NEFIGAN Phase 2b clinical trial with Nefecon® in patients with IgA nephropathy at risk of end stage renal disease. This is an exciting time for Pharmalink, as it prepares for the start of its Phase 3 study with Nefecon®." "I am excited to take up the CEO position at Pharmalink and join a team which has achieved truly exciting clinical results in the NEFIGAN trial. The company is well positioned to see accelerated growth and expansion through work with clinicians, KOLs and regulators to bring products to the market which address unmet medical needs, and make a true difference to patients and their families." said Renee Aguiar-Lucander. Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit www.pharmalink.se for further information. Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon® has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned. Nefecon® is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs. For further information, please contact: Pharmalink AB: Renee Aguiar-Lucander Chief Executive Officer +46-(0)-72-252-1006 Email: renee.lucander@pharmalink.se Anders Hultman Chief Financial Officer, +46-(0)-76-629-6990 Email: www.pharmalink.se Citigate Dewe Rogerson (for Pharmalink): Mark Swallow/ Pip Batty +44-(0)-20-7638-9571 Email: pharmalink@citigatedr.co.uk


Title: Effects of a novel targeted release formulation of budesonide vs. placebo in IgA nephropathy: The NEFIGAN randomised clinical trial. Prof. Fellström will give a second presentation of results from the NEFIGAN trial at the conference. Title:Proteinuria reduction in IgA nephropathy by Nefecon, a targeted release formulation of budesonide - results from the NEFIGAN trial Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit http://www.pharmalink.se for further information. Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon® has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned. Nefecon® is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The NEFIGAN trial was randomized, double-blinded, and placebo-controlled in male and female patients (aged ≥18 years) with primary IgAN and overt proteinuria considered at risk of progressing to end-stage renal disease (ESRD). The trial was conducted at 62 sites across 10 European countries between November 2012 and June 2015. Data from 149 patients constituted the final analysis set, from a total of 249 patients screened. IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.


Title: Effects of a novel targeted release formulation of budesonide vs. placebo in IgA nephropathy: The NEFIGAN randomised clinical trial. Prof. Fellström will give a second presentation of results from the NEFIGAN trial at the conference. Title:Proteinuria reduction in IgA nephropathy by Nefecon, a targeted release formulation of budesonide - results from the NEFIGAN trial Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit http://www.pharmalink.se for further information. Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon® has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned. Nefecon® is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The NEFIGAN trial was randomized, double-blinded, and placebo-controlled in male and female patients (aged ≥18 years) with primary IgAN and overt proteinuria considered at risk of progressing to end-stage renal disease (ESRD). The trial was conducted at 62 sites across 10 European countries between November 2012 and June 2015. Data from 149 patients constituted the final analysis set, from a total of 249 patients screened. IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.


