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Relypsa Announces Presentation of New Clinical and Real-World Analyses of Veltassa® at AMCP Nexus 2018

REDWOOD CITY, Calif., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, will present new data on Veltassa® (patiromer) at the Academy of Managed Care Pharmacy’s AMCP Nexus 2018 conference in Orlando, Florida, October 22-25. The new data reinforce the company’s commitment to understanding the real-world use and cost-effectiveness of Veltassa with the goal of improving the lives of patients with hyperkalemia or elevated blood potassium levels.

“Patients with hyperkalemia deserve quality care, yet long-term management can be challenging, especially in patients with other chronic conditions,” said Patrick Treanor, president (ad interim) of Relypsa. “Relypsa is committed to supporting studies that help evaluate patterns of usage and cost-effectiveness of Veltassa. Through this evidence-based research, we aim to improve the standard of care so healthcare professionals can optimize treatment for each patient.”

Hyperkalemia is a serious and overlooked condition that occurs when there is a defect in one or more of the mechanisms that maintain the balance of potassium in the body, most commonly because excretion of potassium by the kidneys is decreased. This can be due to acute kidney failure or decreasing kidney function such as in chronic kidney disease (CKD), advancing age, certain medical conditions or medications commonly used by people with cardiovascular and kidney disease.

Relypsa is presenting the following data at AMCP Nexus 2018 on Wednesday, October 24 from 12:30pm-2:30pm:

  • The Cost-Effectiveness Analysis of Patiromer and Renin-Angiotensin-Aldosterone System Inhibitors Therapy in Diabetic Nephropathy Patients with Hyperkalemia. Mark Bounthavong (Poster N4).
  • Real-World Utilization of Hyperkalemia Management Pharmacotherapy Among Medicare Advantage Patients. Robert Toto (Poster E38).        

About Hyperkalemia
Approximately three million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These may include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.

About Veltassa
Veltassa is a sodium-free potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (one-third of a cup) and taken once-a-day. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

Important Safety Information

Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.

Worsening of Gastrointestinal Motility 
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.

For Veltassa’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.

About Relypsa, Inc.
Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com.

About Vifor Pharma Group
Vifor Pharma Group, formerly Galenica Group, is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. 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. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.

Contact:
Albert Liao
Director of U.S. Communications
Relypsa
+1 650 421 9532
media@relypsa.com

Monday, October 22, 2018 - 08:00