Sucroferric oxyhydroxide

EQS-News: How One Company Plans To Help Battle A Silent Killer Globally Through Its New Kidney Disease Medication

Retrieved on: 
Friday, September 23, 2022

Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.

Key Points: 
  • Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.
  • In fact, each year, more people die from this silent killer than from breast or prostate cancer.
  • Hyperphosphatemia (elevated phosphorus levels in the blood) is a common complication of CKD affecting over 80% of dialysis patients.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.

VFMCRP announces U.S. Court upholds validity of Velphoro® patent

Retrieved on: 
Monday, August 22, 2022

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.

Key Points: 
  • Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.
  • Currently, Velphoro is protected by multiple Orange Book listed patents which expire between May 2029 and May 2035.
  • View the full release here: https://www.businesswire.com/news/home/20220821005007/en/
    A further ANDA patent infringement lawsuit against Teva based on patents no.
  • CSL Vifor welcomes the decision by the U.S. District Court to uphold the patent validity of Velphoro which highlights the innovation and strength of our intellectual property, said Florian Jehle, Chief Executive Officer of VFMCRP.

VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China

Retrieved on: 
Friday, April 30, 2021

The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.\nDr.

Key Points: 
  • The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.\nDr.
  • In 2020, Velphoro\xc2\xae became a global leader by value in the calcium-free phosphate binder market2.\n1 Zhang et al.
  • Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives.
  • Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210429005950/en/\n'

Ardelyx Launches 'Can We Do Better?' Campaign at ASN's Kidney Week 2020

Retrieved on: 
Thursday, October 22, 2020

Campaign at Kidney Week 2020 , this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway.

Key Points: 
  • Campaign at Kidney Week 2020 , this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway.
  • With a new and deeper mechanistic understanding of phosphate absorption, Ardelyx is developing a new approach to advance patient care.
  • THE PROBLEM: Hyperphosphatemia has been shown to be an independent risk factor for high rates of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) on dialysis.
  • Ardelyx is a biopharmaceutical company translating scientific breakthroughs into promise for patients, driven to advance targeted therapies where significant medical needs persist.

New Retrospective Two-Year Study Demonstrates Velphoro® Effectiveness

Retrieved on: 
Tuesday, March 31, 2020

"Previous real world studies have shown similar results with Velphoro, but lacked a control group," said first study author Dr. Daniel Coyne, Professor of Medicine, Washington University School of Medicine St Louis.

Key Points: 
  • "Previous real world studies have shown similar results with Velphoro, but lacked a control group," said first study author Dr. Daniel Coyne, Professor of Medicine, Washington University School of Medicine St Louis.
  • "This two-year analysis addresses that problem, and shows marked improvements with Velphoro that are not achieved using other phosphorus binders."
  • Velphoro is a non-calcium, chewable, iron-based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
  • Velphoro has a high phosphate-binding capacity relative to equivalent doses of other commonly prescribed phosphate binders and the iron in Velphoro is minimally absorbed.

Ardelyx Announces Positive Topline Results from Pivotal Phase 3 PHREEDOM Study Evaluating Tenapanor in CKD Patients on Dialysis

Retrieved on: 
Tuesday, December 3, 2019

Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.

Key Points: 
  • Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.
  • If approved, tenapanor will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.
  • Patients entering the study from the tenapanor arm with serum phosphorus levels in the normal range are followed with no medication changes.
  • In addition to the positive results of the PHREEDOM trial, the company previously reported results from its first Phase 3 monotherapy study with tenapanor in patients with CKD on dialysis, reporting that the primary endpoint was met (p=0.01).

Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment

Retrieved on: 
Tuesday, September 3, 2019

Tenapanor is an investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.

Key Points: 
  • Tenapanor is an investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.
  • The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach."
  • We look forward to reporting results from our second Phase 3 monotherapy study, PHREEDOM, in the fourth quarter of this year.
  • The promising results from AMPLIFY bring us one step closer to providing this important medicine to patients with CKD on dialysis."

US Nephrologists Report Few Gains in the CKD-MBD Market for Akebia's Auryxia, Amgen's Parsabiv, and Opko's Rayaldee Despite Reports That They Would Like to Expand Use of All Three Products

Retrieved on: 
Tuesday, June 25, 2019

Use of sevelamer (Renvela/sevelamer generics) has held steady during this time, although nephrologists do report projected offsets in favor of Auryxia and Velphoro in the near future.

Key Points: 
  • Use of sevelamer (Renvela/sevelamer generics) has held steady during this time, although nephrologists do report projected offsets in favor of Auryxia and Velphoro in the near future.
  • Spherix quarterly updates for the renal anemia market are scheduled to be released this week.
  • Subscriptions to the service are available for the following markets: Bone and Mineral Metabolism, Renal Anemia, Hyperkalemia, and Polycystic Kidney Disease.
  • All company, brand or product names in this document are trademarks of their respective holders.

Vifor Pharma and Akebia Therapeutics Announce Expansion of License Agreement

Retrieved on: 
Tuesday, April 9, 2019

Vifor Pharma and Akebia believe that vadadustat has the potential to set a new oral standard of care for patients with anemia due to CKD.

Key Points: 
  • Vifor Pharma and Akebia believe that vadadustat has the potential to set a new oral standard of care for patients with anemia due to CKD.
  • The Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives.
  • The Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
  • Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialisation of therapeutics for patients with kidney disease.

Vifor Pharma and Akebia Therapeutics Announce Expansion of Licence Agreement

Retrieved on: 
Tuesday, April 9, 2019

Under the terms of the agreement signed in May 2017, Akebia granted Vifor Pharma a licence to sell vadadustat to Fresenius Medical Care North America for use solely within its dialysis clinics in the U.S., subject to FDA approval.

Key Points: 
  • Under the terms of the agreement signed in May 2017, Akebia granted Vifor Pharma a licence to sell vadadustat to Fresenius Medical Care North America for use solely within its dialysis clinics in the U.S., subject to FDA approval.
  • Vifor Pharma and Akebia believe that vadadustat has the potential to set a new oral standard of care for patients with anaemia due to CKD.
  • The Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
  • Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialisation of therapeutics for patients with kidney disease.