In The Lancet paper, published March 28, 2017, clinical data from the NEFIGAN trial are presented that demonstrate the clear potential of Nefecon, a novel, oral, targeted-release formulation of the corticosteroid budesonide, as a new treatment for patients with primary IgAN (a progressive inflammatory kidney disease and orphan indication with a high unmet need). The trial met its primary endpoint and concluded that the use of Nefecon, in addition to standardized rigorous blood pressure control (optimized RAS blockade), reduced proteinuria and stabilized estimated glomerular filtration rate (eGFR) in patients at risk of developing end-stage renal disease (ESRD). Both of these effects are indicative of a reduced risk of future progression to ESRD. Pharmalink is preparing to start pivotal Phase 3 studies of Nefecon in this indication. Renee Aguiar-Lucander, CEO of Pharmalink, said: "We are proud that the results of our positive Phase 2b trial have been selected for presentation in this prestigious forum. The study provides strong confirmation of the potential of Nefecon to become the first disease-specific treatment for primary IgAN. Our data suggest that Nefecon could delay disease progression, thereby minimizing any further loss of renal function and reducing the requirement for dialysis or kidney transplantation. We look forward to further evaluating the therapeutic potential of Nefecon in this orphan indication in the Phase 3 trial that we are currently planning." The full reference of the publication in The Lancet is: Fellstrӧm, BC, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomized, placebo-controlled phase 2b trial (2017) The Lancet, Vol. 389 (No. 10084) p2117-2127 http://dx.doi.org/10.1016/S0140-6736(17)30550-0 Prof. Fellström will give a further presentation of results from the NEFIGAN trial at the conference entitled "Proteinuria reduction in IgA nephropathy by Nefecon, a targeted release formulation of budesonide - results from the NEFIGAN trial," in the communication session "Glomerulonephritis" on June 6, 2017 between 8.00-9.30 CET in the Sala Neptuno. Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit www.pharmalink.se for further information. Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon®  has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned. Nefecon®  is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The NEFIGAN trial was randomized, double-blinded, and placebo-controlled in male and female patients (aged ≥18 years) with primary IgAN and overt proteinuria considered at risk of progressing to end-stage renal disease (ESRD). The trial was conducted at 62 sites across 10 European countries between November 2012 and June 2015. Data from 149 patients constituted the final analysis set, from a total of 249 patients screened. Following a 6-month run-in phase (to optimize RAS blockade treatment), patients underwent a 9-month treatment phase in which they were randomized in a 1:1:1 ratio to receive Nefecon at 16 mg/day, 8 mg/day or placebo. The primary outcome of the Phase 2b clinical trial was assessed on the full analysis set (n=149), defined as all randomized patients who took at least one dose of trial medication and had at least one post-dose efficacy measurement (modified intention-to-treat analysis). At nine months, mean urine protein creatinine ratio (UPCR) decreased by -26.4% with Nefecon [p=0.0066] (-29.3% with 16 mg/day [p=0.009], non-significant -23.7% with 8 mg/day [p=0.029]), vs. placebo. The effect was sustained throughout follow-up; mean UPCR decreased by -32% from baseline at 12 months for 16 mg/day vs. a 0.5% increase for placebo. Over nine months, eGFR was stable with Nefecon but decreased 9.8% with placebo (Nefecon vs. placebo: p=0.001). Nefecon was well tolerated and the total incidence of treatment-emergent adverse events was similar across all treatment groups. IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.


STOCKHOLM, November 29, 2016 /PRNewswire/ -- Pharmalink AB, a specialty pharma company, announces that the European Commission (EC) has granted Orphan Medicinal Product (OMP) designation in the European Union (EU) to Nefecon® (budesonide), the Company's treatment for patients with...


Pharmalink AB, a specialty pharma company, announces that the European Commission (EC) has granted Orphan Medicinal Product (OMP) designation in the European Union (EU) to Nefecon® (budesonide), the Company's treatment for patients with primary IgA nephropathy (IgAN). Nefecon, which already has orphan designation for IgAN in the US, has successfully completed a randomized, placebo-controlled Phase 2 study (the NEFIGAN trial) in more than 150 IgAN patients at risk of developing end stage renal disease (ESRD), under standardized rigorous blood pressure control. Full data and analysis of the trial is expected to be published in a peer-review journal. A Phase 3 registration trial is currently being planned. Johan Häggblad, Pharmalink CEO, commented: "Receiving orphan drug designation from the EC, in addition to the previous orphan drug designation granted by the US FDA, is an important event for Pharmalink. It highlights the need for new products for the treatment of primary IgAN as well as our commitment to developing Nefecon for these patients." Orphan drug designation is granted to drugs that are intended for the treatment of life threatening or chronically debilitating rare diseases where no therapeutic options either exist or are satisfactory. Rare diseases are those defined as having a prevalence of less than five in 10,000 in the European Union. The designation provides sponsors with development and commercial incentives, including 10 years of market exclusivity, prioritized consultation by the European Medicines Agency (EMA) on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees. Click here for more information. IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with IgAN progress to renal failure, often referred to as end-stage renal disease (ESRD) within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs. Nefecon is a treatment for patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD). Nefecon has successfully completed a randomized, placebo-controlled Phase 2b study in more than 150 IgAN patients at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB). Full data and analysis of the NEFIGAN trial is expected to be published in a peer-review journal. A Phase 3 registration trial is currently being planned. Nefecon is an oral formulation of a locally-acting and potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon may provide clinical benefits to IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon has received orphan drug designation by the US Food and Drug Administration (FDA). Pharmalink is a specialty pharma company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. For further information, please contact: Pharmalink AB: Johan Häggblad,


