January 18, 2018 3:33 AM ET

Pharmaceuticals

Company Overview of Relypsa, Inc.

Company Overview

Relypsa, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of polymeric medicines for patients with conditions that are overlooked and undertreated and can be addressed in the gastrointestinal tract primarily in the United States. The company offers Veltassa (patiromer), a non-absorbed potassium binding polymer for the treatment of hyperkalemia. It has license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. for developing and commercializing Veltassa outside the United States and Japan. The company was founded in 2007 and is headquartered in Redwood City, California. As of August 31, 2016, Relypsa, Inc. operates as a subsidiary of V...

100 Cardinal Way

Redwood City, CA 94063

United States

Founded in 2007

429 Employees

Phone:

650-421-9500

Key Executives for Relypsa, Inc.

President
Age: 48
Chief Scientific Officer and Senior Vice President
Age: 52
Chief Medical Officer and Senior Vice President
Age: 46
Senior Vice President, General Counsel and Secretary
Age: 55
Associate Director of Investor Relations and Corporate Affairs
Compensation as of Fiscal Year 2017.

Relypsa, Inc. Key Developments

Relypsa, Inc. Announces Presentation of New Clinical and Real-World Analyses of Veltassa at ASN Kidney Week 2017

Relypsa, Inc. announced results from a prespecified analysis of data from the Phase 4 TOURMALINE study of Veltassa (patiromer) for oral suspension. The purpose of this analysis was to demonstrate the effect of treatment with this non-absorbed potassium binder on key markers of mineral metabolism, including calcium and phosphate. The findings were presented in an oral session at the American Society of Nephrology's (ASN) Kidney Week 2017, taking place October 31-November 5, in New Orleans. Two additional abstracts evaluating treatment with Veltassa in a real-world setting with patients on hemodialysis were presented in a poster session. Effects of the potassium binding polymer patiromer on markers of mineral metabolism (Abstract: FR-OR068): The Phase 4 TOURMALINE study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive patiromer once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing patiromer treatment. This prespecified analysis of 112 evaluable patients evaluated key markers of mineral metabolism, including blood levels of parathyroid hormone (PTH), calcium and phosphate, and changes in 24-hour urine calcium and phosphate excretion. The findings, presented by David Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and chief of the Nephrology Division at the University of Rochester Medical Center, showed treatment with patiromer: Resulted in a statistically significant decrease in mean urine phosphate excretion (p4.8 mg/dL) from baseline to week 4. Decreased PTH levels toward the normal range (pOutcomes in end-stage renal disease patients on hemodialysis taking patiromer for hyperkalemia (Abstract: TH-PO779). An analysis of 268 end-stage renal disease patients on hemodialysis who were treated with patiromer at U.S.Fresenius Kidney Care centers assessed real-world outcomes over a six-month period. Patients included in the analysis had a mean of 4.9 years on dialysis. Results showed that patiromer lowered blood potassium levels in a real-world setting. Overall, blood potassium was reduced by 0.5 mEq/L, with the greatest effect occurring among patients with a baseline blood potassium level >6.5 mEq/L.

Relypsa, Inc. Announces European Commission Approval of Veltassa

Relypsa, Inc. announced that the European Commission (EC) has approved the Marketing Authorization Application (MAA) for Veltassa (patiromer) for the treatment of hyperkalemia, or elevated blood potassium levels. Veltassa, which is the brand name for patiromer in both the U.S. and Europe, is approved for marketing in all 28 EU countries and in Iceland, Liechtenstein and Norway. Vifor Pharma Group plans to launch Veltassa in Europe by the end of 2017 or in early 2018. In the EU, Veltassa is indicated for the treatment of adults with hyperkalemia, and the Summary of Product Characteristics (SmPC) notes that this includes those who develop hyperkalemia while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy. Nearly all patients treated with Veltassa in the clinical development program were on RAAS inhibitors at baseline. In the United States, Veltassa was approved by the U.S. Food and Drug Administration for the treatment of hyperkalemia in October 2015, becoming the first new medicine for this condition in more than 50 years. Marketing authorization applications for Veltassa have been submitted and are under review in Switzerland and Australia. Vifor Pharma plans to submit applications in other markets worldwide. Patients with advanced CKD and/or heart failure are especially susceptible to hyperkalemia, including the 3 million people in the United States who have stage 3 or 4 CKD and/or heart failure. 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 include RAAS inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs), angiotensin-converting-enzyme (ACE) inhibitors, and Mineralocorticoid Receptor Antagonists (MRA).

Relypsa, Inc. Presents Veltassa® Phase 4 Data Showing Consistent Efficacy and Safety Whether Taken with or without Food in Patients with Hyperkalemia

Relypsa, Inc. has announced that data from its Phase 4 TOURMALINE study of the effect of Veltassa® (patiromer) for oral suspension on hyperkalemia when taken with or without food were presented in a poster session at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings in Orlando, Fla. The results presented at the NKF meeting by Dr. Pergola showed no statistically significant difference in the percentage of patients achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L) between the groups taking Veltassa with or without food at either week 3 or week 4 follow-up (p=0.7893). Among study participants taking Veltassa with food, 87.3% achieved and maintained a potassium level in the target range as did 82.5% of those taking Veltassa without food. Results were consistent when evaluated by baseline potassium, race, eGFR (an assessment of kidney function) and type 2 diabetes. Patients with higher baseline potassium values generally had greater potassium reductions. Rates of adverse events were consistent with previous clinical trials of Veltassa and were similar between study participants who took Veltassa with food (48.2%) and those who took it without food (42.1%). The TOURMALINE study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive Veltassa once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment. The primary endpoint was a comparison of the proportion of patients with blood potassium in the target range (3.8 to 5.0 mEq/L) at week 3 or week 4 between the two treatment groups. Of the 112 evaluable patients, 65% were male, 65% were age 65 or older, and 62% had stage 3b-5 chronic kidney disease.

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