A method for manufacturing a hyaluronan conjugate comprises providing hyaluronan in solution or gel form, reacting the hyaluronan in solution or gel form with anhydride reagent to provide a hyaluronan hemi-ester with a chain of length L between the hyaluronan and the ester group, and subsequently binding the hyaluronan hemi-ester to a pharmaceutically active compound. A hyaluronan conjugate comprises hyaluronan having free hemi-ester-groups and a pharmaceutically active compound bound to the hyaluronan via hemi-ester groups, wherein the hemi-ester groups have a chain length of 2-9 atoms. The hyaluronan conjugate is suitable for use in various methods of treatment in human or veterinary medicine and for preparation of a medicament for use in human or veterinary medicine.


News Article | December 5, 2016
Site: www.prweb.com

PharmaLink is proud to partner with Miami-Luken, Inc., a leading regional wholesaler servicing independent pharmacies across multiple Midwestern states, on an innovative new solution to handle Unsaleable Pharmaceutical Returns for Pharmacy customers. The System OneSM returns program from PharmaLink provides Pharmacy customers with a simple, compliant, outlet to handle returns processing and reporting of unsaleable products with the ultimate convenience. Miami-Luken selected PharmaLink to work on this initiative because of their vast experience working with various Pharmacy classes of trade and their robust relationships throughout the pharmaceutical supply chain. Thierry Beckers (President/COO, PharmaLink) was noted saying, “We are excited about this new program because we will be providing independent pharmacy customers with services and reporting that delivers a new level of visibility to the returns process.” PharmaLink is known for their industry leading technology platform and boutique style services to handle pharmaceutical returns. Michael Faul (CEO, Miami-Luken) said, “We are always looking for innovative ways to provide our pharmacy customers with better solutions to their common problems. PharmaLink shares in a similar set of values to our organization and we are confident this new partnership will add significantly to our service offering.” The System One Returns program offers a robust suite of on-site and mail-in return services with no out of pocket expense to customers. Contact your Miami-Luken representative for details. Based in the Tampa Bay Area of Florida, PharmaLink, Inc. is the nation's premier Pharmaceutical Reverse Logistics and Disposal provider. With services spanning the complete spectrum of the pharmaceutical supply chain, they have a 360 degree view of the needs of all businesses involved in the delivery of healthcare. From a reverse logistics perspective, they deliver impactful solutions that trim cycle time while safely removing unwanted product from the marketplace. PharmaLink’s simple user interfaces are backed by a powerful enterprise infrastructure, producing accurate processing and quality analytics that optimize business decision and increase bottom line. This is all achieved while adhering to stringent regulatory guidelines at the state and federal level. PharmaLink has customizable solutions available for any size client. Centrally located in Ohio’s Miami Valley, Miami-Luken has been providing personal service and outstanding value to their customers since 1962. Miami-Luken offers full-line service of branded and generic pharmaceuticals, OTC items, private label products, home healthcare, health and beauty products, retail candy, and related items. These items are shipped daily to customers throughout Ohio, Indiana, Kentucky, Tennessee, West Virginia, western Pennsylvania and southern Michigan. Maintaining a variety of Industry Partnerships allows Miami-Luken to leverage the benefits of numerous programs and affiliations to meet the unique needs of their customers. Recently, Miami-Luken has been striving to provide innovative solutions to the challenges of the evolving healthcare industry, while expanding into new geographic territories. For additional information, visit http://www.miamiluken.com

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